26 January 2018 EMA/270645/2015 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: tramadol
Procedure No.: PSUSA/00003002/201705
30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact
An agency of the European Union
© European Medicines Agency, 2018. Reproduction is authorised provided the source is acknowledged.
Product Name (in authorisation country) ADAMON 100 mg retard kemény kapszula ADAMON 100 mg retard kemény kapszula ADAMON 100 mg retard kemény kapszula ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
OGYI-T-6970/04
PHARMA HUNGARY
HU
not available
OGYI-T-6970/05
PHARMA HUNGARY
HU
not available
OGYI-T-6970/06
PHARMA HUNGARY
HU
UK/H/0306/001
034561338
MEDA KFT. MEDA KFT. MEDA KFT. MEDA
PHARMA S.P.A.
IT
UK/H/0306/001
034561340
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561011
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561023
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561353
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561035
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561365
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561050
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561391
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561377
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561047
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561389
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561403
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561062
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561415
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561074
MEDA PHARMA S.P.A.
IT
List of nationally authorised medicinal products EMA/140794/2018
Page 2/220
Product Name (in authorisation country) ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg compresse a rilascio prolungato ADAMON 150 mg retard kemény kapszula ADAMON 150 mg retard kemény kapszula ADAMON 150 mg retard kemény kapszula ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0306/001
034561427
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561441
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561439
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561086
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561466
MEDA PHARMA S.P.A.
IT
UK/H/0306/001
034561454
MEDA PHARMA S.P.A.
IT
not available
OGYI-T-6970/08
PHARMA HUNGARY
HU
not available
OGYI-T-6970/07
PHARMA HUNGARY
HU
not available
OGYI-T-6970/09
PHARMA HUNGARY
HU
UK/H/0306/002
034561478
MEDA KFT. MEDA KFT. MEDA KFT. MEDA
PHARMA S.P.A.
IT
UK/H/0306/002
034561480
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561098
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561100
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561112
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561492
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561504
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561528
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561124
MEDA PHARMA S.P.A.
IT
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Page 3/220
Product Name (in authorisation country) ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg compresse a rilascio prolungato ADAMON 200 mg retard kemény kapszula ADAMON 200 mg retard kemény kapszula ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0306/002
034561516
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561136
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561530
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561542
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561567
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561555
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561148
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561151
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561579
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561581
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561593
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561163
MEDA PHARMA S.P.A.
IT
UK/H/0306/002
034561605
MEDA PHARMA S.P.A.
IT
not available
OGYI-T-6970/10
HU
not available
OGYI-T-6970/11
UK/H/0306/003
034561617
MEDA PHARMA HUNGARY KFT. MEDA PHARMA HUNGARY KFT. MEDA PHARMA S.P.A.
UK/H/0306/003
034561175
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561629
MEDA PHARMA S.P.A.
IT
List of nationally authorised medicinal products EMA/140794/2018
HU IT
Page 4/220
Product Name (in authorisation country) ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato ADAMON 300 mg compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0306/003
034561187
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561631
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561199
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561643
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561656
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561201
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561670
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561668
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561682
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561213
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561225
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561706
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561694
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561237
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561718
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561720
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561732
MEDA PHARMA S.P.A.
IT
UK/H/0306/003
034561249
MEDA PHARMA S.P.A.
IT
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Product Name (in authorisation country) ADAMON 300 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0306/003
034561744
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561757
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561252
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561769
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561264
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561771
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561276
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561783
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561795
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561288
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561807
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561821
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561819
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561833
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561290
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561302
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561845
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561314
MEDA PHARMA S.P.A.
IT
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Page 6/220
Product Name (in authorisation country) ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato ADAMON 400 mg compresse a rilascio prolungato Adamon 50 mg Schmelztabletten ADAMON 50 mg retard kemény kapszula ADAMON 50 mg retard kemény kapszula ADAMON 50 mg retard kemény kapszula Adamon inject, 50 mg / ml Injektionslösung Adamon Kaps 50 mg, Hartkapseln Adamon long retard 150 mg-Filmtabletten Adamon long retard 200 mg-Filmtabletten Adamon long retard 300 mg-Filmtabletten Adamon long retard 400 mg-Filmtabletten Adamon SR 100 mg, tvrdé kapsuly s predĺženým uvoľňovaním Adamon SR 100, 100 mg, kapsułki o przedlużonym uwalnianiu
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0306/004
034561858
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561326
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561860
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561872
MEDA PHARMA S.P.A.
IT
UK/H/0306/004
034561884
MEDA PHARMA S.P.A.
IT
UK/H/0640/001
1-25733
MEDA PHARMA GMBH
AT
not available
OGYI-T-6970/01
PHARMA HUNGARY
HU
not available
OGYI-T-6970/02
PHARMA HUNGARY
HU
not available
OGYI-T-6970/03
PHARMA HUNGARY
HU
DE/H/0306/002
28667.00.00
PHARMA GMBH & CO.
DE
DE/H/0306/001
28661.00.00
PHARMA GMBH & CO.
DE
UK/H/0306/001
1-23430
MEDA KFT. MEDA KFT. MEDA KFT. MEDA KG MEDA KG MEDA
PHARMA GMBH
AT
UK/H/0306/002
1-23431
MEDA PHARMA GMBH
AT
UK/H/0306/003
1-23432
MEDA PHARMA GMBH
AT
UK/H/0306/004
1-23433
MEDA PHARMA GMBH
AT
UK/H/0301/002
65/0182/06-S
MEDA PHARMA GMBH & CO. KG
SK
not available
9361
MEDA PHARMA GMBH & CO. KG
PL
List of nationally authorised medicinal products EMA/140794/2018
Page 7/220
Product Name (in authorisation country) Adamon SR 150 mg, tvrdé kapsuly s predĺženým uvoľňovaním Adamon SR 150, 150 mg, kapsułki o przedlużonym uwalnianiu Adamon SR 200 mg, tvrdé kapsuly s predĺženým uvoľňovaním Adamon SR 200, 200 mg, kapsułki o przedlużonym uwalnianiu Adamon SR 50 mg, tvrdé kapsuly s predĺženým uvoľňovaním Adamon SR 50, 50 mg, kapsułki o przedlużonym uwalnianiu Adamon Tropfen 100 mg/ml Tropfen zum Einnehmen, Lösung Adolonta 100 mg/ 2 ml solución inyectable Adolonta 100 mg/ 2 ml solución inyectable Adolonta 100 mg/ml gotas orales en solución Adolonta 50 mg cápsulas duras Adolonta 50 mg cápsulas duras Adolonta 50 mg cápsulas duras Adolonta retard 100 mg comprimidos de liberación prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0301/003
65/0183/06-S
MEDA PHARMA GMBH & CO. KG
SK
not available
9362
MEDA PHARMA GMBH & CO. KG
PL
UK/H/0301/004
65/0185/06-S
MEDA PHARMA GMBH & CO. KG
SK
not available
9363
MEDA PHARMA GMBH & CO. KG
PL
UK/H/0301/001
65/0184/06-S
MEDA PHARMA GMBH & CO. KG
SK
not available
9360
MEDA PHARMA GMBH & CO. KG
PL
DE/H/0306/003
28664.00.00
MEDA PHARMA GMBH & CO. KG
DE
not available
59.086
GRÜNENTHAL PHARMA S.A.
ES
not available
59.086
GRÜNENTHAL PHARMA S.A.
ES
not available
61.617
GRÜNENTHAL PHARMA S.A.
ES
not available
59.088
GRÜNENTHAL PHARMA S.A.
ES
not available
59.088
GRÜNENTHAL PHARMA S.A.
ES
not available
59.088
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/001
61784
GRÜNENTHAL PHARMA S.A.
ES
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Page 8/220
Product Name (in authorisation country) Adolonta retard 100 mg comprimidos de liberación prolongada Adolonta retard 100 mg comprimidos de liberación prolongada Adolonta retard 100 mg comprimidos de liberación prolongada Adolonta retard 100 mg comprimidos de liberación prolongada Adolonta retard 100 mg comprimidos de liberación prolongada Adolonta retard 150 mg comprimidos de liberación prolongada Adolonta retard 150 mg comprimidos de liberación prolongada Adolonta retard 150 mg comprimidos de liberación prolongada Adolonta retard 150 mg comprimidos de liberación prolongada Adolonta retard 150 mg comprimidos de liberación prolongada Adolonta retard 150 mg comprimidos de liberación prolongada Adolonta retard 200 mg comprimidos de liberación prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/001
61784
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/001
61784
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/001
61784
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/001
61784
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/001
61784
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/002
61785
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/002
61785
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/002
61785
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/002
61785
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/002
61785
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/002
61785
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/003
61786
GRÜNENTHAL PHARMA S.A.
ES
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Page 9/220
Product Name (in authorisation country) Adolonta retard 200 mg comprimidos de liberación prolongada Adolonta retard 200 mg comprimidos de liberación prolongada Adolonta retard 200 mg comprimidos de liberación prolongada Adolonta retard 200 mg comprimidos de liberación prolongada Adolonta retard 200 mg comprimidos de liberación prolongada Adolonta retard 50 mg comprimidos de liberación prolongada Adolonta retard 50 mg comprimidos de liberación prolongada Adolonta retard 50 mg comprimidos de liberación prolongada Adolonta retard 50 mg comprimidos de liberación prolongada Adolonta retard 50 mg comprimidos de liberación prolongada Adolonta retard 50 mg comprimidos de liberación prolongada Amadol Retard 100 mg Hartkapseln, retardiert Amadol Retard 150 mg Hartkapseln, retardiert
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/003
61786
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/003
61786
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/003
61786
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/003
61786
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/003
61786
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/004
68570
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/004
68570
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/004
68570
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/004
68570
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/004
68570
GRÜNENTHAL PHARMA S.A.
ES
DE/H/0108/004
68570
GRÜNENTHAL PHARMA S.A.
ES
UK/H/0301/002
46342.01.00
DE
UK/H/0301/003
46342.02.00
MEDA PHARMA GMBH & CO. KG MEDA PHARMA GMBH & CO. KG
List of nationally authorised medicinal products EMA/140794/2018
DE
Page 10/220
Product Name (in authorisation country) Amadol Retard 200 mg Hartkapseln, retardiert Amadol Retard 50 mg Hartkapseln, retardiert Amadol® 100 mg Retardtabletten Amadol® 150 mg Retardtabletten Amadol® 200 mg Retardtabletten Amadol® Kapseln BIODALGIC 50 mg, comprimé effervescent BIODALGIC 50 mg, comprimé effervescent BIODALGIC 50 mg, comprimé effervescent BIODALGIC 50 mg, comprimé effervescent BIODALGIC 50 mg, comprimé effervescent BIODALGIC 50 mg, comprimé effervescent BIODALGIC 50 mg, comprimé effervescent BIODALGIC 50 mg, comprimé effervescent Brimisol PR 100 mg Prolonged-Release Tablet Brimisol PR 200 mg Prolonged-Release Tablet By-Madol SR 100 mg prolonged-release capsules, hard
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0301/004
46342.03.00
DE
UK/H/0301/001
46342.00.00
not available
42878.00.01
MEDA PHARMA GMBH & CO. KG MEDA PHARMA GMBH & CO. KG TAD PHARMA GMBH
not available
42878.01.01
TAD PHARMA GMBH
DE
not available
42878.02.01
TAD PHARMA GMBH
DE
not available not available
32283.00.00 561 772-2
TAD PHARMA GMBH BIOCODEX
DE FR
not available
350 673-4
BIOCODEX
FR
not available
561 772-2
BIOCODEX
FR
not available
350 673-4
BIOCODEX
FR
not available
561 772-2
BIOCODEX
FR
not available
350 673-4
BIOCODEX
FR
not available
561 772-2
BIOCODEX
FR
not available
350 673-4
BIOCODEX
FR
not available
17907/ 0134
UK
not available
17907/ 0136
DE/H/0639/002
PA 0549/016/002
BRISTOL LABORATORIES LTD (BERKHAMSTED) BRISTOL LABORATORIES LTD (BERKHAMSTED) ETHYPHARM
List of nationally authorised medicinal products EMA/140794/2018
DE DE
UK IE
Page 11/220
Product Name (in authorisation country) By-Madol SR 150 mg prolonged-release capsules, hard By-Madol SR 200 mg prolonged-release By-Madol SR 50 mg prolonged-release capsules, hard Ceparidin 50 mg capsulas EFG CONTRAMAL 100 mg compresse a rilascio prolungato Contramal 100 mg retard filmtabletta Contramal 100 mg retard filmtabletta Contramal 100 mg retard filmtabletta Contramal 100 mg retard filmtabletta CONTRAMAL 100 mg suppositoires Contramal 100 mg végbélkúp Contramal 100 mg végbélkúp CONTRAMAL 100 mg zetpillen CONTRAMAL 100 mg/2 ml oplossing voor injectie of infusie CONTRAMAL 100 mg/2 ml solution injectable ou pour perfusion
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0639/003
PA 0549/016/003
ETHYPHARM
IE
DE/H/0639/004
PA 0549/016/004
ETHYPHARM
IE
DE/H/0639/001
PA 0549/016/001
ETHYPHARM
IE
not available
64.448
ARAFARMA GROUP, S.A
ES
not available
028853036
GRÜNENTHAL ITALIA S.R.L.
IT
not available
OGYI-T-4975/08
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
OGYI-T-4975/07
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
OGYI-T-4975/08
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
OGYI-T-4975/07
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
BE 163064
SA GRÜNENTHAL N.V.
BE
not available
OGYI-T-4975/06
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
OGYI-T-4975/06
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
BE 163064
SA GRÜNENTHAL N.V.
BE
not available
BE 163037
SA GRÜNENTHAL N.V.
BE
not available
BE 163037
SA GRÜNENTHAL N.V.
BE
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Page 12/220
Product Name (in authorisation country) CONTRAMAL 100 mg/2 ml soluzione iniettabile CONTRAMAL 100 mg/2 ml, solution injectable Contramal 100 mg/ml belsőleges oldatos cseppek Contramal 100 mg/ml belsőleges oldatos cseppek Contramal 100 mg/ml belsőleges oldatos cseppek adagolópumpával Contramal 100 mg/ml belsőleges oldatos cseppek adagolópumpával CONTRAMAL 100 mg/ml druppels voor oraal gebruik, oplossing CONTRAMAL 100 mg/ml druppels voor oraal gebruik, oplossing CONTRAMAL 100 mg/ml gocce orali soluzione con contagocce CONTRAMAL 100 mg/ml solution buvable en gouttes CONTRAMAL 100 mg/ml solution buvable en gouttes CONTRAMAL 100 mg/ml soluzione orale con erogatore CONTRAMAL 100 mg/ml, solution buvable CONTRAMAL 150 mg compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
028853063
GRÜNENTHAL ITALIA S.R.L.
IT
not available
34009 561 113-9 8
FR
not available
OGYI-T-4975/04
LABORATOIRES GRÜNENTHAL S.A.S. TEVA GYÓGYSZERGYÁR ZRT
not available
OGYI-T-4975/04
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
OGYI-T-4975/05
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
OGYI-T-4975/05
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
BE 190836
SA GRÜNENTHAL N.V.
BE
not available
BE 163046
SA GRÜNENTHAL N.V.
BE
not available
028853024
GRÜNENTHAL ITALIA S.R.L.
IT
not available
BE 190836
SA GRÜNENTHAL N.V.
BE
not available
BE 163046
SA GRÜNENTHAL N.V.
BE
not available
028853101
GRÜNENTHAL ITALIA S.R.L.
IT
not available
34009 362 268 3 0
FR
DE/H/0108/002
028853 075
LABORATOIRES GRÜNENTHAL S.A.S. GRÜNENTHAL ITALIA S.R.L.
List of nationally authorised medicinal products EMA/140794/2018
HU
IT
Page 13/220
Product Name (in authorisation country) CONTRAMAL 150 mg compresse a rilascio prolungato CONTRAMAL 150 mg compresse a rilascio prolungato Contramal 150 mg retard filmtabletta Contramal 150 mg retard filmtabletta Contramal 150 mg retard filmtabletta Contramal 150 mg retard filmtabletta CONTRAMAL 200 mg compresse a rilascio prolungato CONTRAMAL 200 mg compresse a rilascio prolungato CONTRAMAL 200 mg compresse a rilascio prolungato Contramal 200 mg retard filmtabletta Contramal 200 mg retard filmtabletta Contramal 200 mg retard filmtabletta Contramal 200 mg retard filmtabletta CONTRAMAL 50 mg capsule rigide CONTRAMAL 50 mg capsules, hard CONTRAMAL 50 mg gélules
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/002
028853 075
GRÜNENTHAL ITALIA S.R.L.
IT
DE/H/0108/002
028853 075
GRÜNENTHAL ITALIA S.R.L.
IT
not available
OGYI-T-4975/10
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
OGYI-T-4975/09
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
OGYI-T-4975/10
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
OGYI-T-4975/09
TEVA GYÓGYSZERGYÁR ZRT
HU
DE/H/0108/003
028853 087
GRÜNENTHAL ITALIA S.R.L.
IT
DE/H/0108/003
028853 087
GRÜNENTHAL ITALIA S.R.L.
IT
DE/H/0108/003
028853 087
GRÜNENTHAL ITALIA S.R.L.
IT
not available
OGYI-T-4975/11
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
OGYI-T-4975/12
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
OGYI-T-4975/11
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
OGYI-T-4975/12
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
028853012
GRÜNENTHAL ITALIA S.R.L.
IT
not available
BE 163055
SA GRÜNENTHAL N.V.
BE
not available
BE163055
SA GRÜNENTHAL N.V.
BE
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Page 14/220
Product Name (in authorisation country) Contramal 50 mg kemény kapszula Contramal 50 mg kemény kapszula CONTRAMAL 50 mg, gélule
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
OGYI-T-4975/02
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
OGYI-T-4975/02
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
34009 300 022 8 5
FR
CONTRAMAL 50 mg, gélule
not available
34009 550 009 4 5
CONTRAMAL 50 mg, gélule
not available
34009 561 112 2 0
CONTRAMAL 50 mg, gélule
not available
34009 348 081 6 6
Contramal 50 mg/ml oldatos injekció Contramal 50 mg/ml oldatos injekció Contramal 50 mg/ml oldatos injekció Contramal 50 mg/ml oldatos injekció CONTRAMAL 50 mg/ml soluzione iniettabile Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée
not available
OGYI-T-4975/13
LABORATOIRES GRÜNENTHAL S.A.S. LABORATOIRES GRÜNENTHAL S.A.S. LABORATOIRES GRÜNENTHAL S.A.S. LABORATOIRES GRÜNENTHAL S.A.S. TEVA GYÓGYSZERGYÁR ZRT
not available
OGYI-T-4975/03
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
OGYI-T-4975/13
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
OGYI-T-4975/03
TEVA GYÓGYSZERGYÁR ZRT
HU
not available
028853051
GRÜNENTHAL ITALIA S.R.L.
IT
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
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FR FR FR HU
Page 15/220
Product Name (in authorisation country) Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
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Page 16/220
Product Name (in authorisation country) Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
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Page 17/220
Product Name (in authorisation country) Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
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Page 18/220
Product Name (in authorisation country) Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg comprimés à libération prolongée Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
2003070150
SA GRÜNENTHAL N.V.
LU
DE/H/0108/001
2003070150
SA GRÜNENTHAL N.V.
LU
DE/H/0108/001
2003070150
SA GRÜNENTHAL N.V.
LU
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
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Page 19/220
Product Name (in authorisation country) Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
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Page 20/220
Product Name (in authorisation country) Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
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Page 21/220
Product Name (in authorisation country) Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 100 mg tabletten met verlengde afgifte Contramal Retard 150 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE364743
SA GRÜNENTHAL N.V.
BE
DE/H/0108/001
BE188483
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
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Page 22/220
Product Name (in authorisation country) Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg comprimés à libération prolongée Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
2003070152
SA GRÜNENTHAL N.V.
LU
DE/H/0108/002
2003070152
SA GRÜNENTHAL N.V.
LU
DE/H/0108/002
2003070152
SA GRÜNENTHAL N.V.
LU
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE364752
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 150 mg tabletten met verlengde afgifte Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/002
BE188474
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg comprimés à libération prolongée Contramal Retard 200 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
2003070151
SA GRÜNENTHAL N.V.
LU
DE/H/0108/003
2003070151
SA GRÜNENTHAL N.V.
LU
DE/H/0108/003
2003070151
SA GRÜNENTHAL N.V.
LU
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 200 mg tabletten met verlengde afgifte Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE364761
SA GRÜNENTHAL N.V.
BE
DE/H/0108/003
BE188465
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
2007040035
SA GRÜNENTHAL N.V.
LU
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Product Name (in authorisation country) Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg comprimés à libération prolongée Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/004
2007040035
SA GRÜNENTHAL N.V.
LU
DE/H/0108/004
2007040035
SA GRÜNENTHAL N.V.
LU
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Retard 50 mg tabletten met verlengde afgifte Contramal Uno 100 mg comprimés à libération prolongée Contramal Uno 100 mg comprimés à libération prolongée Contramal Uno 100 mg comprimés à libération prolongée Contramal Uno 100 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290385
SA GRÜNENTHAL N.V.
BE
DE/H/0108/004
BE290376
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281662
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281671
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281671
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281653
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Uno 100 mg comprimés à libération prolongée Contramal Uno 100 mg comprimés à libération prolongée Contramal Uno 100 mg comprimés à libération prolongée Contramal Uno 100 mg comprimés à libération prolongée Contramal Uno 100 mg comprimés à libération prolongée Contramal Uno 100 mg comprimés à libération prolongée Contramal Uno 100 mg comprimés à libération prolongée Contramal Uno 100 mg comprimés à libération prolongée Contramal Uno 100 mg comprimés à libération prolongée Contramal Uno 100 mg comprimés à libération prolongée Contramal Uno 100 mg comprimés à libération prolongée Contramal Uno 100 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FR/H/0272/001
BE281671
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281671
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281662
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281671
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281671
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281662
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281662
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281662
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281662
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281662
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
0477/08040052
SA GRÜNENTHAL N.V.
LU
FR/H/0272/001
BE281671
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Uno 100 mg tabletten met verlengde afgifte Contramal Uno 100 mg tabletten met verlengde afgifte Contramal Uno 100 mg tabletten met verlengde afgifte Contramal Uno 100 mg tabletten met verlengde afgifte Contramal Uno 100 mg tabletten met verlengde afgifte Contramal Uno 100 mg tabletten met verlengde afgifte Contramal Uno 100 mg tabletten met verlengde afgifte Contramal Uno 100 mg tabletten met verlengde afgifte Contramal Uno 100 mg tabletten met verlengde afgifte Contramal Uno 100 mg tabletten met verlengde afgifte Contramal Uno 100 mg tabletten met verlengde afgifte Contramal Uno 100 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FR/H/0272/001
BE281662
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281671
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281662
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281671
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281671
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281662
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281671
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281662
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281653
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281662
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281671
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281662
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Uno 100 mg tabletten met verlengde afgifte Contramal Uno 100 mg tabletten met verlengde afgifte Contramal Uno 200 mg comprimés à libération prolongée Contramal Uno 200 mg comprimés à libération prolongée Contramal Uno 200 mg comprimés à libération prolongée Contramal Uno 200 mg comprimés à libération prolongée Contramal Uno 200 mg comprimés à libération prolongée Contramal Uno 200 mg comprimés à libération prolongée Contramal Uno 200 mg comprimés à libération prolongée Contramal Uno 200 mg comprimés à libération prolongée Contramal Uno 200 mg comprimés à libération prolongée Contramal Uno 200 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FR/H/0272/001
BE281662
SA GRÜNENTHAL N.V.
BE
FR/H/0272/001
BE281662
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281687
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281687
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281687
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281687
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281687
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Uno 200 mg comprimés à libération prolongée Contramal Uno 200 mg comprimés à libération prolongée Contramal Uno 200 mg comprimés à libération prolongée Contramal Uno 200 mg comprimés à libération prolongée Contramal Uno 200 mg comprimés à libération prolongée Contramal Uno 200 mg comprimés à libération prolongée Contramal Uno 200 mg tabletten met verlengde afgifte Contramal Uno 200 mg tabletten met verlengde afgifte Contramal Uno 200 mg tabletten met verlengde afgifte Contramal Uno 200 mg tabletten met verlengde afgifte Contramal Uno 200 mg tabletten met verlengde afgifte Contramal Uno 200 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FR/H/0272/002
BE281687
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281696
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
0477/08040053
SA GRÜNENTHAL N.V.
LU
FR/H/0272/002
BE281687
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281687
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
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Product Name (in authorisation country) Contramal Uno 200 mg tabletten met verlengde afgifte Contramal Uno 200 mg tabletten met verlengde afgifte Contramal Uno 200 mg tabletten met verlengde afgifte Contramal Uno 200 mg tabletten met verlengde afgifte Contramal Uno 200 mg tabletten met verlengde afgifte Contramal Uno 200 mg tabletten met verlengde afgifte Contramal Uno 200 mg tabletten met verlengde afgifte Contramal Uno 200 mg tabletten met verlengde afgifte Contramal Uno 200 mg tabletten met verlengde afgifte Contramal Uno 300 mg comprimés à libération prolongée Contramal Uno 300 mg comprimés à libération prolongée Contramal Uno 300 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FR/H/0272/002
BE281687
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281687
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281687
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281687
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281696
SA GRÜNENTHAL N.V.
BE
FR/H/0272/002
BE281705
SA GRÜNENTHAL N.V.
BE
FR/H/0272/003
BE281723
SA GRÜNENTHAL N.V.
BE
FR/H/0272/003
BE281714
SA GRÜNENTHAL N.V.
BE
FR/H/0272/003
BE281723
SA GRÜNENTHAL N.V.
BE
List of nationally authorised medicinal products EMA/140794/2018
Page 49/220
Product Name (in authorisation country) Contramal Uno 300 mg comprimés à libération prolongée Contramal Uno 300 mg comprimés à libération prolongée Contramal Uno 300 mg comprimés à libération prolongée Contramal Uno 300 mg comprimés à libération prolongée Contramal Uno 300 mg comprimés à libération prolongée Contramal Uno 300 mg tabletten met verlengde afgifte Contramal Uno 300 mg tabletten met verlengde afgifte Contramal Uno 300 mg tabletten met verlengde afgifte Contramal Uno 300 mg tabletten met verlengde afgifte Contramal Uno 300 mg tabletten met verlengde afgifte Contramal Uno 300 mg tabletten met verlengde afgifte Contramal Uno 300 mg tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FR/H/0272/003
BE281723
SA GRÜNENTHAL N.V.
BE
FR/H/0272/003
BE281723
SA GRÜNENTHAL N.V.
BE
FR/H/0272/003
BE281723
SA GRÜNENTHAL N.V.
BE
FR/H/0272/003
BE281723
SA GRÜNENTHAL N.V.
BE
FR/H/0272/003
0477/08040054
SA GRÜNENTHAL N.V.
LU
FR/H/0272/003
BE281723
SA GRÜNENTHAL N.V.
BE
FR/H/0272/003
BE281723
SA GRÜNENTHAL N.V.
BE
FR/H/0272/003
BE281723
SA GRÜNENTHAL N.V.
BE
FR/H/0272/003
BE281723
SA GRÜNENTHAL N.V.
BE
FR/H/0272/003
BE281714
SA GRÜNENTHAL N.V.
BE
FR/H/0272/003
BE281723
SA GRÜNENTHAL N.V.
BE
FR/H/0272/003
BE281723
SA GRÜNENTHAL N.V.
BE
List of nationally authorised medicinal products EMA/140794/2018
Page 50/220
Product Name (in authorisation country) Dolatramyl 100 mg Depottabletter Dolatramyl 100 mg depottabletter Dolatramyl 100 mg depottabletter Dolatramyl 100 mg depottabletti Dolatramyl 150 mg Depottabletter Dolatramyl 150 mg depottabletter Dolatramyl 150 mg depottabletter Dolatramyl 150 mg depottabletti Dolatramyl 200 mg Depottabletter Dolatramyl 200 mg depottabletter Dolatramyl 200 mg depottabletter Dolatramyl 200 mg depottabletti Dolol Retard UNO, depotkapsler, hårde Dolol Retard UNO, depotkapsler, hårde Dolol Retard UNO, depotkapsler, hårde Dolol, brusetabletter Dolol, hårde kapsler DOLPAR 100 mg comprimidos de liberación prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/4160/001
48179
MYLAN AB
DK
UK/H/4160/001
10-8115
MYLAN AB
NO
UK/H/4160/001
45573
MYLAN AB
SE
UK/H/4160/001
29450
MYLAN AB
FI
UK/H/4160/002
48180
MYLAN AB
DK
UK/H/4160/002
10-8116
MYLAN AB
NO
UK/H/4160/002
45574
MYLAN AB
SE
UK/H/4160/002
29451
MYLAN AB
FI
UK/H/4160/002
48181
MYLAN AB
DK
UK/H/4160/003
10-8117
MYLAN AB
NO
UK/H/4160/003
45575
MYLAN AB
SE
UK/H/4160/003
29452
MYLAN AB
FI
FI/H/0164/001
33911
TAKEDA PHARMA A/S
DK
FI/H/0164/002
33912
TAKEDA PHARMA A/S
DK
FI/H/0164/003
33913
TAKEDA PHARMA A/S
DK
not available DK/H/0141/002 FR/H/0272/001
19173 18099 67.585
TAKEDA PHARMA A/S TAKEDA PHARMA A/S LABORATORIOS DR. ESTEVE S.A.
DK DK ES
List of nationally authorised medicinal products EMA/140794/2018
Page 51/220
Product Name (in authorisation country) DOLPAR 200 mg comprimidos de liberación prolongada DOLPAR 300 mg comprimidos de liberación prolongada Dolzam 100 mg/ml druppels voor oraal gebruik, oplossing Dolzam 100 mg/ml solution buvable en gouttes Dolzam 50 mg capsules, hard Dolzam 50 mg gélules Dolzam 50 mg/ml ampoules, solution injectable Dolzam 50 mg/ml ampullen, oplossing voor injectie Dolzam Retard 100 mg comprimés à libération prolongée Dolzam Retard 100 mg comprimés à libération prolongée Dolzam Retard 100 mg comprimés à libération prolongée Dolzam Retard 100 mg tabletten met verlengde afgifte Dolzam Retard 100 mg tabletten met verlengde afgifte Dolzam Retard 150 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FR/H/0272/002
67.586
LABORATORIOS DR. ESTEVE S.A.
ES
FR/H/0272/003
67.587
LABORATORIOS DR. ESTEVE S.A.
ES
not available
BE168585
ZAMBON NV
BE
not available
BE168585
ZAMBON NV
BE
not available
BE168594
ZAMBON NV
BE
not available not available
BE168594 BE168603
ZAMBON NV ZAMBON NV
BE BE
not available
BE168603
ZAMBON NV
BE
UK/H/0330/002
BE232434
ZAMBON NV
BE
UK/H/0330/002
BE370194
ZAMBON NV
BE
UK/H/0330/002
0411/11071217
ZAMBON NV
LU
UK/H/0330/002
BE232434
ZAMBON NV
BE
UK/H/0330/002
BE370194
ZAMBON NV
BE
UK/H/0330/003
BE232443
ZAMBON NV
BE
List of nationally authorised medicinal products EMA/140794/2018
Page 52/220
Product Name (in authorisation country) Dolzam Retard 150 mg comprimés à libération prolongée Dolzam Retard 150 mg comprimés à libération prolongée Dolzam Retard 150 mg tabletten met verlengde afgifte Dolzam Retard 150 mg tabletten met verlengde afgifte Dolzam Retard 200 mg comprimés à libération prolongée Dolzam Retard 200 mg comprimés à libération prolongée Dolzam Retard 200 mg comprimés à libération prolongée Dolzam Retard 200 mg tabletten met verlengde afgifte Dolzam Retard 200 mg tabletten met verlengde afgifte Dolzam Retard 75 mg comprimés à libération prolongée Dolzam Retard 75 mg comprimés à libération prolongée Dolzam Retard 75 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0330/003
BE370203
ZAMBON NV
BE
UK/H/0330/003
0411/10120898
ZAMBON NV
LU
UK/H/0330/003
BE232443
ZAMBON NV
BE
UK/H/0330/003
BE370203
ZAMBON NV
BE
UK/H/0330/004
BE232452
ZAMBON NV
BE
UK/H/0330/004
BE370212
ZAMBON NV
BE
UK/H/0330/004
0411/10120899
ZAMBON NV
LU
UK/H/0330/004
BE232452
ZAMBON NV
BE
UK/H/0330/004
BE370212
ZAMBON NV
BE
UK/H/0330/001
BE232425
ZAMBON NV
BE
UK/H/0330/001
BE370185
ZAMBON NV
BE
UK/H/0330/001
0411/10120896
ZAMBON NV
LU
List of nationally authorised medicinal products EMA/140794/2018
Page 53/220
Product Name (in authorisation country) Dolzam Retard 75 mg tabletten met verlengde afgifte Dolzam Retard 75 mg tabletten met verlengde afgifte DOLZAM UNO 150 mg comprimés à libération prolongée DOLZAM UNO 150 mg comprimés à libération prolongée DOLZAM UNO 150 mg comprimés à libération prolongée DOLZAM UNO 200 mg comprimés à libération prolongée DOLZAM UNO 200 mg comprimés à libération prolongée Dolzam Uno 200 mg comprimés à libération prolongée Dolzam Uno 200 mg tabletten met verlengde afgifte DOLZAM UNO 200 mg tabletten met verlengde afgifte DOLZAM UNO 300 mg comprimés à libération prolongée DOLZAM UNO 300 mg comprimés à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0330/001
BE232425
ZAMBON NV
BE
UK/H/0330/001
BE370185
ZAMBON NV
BE
UK/H/0306/001
BE207916
ZAMBON NV
BE
UK/H/0306/001
BE370221
ZAMBON NV
BE
UK/H/0306/001
0411/10120894
ZAMBON NV
LU
UK/H/0306/002
BE207925
ZAMBON NV
BE
UK/H/0306/002
BE370237
ZAMBON NV
BE
UK/H/0306/002
0411/10120893
ZAMBON NV
LU
UK/H/0306/002
BE207925
ZAMBON NV
BE
UK/H/0306/002
BE370237
ZAMBON NV
BE
UK/H/0306/003
BE207934
ZAMBON NV
BE
UK/H/0306/003
BE370246
ZAMBON NV
BE
List of nationally authorised medicinal products EMA/140794/2018
Page 54/220
Product Name (in authorisation country) Dolzam Uno 300 mg comprimés à libération prolongée Dolzam Uno 300 mg tabletten met verlengde afgifte DOLZAM UNO 300 mg tabletten met verlengde afgifte DOLZAM UNO 400 mg comprimés à libération prolongée Dolzam Uno 400 mg comprimés à libération prolongée Dolzam Uno 400 mg tabletten met verlengde afgifte FORTRADOL 100 mg compresse a rilascio prolungato FORTRADOL 100 mg/2 ml soluzione iniettabile FORTRADOL 100 mg/ml gocce orali soluzione con contagocce FORTRADOL 150 mg compresse a rilascio prolungato FORTRADOL 200 mg compresse a rilascio prolungato FORTRADOL 50 mg capsule rigide FORTRADOL 50 mg/ml soluzione iniettabile
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0306/003
0411/10120892
ZAMBON NV
LU
UK/H/0306/003
BE207934
ZAMBON NV
BE
UK/H/0306/003
BE370246
ZAMBON NV
BE
UK/H/0306/004
BE370255
ZAMBON NV
BE
UK/H/0306/004
0411/10120895
ZAMBON NV
LU
UK/H/0306/004
BE370255
ZAMBON NV
BE
not available
028878092
ALFA WASSERMANN SPA
IT
not available
028878128
ALFA WASSERMANN SPA
IT
not available
028878080
ALFA WASSERMANN SPA
IT
not available
028878142
ALFA WASSERMANN SPA
IT
not available
028878155
ALFA WASSERMANN SPA
IT
not available
028878078
ALFA WASSERMANN SPA
IT
not available
028878116
ALFA WASSERMANN SPA
IT
List of nationally authorised medicinal products EMA/140794/2018
Page 55/220
Product Name (in authorisation country) GELOTRADOL 100 mg cápsulas duras de liberación prolongada GELOTRADOL 150 mg cápsulas duras de liberación prolongada GELOTRADOL 200 mg cápsulas duras de liberación prolongada GELOTRADOL 50 mg cápsulas duras de liberación prolongada GELOTRALIB 100 mg cápsulas de libertação prolongada GELOTRALIB 100 mg cápsulas de libertação prolongada GELOTRALIB 100 mg cápsulas de libertação prolongada GELOTRALIB 150 mg cápsulas de libertação prolongada GELOTRALIB 150 mg cápsulas de libertação prolongada GELOTRALIB 150 mg cápsulas de libertação prolongada GELOTRALIB 200 mg cápsulas de libertação prolongada GELOTRALIB 200 mg cápsulas de libertação prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0639/002
68.501
FERRER INTERNACIONAL, S.A.
ES
DE/H/0639/003
68.502
FERRER INTERNACIONAL, S.A.
ES
DE/H/0639/004
68503
FERRER INTERNACIONAL, S.A.
ES
DE/H/0639/001
68.500
FERRER INTERNACIONAL, S.A.
ES
DE/H/0639/002
5010731
FERRER INTERNACIONAL, S.A.
PT
DE/H/0639/002
5010749
FERRER INTERNACIONAL, S.A.
PT
DE/H/0639/002
5010756
FERRER INTERNACIONAL, S.A.
PT
DE/H/0639/003
5010764
FERRER INTERNACIONAL, S.A.
PT
DE/H/0639/003
5010772
FERRER INTERNACIONAL, S.A.
PT
DE/H/0639/003
5010806
FERRER INTERNACIONAL, S.A.
PT
DE/H/0639/004
5010814
FERRER INTERNACIONAL, S.A.
PT
DE/H/0639/004
5010822
FERRER INTERNACIONAL, S.A.
PT
List of nationally authorised medicinal products EMA/140794/2018
Page 56/220
Product Name (in authorisation country) GELOTRALIB 200 mg cápsulas de libertação prolongada GELOTRALIB 50 mg cápsulas de libertação prolongada GELOTRALIB 50 mg cápsulas de libertação prolongada GELOTRALIB 50 mg cápsulas de libertação prolongada Gemadol 100 mg depotkapsel, hård Gemadol 150 mg depotkapsel, hård Gemadol 200 mg depotkapsel, hård Gemadol 50 mg depotkapsel, hård Gemadol Retard Gemadol Retard Gemadol Retard Gemadol Retard Lanalget retard 100 mgFilmtabletten Lanalget retard 150 mgFilmtabletten Lanalget retard 200 mgFilmtabletten Larapam 100mg SR Tablets Larapam 150mg SR Tablets Larapam 200mg SR Tablets LUMIDOL 100 mg/2 ml otopina za injekcije
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0639/004
5010830
FERRER INTERNACIONAL, S.A.
PT
DE/H/0639/001
5010707
FERRER INTERNACIONAL, S.A.
PT
DE/H/0639/001
5010715
FERRER INTERNACIONAL, S.A.
PT
DE/H/0639/001
5010723
FERRER INTERNACIONAL, S.A.
PT
UK/H/0225/002
14064
MEDA AB
SE
UK/H/0225/003
14065
MEDA AB
SE
UK/H/0225/004
14066
MEDA AB
SE
UK/H/0225/001
14063
MEDA AB
SE
UK/H/0225/002 UK/H/0225/003 UK/H/0225/001 UK/H/0225/004 AT/H/0117/001
19326 19327 19325 19328 1–23123
MEDA AS MEDA AS MEDA AS MEDA AS G.L. PHARMA GMBH
DK DK DK DK AT
AT/H/0117/002
1–24030
G.L. PHARMA GMBH
AT
AT/H/0117/003
1–24031
G.L. PHARMA GMBH
AT
NL/H/0483/001 NL/H/0483/002 NL/H/0483/003 not available
PL 04416/0596 PL 04416/0597 PL 04416/0598 UP/I-530-09/12-02/89
SANDOZ LTD SANDOZ LTD SANDOZ LTD BELUPO D.D.
UK UK UK HR
List of nationally authorised medicinal products EMA/140794/2018
Page 57/220
Product Name (in authorisation country) LUMIDOL 100 mg/ml oralne kapi LUMIDOL 50 mg tvrde kapsule LUMIDOL 50 mg/ml otopina za injekcije Lumidol retard 100 mg tablete s produljenim oslobađanjem Lumidol retard 100 mg tablete s produljenim oslobađanjem Lumidol retard 200 mg tablete s produljenim oslobađanjem MABRON MABRON 100 mg/2 ml, injekcní roztok Mabron 100mg Prolonged Release Tablets Mabron 100mg/2ml solution for injection/infusion Mabron 150mg Prolonged Release Tablets Mabron 200mg Prolonged Release Tablets MABRON 50 mg MABRON 50 mg capsule MABRON 50 mg capsule MABRON 50 mg capsule Mabron 50 mg capsules Mabron 50 mg cietās kapsulas MABRON 50 mg tvrdé tobolky
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
UP/I-530-09/12-02/92
BELUPO D.D.
HR
not available
UP/I-530-09/12-02/91
BELUPO D.D.
HR
not available
UP/I-530-09/12-02/88
BELUPO D.D.
HR
not available
HR-H-864156880
BELUPO D.D.
HR
not available
HR-H-864156880
BELUPO D.D.
HR
not available
HR-H-947867682
BELUPO D.D.
HR
not available not available
65/0459/94-S 65/788/94-C
MEDOCHEMIE LTD. MEDOCHEMIE LTD.
SK CZ
NL/H/0538/001
PL 20117/0003
UK
not available
13185
MORNINGSIDE HEALTHCARE LTD MEDOCHEMIE LTD.
NL/H/0538/002
PL 20117/0004
UK
NL/H/0538/003
PL 20117/0005
not not not not not not
available available available available available available
65/0076/93-S 8728/2016/01 8728/2016/02 8728/2016/03 12119 02-0247
MORNINGSIDE HEALTHCARE LTD MORNINGSIDE HEALTHCARE LTD MEDOCHEMIE LTD. MEDOCHEMIE LTD. MEDOCHEMIE LTD. MEDOCHEMIE LTD. MEDOCHEMIE LTD. MEDOCHEMIE LTD.
not available
65/1000/93-C
MEDOCHEMIE LTD.
CZ
List of nationally authorised medicinal products EMA/140794/2018
CY
UK SK RO RO RO CY LV
Page 58/220
Product Name (in authorisation country) MABRON 50 mg/ml injekcinis tirpalas Mabron 50 mg/ml šķīdums injekcijām vai infūzijām Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
LT/1/98/3123/001
MEDOCHEMIE LTD.
LT
not available
02-0248
MEDOCHEMIE LTD.
LV
not available
7244/2014/01
MEDOCHEMIE LTD.
RO
not available
7244/2014/02
MEDOCHEMIE LTD.
RO
not available
7244/2014/03
MEDOCHEMIE LTD.
RO
not available
7244/2014/04
MEDOCHEMIE LTD.
RO
not available
7244/2014/05
MEDOCHEMIE LTD.
RO
not available
7244/2014/06
MEDOCHEMIE LTD.
RO
not available
7244/2014/07
MEDOCHEMIE LTD.
RO
not available
7244/2014/08
MEDOCHEMIE LTD.
RO
not available
7244/2014/09
MEDOCHEMIE LTD.
RO
not available
7244/2014/10
MEDOCHEMIE LTD.
RO
not available
7244/2014/11
MEDOCHEMIE LTD.
RO
List of nationally authorised medicinal products EMA/140794/2018
Page 59/220
Product Name (in authorisation country) Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
7244/2014/12
MEDOCHEMIE LTD.
RO
not available
7244/2014/13
MEDOCHEMIE LTD.
RO
not available
7244/2014/14
MEDOCHEMIE LTD.
RO
not available
7244/2014/15
MEDOCHEMIE LTD.
RO
not available
7244/2014/16
MEDOCHEMIE LTD.
RO
not available
7244/2014/17
MEDOCHEMIE LTD.
RO
not available
7244/2014/18
MEDOCHEMIE LTD.
RO
not available
7244/2014/19
MEDOCHEMIE LTD.
RO
not available
7244/2014/20
MEDOCHEMIE LTD.
RO
not available
7244/2014/21
MEDOCHEMIE LTD.
RO
not available
7244/2014/22
MEDOCHEMIE LTD.
RO
not available
7244/2014/23
MEDOCHEMIE LTD.
RO
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Page 60/220
Product Name (in authorisation country) Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita Mabron retard 100 mg comprimate cu eliberare prelungita MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
7244/2014/24
MEDOCHEMIE LTD.
RO
not available
7244/2014/25
MEDOCHEMIE LTD.
RO
not available
7244/2014/26
MEDOCHEMIE LTD.
RO
not available
7244/2014/27
MEDOCHEMIE LTD.
RO
not available
7244/2014/28
MEDOCHEMIE LTD.
RO
not available
7244/2014/29
MEDOCHEMIE LTD.
RO
not available
7244/2014/30
MEDOCHEMIE LTD.
RO
NL/H/0889/001
LT/1/07/0754/001
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/002
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/003
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/004
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/005
MEDOCHEMIE LTD.
LT
List of nationally authorised medicinal products EMA/140794/2018
Page 61/220
Product Name (in authorisation country) MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0889/001
LT/1/07/0754/006
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/007
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/008
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/009
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/010
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/011
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/012
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/013
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/014
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/015
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/016
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/017
MEDOCHEMIE LTD.
LT
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Page 62/220
Product Name (in authorisation country) MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes MABRON RETARD 100 mg pailginto atpalaidavimo tabletes
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0889/001
LT/1/07/0754/018
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/019
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/020
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/021
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/022
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/023
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/024
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/025
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/026
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/027
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/028
MEDOCHEMIE LTD.
LT
NL/H/0889/001
LT/1/07/0754/029
MEDOCHEMIE LTD.
LT
List of nationally authorised medicinal products EMA/140794/2018
Page 63/220
Product Name (in authorisation country) MABRON RETARD 100 mg pailginto atpalaidavimo tabletes Mabron Retard 100 mg prolonged-release tablets MABRON RETARD 100 mg tablety s predlženým uvolnovaním Mabron retard 100 mg δισκία παρατεταμένης αποδέσμευσης MABRON RETARD 100 tablety s prodlouženým uvolňováním Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0889/001
LT/1/07/0754/030
MEDOCHEMIE LTD.
LT
NL/H/0889/001
MA032/06701
MEDOCHEMIE LTD.
MT
NL/H/0538/001
65/0275/05-S
MEDOCHEMIE LTD.
SK
NL/H/0889/001
20240
MEDOCHEMIE LTD.
CY
NL/H/0538/001
65/369/05-C
MEDOCHEMIE LTD.
CZ
not available
7245/2014/01
MEDOCHEMIE LTD.
RO
not available
7245/2014/02
MEDOCHEMIE LTD.
RO
not available
7245/2014/03
MEDOCHEMIE LTD.
RO
not available
7245/2014/04
MEDOCHEMIE LTD.
RO
not available
7245/2014/05
MEDOCHEMIE LTD.
RO
not available
7245/2014/06
MEDOCHEMIE LTD.
RO
not available
7245/2014/07
MEDOCHEMIE LTD.
RO
List of nationally authorised medicinal products EMA/140794/2018
Page 64/220
Product Name (in authorisation country) Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
7245/2014/08
MEDOCHEMIE LTD.
RO
not available
7245/2014/09
MEDOCHEMIE LTD.
RO
not available
7245/2014/10
MEDOCHEMIE LTD.
RO
not available
7245/2014/11
MEDOCHEMIE LTD.
RO
not available
7245/2014/12
MEDOCHEMIE LTD.
RO
not available
7245/2014/13
MEDOCHEMIE LTD.
RO
not available
7245/2014/14
MEDOCHEMIE LTD.
RO
not available
7245/2014/15
MEDOCHEMIE LTD.
RO
not available
7245/2014/16
MEDOCHEMIE LTD.
RO
not available
7245/2014/17
MEDOCHEMIE LTD.
RO
not available
7245/2014/18
MEDOCHEMIE LTD.
RO
not available
7245/2014/19
MEDOCHEMIE LTD.
RO
List of nationally authorised medicinal products EMA/140794/2018
Page 65/220
Product Name (in authorisation country) Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita Mabron retard 150 mg comprimate cu eliberare prelungita MABRON RETARD 150 mg pailginto atpalaidavimo tabletes
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
7245/2014/20
MEDOCHEMIE LTD.
RO
not available
7245/2014/21
MEDOCHEMIE LTD.
RO
not available
7245/2014/22
MEDOCHEMIE LTD.
RO
not available
7245/2014/23
MEDOCHEMIE LTD.
RO
not available
7245/2014/24
MEDOCHEMIE LTD.
RO
not available
7245/2014/25
MEDOCHEMIE LTD.
RO
not available
7245/2014/26
MEDOCHEMIE LTD.
RO
not available
7245/2014/27
MEDOCHEMIE LTD.
RO
not available
7245/2014/28
MEDOCHEMIE LTD.
RO
not available
7245/2014/29
MEDOCHEMIE LTD.
RO
not available
7245/2014/30
MEDOCHEMIE LTD.
RO
NL/H/0889/002
LT/1/07/0754/031
MEDOCHEMIE LTD.
LT
List of nationally authorised medicinal products EMA/140794/2018
Page 66/220
Product Name (in authorisation country) MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0889/002
LT/1/07/0754/032
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/033
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/034
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/035
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/036
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/037
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/038
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/039
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/040
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/041
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/042
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/043
MEDOCHEMIE LTD.
LT
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Page 67/220
Product Name (in authorisation country) MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0889/002
LT/1/07/0754/044
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/045
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/046
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/047
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/048
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/049
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/050
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/051
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/052
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/053
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/055
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/056
MEDOCHEMIE LTD.
LT
List of nationally authorised medicinal products EMA/140794/2018
Page 68/220
Product Name (in authorisation country) MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletes MABRON RETARD 150 mg pailginto atpalaidavimo tabletės Mabron Retard 150 mg prolonged-release tablets MABRON RETARD 150 mg tablety s predlženým uvolnovaním Mabron retard 150 mg δισκία παρατεταμένης αποδέσμευσης MABRON RETARD 150 tablety s prodlouženým uvolnováním Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0889/002
LT/1/07/0754/057
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/058
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/059
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/060
MEDOCHEMIE LTD.
LT
NL/H/0889/002
LT/1/07/0754/054
MEDOCHEMIE LTD.
LT
NL/H/0889/002
MA032/06702
MEDOCHEMIE LTD.
MT
NL/H/0538/002
65/0285/05-S
MEDOCHEMIE LTD.
SK
NL/H/0889/002
20241
MEDOCHEMIE LTD.
CY
NL/H/0538/002
65/370/05-C
MEDOCHEMIE LTD.
CZ
not available
7246/2014/01
MEDOCHEMIE LTD.
RO
not available
7246/2014/02
MEDOCHEMIE LTD.
RO
not available
7246/2014/03
MEDOCHEMIE LTD.
RO
List of nationally authorised medicinal products EMA/140794/2018
Page 69/220
Product Name (in authorisation country) Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
7246/2014/04
MEDOCHEMIE LTD.
RO
not available
7246/2014/05
MEDOCHEMIE LTD.
RO
not available
7246/2014/06
MEDOCHEMIE LTD.
RO
not available
7246/2014/07
MEDOCHEMIE LTD.
RO
not available
7246/2014/08
MEDOCHEMIE LTD.
RO
not available
7246/2014/09
MEDOCHEMIE LTD.
RO
not available
7246/2014/10
MEDOCHEMIE LTD.
RO
not available
7246/2014/11
MEDOCHEMIE LTD.
RO
not available
7246/2014/12
MEDOCHEMIE LTD.
RO
not available
7246/2014/13
MEDOCHEMIE LTD.
RO
not available
7246/2014/14
MEDOCHEMIE LTD.
RO
not available
7246/2014/15
MEDOCHEMIE LTD.
RO
List of nationally authorised medicinal products EMA/140794/2018
Page 70/220
Product Name (in authorisation country) Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
7246/2014/16
MEDOCHEMIE LTD.
RO
not available
7246/2014/17
MEDOCHEMIE LTD.
RO
not available
7246/2014/18
MEDOCHEMIE LTD.
RO
not available
7246/2014/19
MEDOCHEMIE LTD.
RO
not available
7246/2014/20
MEDOCHEMIE LTD.
RO
not available
7246/2014/21
MEDOCHEMIE LTD.
RO
not available
7246/2014/22
MEDOCHEMIE LTD.
RO
not available
7246/2014/23
MEDOCHEMIE LTD.
RO
not available
7246/2014/24
MEDOCHEMIE LTD.
RO
not available
7246/2014/25
MEDOCHEMIE LTD.
RO
not available
7246/2014/26
MEDOCHEMIE LTD.
RO
not available
7246/2014/27
MEDOCHEMIE LTD.
RO
List of nationally authorised medicinal products EMA/140794/2018
Page 71/220
Product Name (in authorisation country) Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita Mabron retard 200 mg comprimate cu eliberare prelungita MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
7246/2014/28
MEDOCHEMIE LTD.
RO
not available
7246/2014/29
MEDOCHEMIE LTD.
RO
not available
7246/2014/30
MEDOCHEMIE LTD.
RO
NL/H/0889/003
LT/1/07/0754/062
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/064
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/065
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/066
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/067
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/068
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/069
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/070
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/071
MEDOCHEMIE LTD.
LT
List of nationally authorised medicinal products EMA/140794/2018
Page 72/220
Product Name (in authorisation country) MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0889/003
LT/1/07/0754/072
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/073
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/074
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/075
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/076
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/077
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/078
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/079
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/080
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/081
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/082
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/083
MEDOCHEMIE LTD.
LT
List of nationally authorised medicinal products EMA/140794/2018
Page 73/220
Product Name (in authorisation country) MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletes MABRON RETARD 200 mg pailginto atpalaidavimo tabletės MABRON RETARD 200 mg pailginto atpalaidavimo tabletės Mabron Retard 200 mg prolonged-release tablets MABRON RETARD 200 mg tablety s predlženým uvolnovaním Mabron retard 200 mg δισκία παρατεταμένης αποδέσμευσης
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0889/003
LT/1/07/0754/084
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/085
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/086
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/087
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/088
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/089
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/090
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/061
MEDOCHEMIE LTD.
LT
NL/H/0889/003
LT/1/07/0754/063
MEDOCHEMIE LTD.
LT
NL/H/0889/003
MA032/06703
MEDOCHEMIE LTD.
MT
NL/H/0538/003
65/0286/05-S
MEDOCHEMIE LTD.
SK
NL/H/0889/003
20239
MEDOCHEMIE LTD.
CY
List of nationally authorised medicinal products EMA/140794/2018
Page 74/220
Product Name (in authorisation country) MABRON RETARD 200 tablety s prodlouženým uvolnováním Mabron retard, 100 mg toimeainet modifitseeritult vabastavad tabletid Mabron retard, 150 mg toimeainet modifitseeritult vabastavad tabletid Mabron retard, 200 mg toimeainet modifitseeritult vabastavad tabletid MABRON soluţie injectabilă MABRON soluţie injectabilă MABRON soluţie injectabilă MABRON SR 100 mg ilgstošās darbības tabletes MABRON SR 150 mg ilgstošās darbības tabletes MABRON SR 200 mg ilgstošās darbības tabletes Mabron, 50 mg/ml süstevõi infusioonilahus Mandolgin Mandolgin Mandolgin Mandolgin Retard Mandolgin Retard Mandolgin Retard Mandolgin Retard Mandolgin Uno Mandolgin Uno Mandolgin Uno Mandolgin Uno Maneo 100 mg Prolongedrelease tablets
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0538/003
65/371/05-C
MEDOCHEMIE LTD.
CZ
NL/H/0538/001
493405
MEDOCHEMIE LTD.
EE
NL/H/0538/002
493605
MEDOCHEMIE LTD.
EE
NL/H/0538/003
493505
MEDOCHEMIE LTD.
EE
not available not available not available NL/H/0538/001
7314/2006/01 7314/2006/02 7314/2006/03 05-0500
MEDOCHEMIE MEDOCHEMIE MEDOCHEMIE MEDOCHEMIE
LTD. LTD. LTD. LTD.
RO RO RO LV
NL/H/0538/002
05-0501
MEDOCHEMIE LTD.
LV
NL/H/0538/003
05-0502
MEDOCHEMIE LTD.
LV
not available
340701
MEDOCHEMIE LTD.
EE
not available not available not available not available not available not available not available not available not available not available not available UK/H/4160/001
18666 18665 19352 19423 19424 19426 19425 19085 19086 19087 19088 PL 04569/1406
SANDOZ A/S SANDOZ A/S SANDOZ A/S SANDOZ A/S SANDOZ A/S SANDOZ A/S SANDOZ A/S SANDOZ A/S SANDOZ A/S SANDOZ A/S SANDOZ A/S GENERICS [UK] LIMITED
DK DK DK DK DK DK DK DK DK DK DK UK
List of nationally authorised medicinal products EMA/140794/2018
Page 75/220
Product Name (in authorisation country) Maneo 150 mg Prolongedrelease tablets Maneo 200 mg Prolongedrelease tablets Marol 100mg Prolongedrelease tablets Marol 150mg Prolongedrelease tablets Marol 200mg Prolongedrelease tablets MAXITRAM SR 100 mg prolonged-release capsule, hard MAXITRAM SR 150 mg prolonged-release capsule, hard MAXITRAM SR 200 mg prolonged-release capsule, hard MAXITRAM SR 50 mg prolonged-release capsule, hard MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/4160/002
PL 04569/1407
GENERICS [UK] LIMITED
UK
UK/H/4160/003
PL 04569/1408
GENERICS [UK] LIMITED
UK
not available
PL 20117/0045
UK
not available
PL 20117/0046
not available
PL 20117/0047
DE/H/0639/002
PL 08829/0163
MORNINGSIDE HEALTHCARE LTD MORNINGSIDE HEALTHCARE LTD MORNINGSIDE HEALTHCARE LTD CHIESI LIMITED
DE/H/0639/003
PL 08829/0164
CHIESI LIMITED
UK
DE/H/0639/004
PL 08829/0165
CHIESI LIMITED
UK
DE/H/0639/001
PL 08829/0162
CHIESI LIMITED
UK
not available
367 870-2
SANOFI-AVENTIS FRANCE
FR
not available
367 872-5
SANOFI-AVENTIS FRANCE
FR
not available
367 873-1
SANOFI-AVENTIS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
UK UK UK
Page 76/220
Product Name (in authorisation country) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
367 871-9
SANOFI-AVENTIS FRANCE
FR
not available
566 383-4
SANOFI-AVENTIS FRANCE
FR
not available
367 869-4
SANOFI-AVENTIS FRANCE
FR
not available
566 385-7
SANOFI-AVENTIS FRANCE
FR
not available
367 877-7
SANOFI-AVENTIS FRANCE
FR
not available
566 384-0
SANOFI-AVENTIS FRANCE
FR
not available
367 875-4
SANOFI-AVENTIS FRANCE
FR
not available
367 878-3
SANOFI-AVENTIS FRANCE
FR
not available
367 876-0
SANOFI-AVENTIS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 77/220
Product Name (in authorisation country) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
367 874-8
SANOFI-AVENTIS FRANCE
FR
not available
367 870-2
SANOFI-AVENTIS FRANCE
FR
not available
367 872-5
SANOFI-AVENTIS FRANCE
FR
not available
367 873-1
SANOFI-AVENTIS FRANCE
FR
not available
367 871-9
SANOFI-AVENTIS FRANCE
FR
not available
566 383-4
SANOFI-AVENTIS FRANCE
FR
not available
367 869-4
SANOFI-AVENTIS FRANCE
FR
not available
566 385-7
SANOFI-AVENTIS FRANCE
FR
not available
367 877-7
SANOFI-AVENTIS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 78/220
Product Name (in authorisation country) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 100 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
566 384-0
SANOFI-AVENTIS FRANCE
FR
not available
367 875-4
SANOFI-AVENTIS FRANCE
FR
not available
367 878-3
SANOFI-AVENTIS FRANCE
FR
not available
367 876-0
SANOFI-AVENTIS FRANCE
FR
not available
367 874-8
SANOFI-AVENTIS FRANCE
FR
not available
367 945-2
SANOFI-AVENTIS FRANCE
FR
not available
566 520-1
SANOFI-AVENTIS FRANCE
FR
not available
367 944-6
SANOFI-AVENTIS FRANCE
FR
not available
367 942-3
SANOFI-AVENTIS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 79/220
Product Name (in authorisation country) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
367 941-7
SANOFI-AVENTIS FRANCE
FR
not available
367 940-0
SANOFI-AVENTIS FRANCE
FR
not available
367 947-5
SANOFI-AVENTIS FRANCE
FR
not available
367 948-1
SANOFI-AVENTIS FRANCE
FR
not available
566 521-8
SANOFI-AVENTIS FRANCE
FR
not available
566 522-4
SANOFI-AVENTIS FRANCE
FR
not available
367 950-6
SANOFI-AVENTIS FRANCE
FR
not available
367 949-8
SANOFI-AVENTIS FRANCE
FR
not available
367 946-9
SANOFI-AVENTIS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 80/220
Product Name (in authorisation country) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
367 945-2
SANOFI-AVENTIS FRANCE
FR
not available
566 520-1
SANOFI-AVENTIS FRANCE
FR
not available
367 944-6
SANOFI-AVENTIS FRANCE
FR
not available
367 942-3
SANOFI-AVENTIS FRANCE
FR
not available
367 941-7
SANOFI-AVENTIS FRANCE
FR
not available
367 940-0
SANOFI-AVENTIS FRANCE
FR
not available
367 947-5
SANOFI-AVENTIS FRANCE
FR
not available
367 948-1
SANOFI-AVENTIS FRANCE
FR
not available
566 521-8
SANOFI-AVENTIS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 81/220
Product Name (in authorisation country) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 200 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
566 522-4
SANOFI-AVENTIS FRANCE
FR
not available
367 950-6
SANOFI-AVENTIS FRANCE
FR
not available
367 949-8
SANOFI-AVENTIS FRANCE
FR
not available
367 946-9
SANOFI-AVENTIS FRANCE
FR
not available
367 953-5
SANOFI-AVENTIS FRANCE
FR
not available
367 952-9
SANOFI-AVENTIS FRANCE
FR
not available
367 951-2
SANOFI-AVENTIS FRANCE
FR
not available
367 954-1
SANOFI-AVENTIS FRANCE
FR
not available
367 955-8
SANOFI-AVENTIS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 82/220
Product Name (in authorisation country) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
566 523-0
SANOFI-AVENTIS FRANCE
FR
not available
368 089-2
SANOFI-AVENTIS FRANCE
FR
not available
368 092-3
SANOFI-AVENTIS FRANCE
FR
not available
566 525-3
SANOFI-AVENTIS FRANCE
FR
not available
566 524-7
SANOFI-AVENTIS FRANCE
FR
not available
368 091-7
SANOFI-AVENTIS FRANCE
FR
not available
368 090-0
SANOFI-AVENTIS FRANCE
FR
not available
368 094-6
SANOFI-AVENTIS FRANCE
FR
not available
367 953-5
SANOFI-AVENTIS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 83/220
Product Name (in authorisation country) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
367 952-9
SANOFI-AVENTIS FRANCE
FR
not available
367 951-2
SANOFI-AVENTIS FRANCE
FR
not available
367 954-1
SANOFI-AVENTIS FRANCE
FR
not available
367 955-8
SANOFI-AVENTIS FRANCE
FR
not available
566 523-0
SANOFI-AVENTIS FRANCE
FR
not available
368 089-2
SANOFI-AVENTIS FRANCE
FR
not available
368 092-3
SANOFI-AVENTIS FRANCE
FR
not available
566 525-3
SANOFI-AVENTIS FRANCE
FR
not available
566 524-7
SANOFI-AVENTIS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 84/220
Product Name (in authorisation country) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOALGIC LP 300 MG, COMPRIME A LIBERATION PROLONGÉE ( UNE PRISE QUOTIDIENNE) MONOCRIXO L.P. 100 mg, gélule à libération prolongée (UNE PRISE QUOTIDIENNE) MONOCRIXO L.P. 100 mg, gélule à libération prolongée (UNE PRISE QUOTIDIENNE) MONOCRIXO L.P. 100 mg, gélule à libération prolongée (UNE PRISE QUOTIDIENNE) MONOCRIXO L.P. 100 mg, gélule à libération prolongée (UNE PRISE QUOTIDIENNE) MONOCRIXO L.P. 100 mg, gélule à libération prolongée (UNE PRISE QUOTIDIENNE) MONOCRIXO L.P. 150 mg, gélule à libération prolongée (UNE PRISE QUOTIDIENNE) MONOCRIXO L.P. 150 mg, gélule à libération prolongée (UNE PRISE QUOTIDIENNE) MONOCRIXO L.P. 150 mg, gélule à libération prolongée (UNE PRISE QUOTIDIENNE)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
368 091-7
SANOFI-AVENTIS FRANCE
FR
not available
368 090-0
SANOFI-AVENTIS FRANCE
FR
not available
368 094-6
SANOFI-AVENTIS FRANCE
FR
FI/H/0164/001
34009 362 470 6 2
THERABEL LUCIEN PHARMA S.A.
FR
FI/H/0164/001
34009 362 471 2 3
THERABEL LUCIEN PHARMA S.A.
FR
FI/H/0164/001
34009 362 472 9 1
THERABEL LUCIEN PHARMA S.A.
FR
FI/H/0164/001
34009 362 473 5 2
THERABEL LUCIEN PHARMA S.A.
FR
FI/H/0164/001
34009 362 474 1 3
THERABEL LUCIEN PHARMA S.A.
FR
FI/H/0164/002
34009 362 475 8 1
THERABEL LUCIEN PHARMA S.A.
FR
FI/H/0164/002
34009 362 476 4 2
THERABEL LUCIEN PHARMA S.A.
FR
FI/H/0164/002
34009 362 477 0 3
THERABEL LUCIEN PHARMA S.A.
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 85/220
Product Name (in authorisation country) MONOCRIXO L.P. 150 mg, gélule à libération prolongée (UNE PRISE QUOTIDIENNE) MONOCRIXO L.P. 150 mg, gélule à libération prolongée (UNE PRISE QUOTIDIENNE) MONOCRIXO L.P. 200 mg, gélule à libération prolongée (UNE PRISE QUOTIDIENNE) MONOCRIXO L.P. 200 mg, gélule à libération prolongée (UNE PRISE QUOTIDIENNE) MONOCRIXO L.P. 200 mg, gélule à libération prolongée (UNE PRISE QUOTIDIENNE) MONOCRIXO L.P. 200 mg, gélule à libération prolongée (UNE PRISE QUOTIDIENNE) MONOCRIXO L.P. 200 mg, gélule à libération prolongée (UNE PRISE QUOTIDIENNE) MONOTRAMAL L.P. 100 mg, comprimé à libération prolongée (UNE PRISE QUOTIDIENNE) MONOTRAMAL L.P. 200 mg, comprimé à libération prolongée (UNE PRISE QUOTIDIENNE) MONOTRAMAL L.P. 300 mg, comprimé à libération prolongée (UNE PRISE QUOTIDIENNE) Noax uno 100 mg Retardtabletten Noax Uno 100 mg, tabletki o przedluzonym uwalnianiu
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FI/H/0164/002
34009 362 478 7 1
THERABEL LUCIEN PHARMA S.A.
FR
FI/H/0164/002
34009 362 479 3 2
THERABEL LUCIEN PHARMA S.A.
FR
FI/H/0164/003
34009 362 480 1 4
THERABEL LUCIEN PHARMA S.A.
FR
FI/H/0164/003
34009 362 481 8 2
THERABEL LUCIEN PHARMA S.A.
FR
FI/H/0164/003
34009 362 482 4 3
THERABEL LUCIEN PHARMA S.A.
FR
FI/H/0164/003
34009 362 483 0 4
THERABEL LUCIEN PHARMA S.A.
FR
FI/H/0164/003
34009 362 484 7 2
THERABEL LUCIEN PHARMA S.A.
FR
FR/H/0272/001
NL28699
ENDO VENTURES LIMITED
FR
FR/H/0272/002
NL28700
ENDO VENTURES LIMITED
FR
FR/H/0272/003
NL28701
ENDO VENTURES LIMITED
FR
FR/H/0272/001
1-26327
AT
FR/H/0272/001
12067
ANGELINI PHARMA ÖSTERREICH GMBH ANGELINI PHARMA ÖSTERREICH GMBH
List of nationally authorised medicinal products EMA/140794/2018
PL
Page 86/220
Product Name (in authorisation country) Noax uno 200 mg Retardtabletten Noax Uno 200 mg, tabletki o przedłużonym uwalnianiu Noax uno 300 mg Retardtabletten Noax Uno 300 mg, tabletki o przedluzonym uwalnianiu Nobligan 100 mg/ml orala droppar, lösning Nobligan 50 mg hörð hylki Nobligan 50 mg kapslar, hårda Nobligan 50 mg kapsler, harde Nobligan Retard 100 mg depottabletter Nobligan retard 100 mg depottabletter Nobligan retard 100 mg depottabletter Nobligan retard 100 mg depottabletter Nobligan Retard 100 mg forðatöflur Nobligan Retard 150 mg depottabletter Nobligan retard 150 mg depottabletter Nobligan retard 150 mg depottabletter Nobligan retard 150 mg depottabletter Nobligan Retard 150 mg forðatöflur
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FR/H/0272/002
1-26329
AT
FR/H/0272/002
12064
FR/H/0272/003
1-26331
FR/H/0272/003
12063
not available
14305
ANGELINI PHARMA ÖSTERREICH GMBH ANGELINI PHARMA ÖSTERREICH GMBH ANGELINI PHARMA ÖSTERREICH GMBH ANGELINI PHARMA ÖSTERREICH GMBH GRÜNENTHAL GMBH
not available not available
910181 12845
GRÜNENTHAL GMBH GRÜNENTHAL GMBH
IS SE
not available
8268
GRÜNENTHAL GMBH
NO
not available
98-2970
GRÜNENTHAL GMBH
NO
DE/H/0108/001
13287
GRÜNENTHAL GMBH
SE
DE/H/0108/001
13287
GRÜNENTHAL GMBH
SE
DE/H/0108/001
13287
GRÜNENTHAL GMBH
SE
not available
980423
GRÜNENTHAL GMBH
IS
not available
98-2971
GRÜNENTHAL GMBH
NO
DE/H/0108/002
13288
GRÜNENTHAL GMBH
SE
DE/H/0108/002
13288
GRÜNENTHAL GMBH
SE
DE/H/0108/002
13288
GRÜNENTHAL GMBH
SE
not available
980424
GRÜNENTHAL GMBH
IS
List of nationally authorised medicinal products EMA/140794/2018
PL AT PL SE
Page 87/220
Product Name (in authorisation country) Nobligan Retard 200 mg depottabletter Nobligan retard 200 mg depottabletter Nobligan retard 200 mg depottabletter Nobligan retard 200 mg depottabletter Nobligan Retard 200 mg forðatöflur Nobligan Retard, depottabletter 100 mg Nobligan Retard, depottabletter 100 mg Nobligan Retard, depottabletter 100 mg Nobligan Retard, depottabletter 150 mg Nobligan Retard, depottabletter 150 mg Nobligan Retard, depottabletter 150 mg Nobligan Retard, depottabletter 200 mg Nobligan Retard, depottabletter 200 mg Nobligan Retard, depottabletter 200 mg Nobligan, kapsler, hårde Nobligan, orale dråber, opløsning ORATRAM 100 100 mg, tabletki o przedluzonym uwalnianiu
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
98-2972
GRÜNENTHAL GMBH
NO
DE/H/0108/003
13289
GRÜNENTHAL GMBH
SE
DE/H/0108/003
13289
GRÜNENTHAL GMBH
SE
DE/H/0108/003
13289
GRÜNENTHAL GMBH
SE
not available
980425
GRÜNENTHAL GMBH
IS
DE/H/0108/001
18540
GRÜNENTHAL GMBH
DK
DE/H/0108/001
18540
GRÜNENTHAL GMBH
DK
DE/H/0108/001
18540
GRÜNENTHAL GMBH
DK
DE/H/0108/002
18541
GRÜNENTHAL GMBH
DK
DE/H/0108/002
18541
GRÜNENTHAL GMBH
DK
DE/H/0108/002
18541
GRÜNENTHAL GMBH
DK
DE/H/0108/003
18542
GRÜNENTHAL GMBH
DK
DE/H/0108/003
18542
GRÜNENTHAL GMBH
DK
DE/H/0108/003
18542
GRÜNENTHAL GMBH
DK
not available not available
14623 14624
GRÜNENTHAL GMBH GRÜNENTHAL GMBH
DK DK
NL/H/0888/001
14313
MOLTENI FARMACEUTICI POLSKA SP. Z O.O.
PL
List of nationally authorised medicinal products EMA/140794/2018
Page 88/220
Product Name (in authorisation country) ORATRAM 150 150 mg, tabletki o przedluzonym uwalnianiu ORATRAM 200 200 mg, tabletki o przedłużonym uwalnianiu OROZAMUDOL 50 mg, comprimé orodispersible OROZAMUDOL 50 mg, comprimé orodispersible OROZAMUDOL 50 mg, comprimé orodispersible OROZAMUDOL 50 mg, comprimé orodispersible OROZAMUDOL 50 mg, comprimé orodispersible OROZAMUDOL 50 mg, comprimé orodispersible OROZAMUDOL 50 mg, comprimé orodispersible OROZAMUDOL 50 mg, comprimé orodispersible OROZAMUDOL 50 mg, comprimé orodispersible Paxilfar 100 mg/ 2 ml solution for injection
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0888/002
14315
MOLTENI FARMACEUTICI POLSKA SP. Z O.O.
PL
NL/H/0888/003
14314
MOLTENI FARMACEUTICI POLSKA SP. Z O.O.
PL
UK/H/0640/001
366 004.3
MEDA PHARMA SAS
FR
UK/H/0640/001
366 003.7
MEDA PHARMA SAS
FR
UK/H/0640/001
366 002.0
MEDA PHARMA SAS
FR
UK/H/0640/001
366 001.4
MEDA PHARMA SAS
FR
UK/H/0640/001
366 000.8
MEDA PHARMA SAS
FR
UK/H/0640/001
366 515.4
MEDA PHARMA SAS
FR
UK/H/0640/001
366 514.8
MEDA PHARMA SAS
FR
UK/H/0640/001
366 513.1
MEDA PHARMA SAS
FR
UK/H/0640/001
366 512.5
MEDA PHARMA SAS
FR
not available
9515411
PT
Paxilfar 100mg tablets
not available
6/13/84
Poltram, 100 mg/ml, krople doustne, roztwór Poltram, 100 mg/ml, krople doustne, roztwór PRONTALGIN 50 mg Compresse effervescenti
not available
9690
not available
9690
NL/H/0113/005
033074042
TECNIFAR, INDÚSTRIA TÉCNICA FARMACÊUTICA, SA TECNIFAR, INDÚSTRIA TÉCNICA FARMACÊUTICA, SA MEDANA PHARMA SPOLKA AKCYJNA MEDANA PHARMA SPOLKA AKCYJNA THERABEL GIENNE PHARMA S.P.A.
List of nationally authorised medicinal products EMA/140794/2018
PT PL PL IT
Page 89/220
Product Name (in authorisation country) PRONTALGIN 50 mg Compresse effervescenti PRONTALGIN 50 mg Compresse effervescenti PRONTALGIN 50 mg/ml soluzione iniettabile PRONTALGIN Capsule, 50 mg capsule rigide PRONTALGIN Gocce, 100 mg/ml gocce orali, soluzione Ralgen 50 mg kemény kapszula Ralgen 50 mg kemény kapszula Ralgen SR 100 mg retard tabletta Ralgen SR 100 mg retard tabletta Ralgen SR 100 mg retard tabletta Ralgen SR 100 mg retard tabletta Ralgen SR 150 mg retard tabletta Ralgen SR 150 mg retard tabletta Ralgen SR 150 mg retard tabletta Ralgen SR 150 mg retard tabletta Ralgen SR 200 mg retard tabletta Ralgen SR 200 mg retard tabletta Ralgen SR 200 mg retard tabletta
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0113/005
033074055
PHARMA
IT
NL/H/0113/005
033074067
PHARMA
IT
NL/H/0113/001
033074028
PHARMA
IT
NL/H/0113/002
033074030
PHARMA
IT
NL/H/0113/003
033074016
PHARMA
IT
not available
OGYI-T-20310/15
THERABEL GIENNE S.P.A. THERABEL GIENNE S.P.A. THERABEL GIENNE S.P.A. THERABEL GIENNE S.P.A. THERABEL GIENNE S.P.A. ZENTIVA, A.S.
not available
OGYI-T-20310/14
ZENTIVA, A.S.
HU
not available
OGYI-T-20310/04
ZENTIVA, A.S.
HU
not available
OGYI-T-20310/05
ZENTIVA, A.S.
HU
not available
OGYI-T-20310/03
ZENTIVA, A.S.
HU
not available
OGYI-T-20310/02
ZENTIVA, A.S.
HU
not available
OGYI-T-20310/07
ZENTIVA, A.S.
HU
not available
OGYI-T-20310/09
ZENTIVA, A.S.
HU
not available
OGYI-T-20310/08
ZENTIVA, A.S.
HU
not available
OGYI-T-20310/06
ZENTIVA, A.S.
HU
not available
OGYI-T-20310/12
ZENTIVA, A.S.
HU
not available
OGYI-T-20310/11
ZENTIVA, A.S.
HU
not available
OGYI-T-20310/13
ZENTIVA, A.S.
HU
List of nationally authorised medicinal products EMA/140794/2018
HU
Page 90/220
Product Name (in authorisation country) Ralgen SR 200 mg retard tabletta Rofy 100mg/2ml, solution for injection or infusion Rofy 50 mg capsules Rofy retard 100 mg δισκία παρατεταμένης αποδέσμευσης Rofy retard 150 mg δισκία παρατεταμένης αποδέσμευσης Rofy retard 200 mg δισκία παρατεταμένης αποδέσμευσης Tadol 100 mg svečke Tadol 100 mg svečke Tadol 100 mg tablete s podaljšanim sproščanjem Tadol 100 mg/ml peroralne kapljice, raztopina Tadol 100 mg/ml peroralne kapljice, raztopina Tadol 150 mg tablete s podaljšanim sproščanjem Tadol 200 mg tablete s podaljšanim sproščanjem Tadol 50 mg trde kapsule Tadol 50 mg/ml raztopina za injiciranje/infundiranje Tadol 50 mg/ml raztopina za injiciranje/infundiranje Tadol 50 mg/ml raztopina za injiciranje/infundiranje Tadol 50 mg/ml raztopina za injiciranje/infundiranje Tadol, kapsler, hårde
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
OGYI-T-20310/10
ZENTIVA, A.S.
HU
not available
20016
CODAL SYNTO LTD
CY
not available NL/H/0888/001
20017 20236
CODAL SYNTO LTD CODAL SYNTO LTD
CY CY
NL/H/0888/002
20237
CODAL SYNTO LTD
CY
NL/H/0888/003
20238
CODAL SYNTO LTD
CY
NP/H/0828/006 NP/H/0828/006 NP/H/0828/002
H/93/01481/005 H/93/01481/005 H/93/01481/001
KRKA, D.D., NOVO MESTO KRKA, D.D., NOVO MESTO KRKA, D.D., NOVO MESTO
SI SI SI
NP/H/0828/005
H/93/01481/006
KRKA, D.D., NOVO MESTO
SI
NP/H/0828/005
H/93/01481/007
KRKA, D.D., NOVO MESTO
SI
NP/H/0828/003
H/93/01481/002
KRKA, D.D., NOVO MESTO
SI
NP/H/0828/004
H/93/01481/003
KRKA, D.D., NOVO MESTO
SI
NP/H/0828/001 NP/H/0829/001
H/93/01481/004 H/93/01481/010
KRKA, D.D., NOVO MESTO KRKA, D.D., NOVO MESTO
SI SI
NP/H/0829/001
H/93/01481/011
KRKA, D.D., NOVO MESTO
SI
NP/H/0829/001
H/93/01481/008
KRKA, D.D., NOVO MESTO
SI
NP/H/0829/001
H/93/01481/009
KRKA, D.D., NOVO MESTO
SI
DE/H/0282/001
32972
PHARMACODANE APS
DK
List of nationally authorised medicinal products EMA/140794/2018
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Product Name (in authorisation country) Tadol, suppositorier TAKADOL® 100 mg, comprimé effervescent sécable TAKADOL® 100 mg, comprimé effervescent sécable TAKADOL® 100 mg, comprimé effervescent sécable THERADOL 50 mg Bruistabletten THERADOL Capsules, capsules 50 mg, hard THERADOL Druppels, druppels 100 mg/ml THERADOL Injectie, oplossing voor injectie 50 mglml Tilodol SR 100 mg Prolonged-Release Tablets Tilodol SR 150 mg Prolonged-Release Tablets Tilodol SR 200 mg Prolonged-Release Tablets Tioner 100 mg/ml gotas orales en solución Tioner 50 mg cápsulas duras
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0282/003 not available
32974 355 314-2
PHARMACODANE APS LABORATOIRES EXPANSCIENCE
DK FR
not available
355 315-9
LABORATOIRES EXPANSCIENCE
FR
not available
355 316-5
LABORATOIRES EXPANSCIENCE
FR
NL/H/0113/005
RVG24573
THERABEL PHARMA N.V.
NL
NL/H/0113/002
RVG 17779
THERABEL PHARMA N.V.
NL
NL/H/0113/003
RVG 17780
THERABEL PHARMA N.V.
NL
NL/H/0113/001
RVG 17778
THERABEL PHARMA N.V.
NL
DE/H/0448/001
PL 04416/1237
SANDOZ LTD
UK
DE/H/0448/002
PL 04416/1238
SANDOZ LTD
UK
DE/H/0448/003
PL 04416/1239
SANDOZ LTD
UK
not available
62015
ES
not available
62.016
Tioner retard 100 mg comprimidos de liberación prolongada Tioner retard 150 mg comprimidos de liberación prolongada
not available
62919
ARISTO PHARMA IBERIA, S.L. ARISTO PHARMA IBERIA, S.L. ARISTO PHARMA IBERIA, S.L.
not available
62920
ARISTO PHARMA IBERIA, S.L.
ES
List of nationally authorised medicinal products EMA/140794/2018
ES ES
Page 92/220
Product Name (in authorisation country) Tioner retard 200 mg comprimidos de liberación prolongada Tiparol 50 mg brustablett
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
62921
ARISTO PHARMA IBERIA, S.L.
ES
not available
14106
SE
Tiparol 50 mg brustablett
not available
14106
Tiparol 50 mg hård kapsel
not available
13347
Tiparol 50 mg hård kapsel
not available
13347
T-long ® 100 mg Retardkapseln Hartkapsel, retardiert Wirkstoff: Tramadolhydrochlorid T-long ® 150 mg Retardkapseln Hartkapsel, retardiert Wirkstoff: Tramadolhydrochlorid T-long ® 200 mg Retardkapseln Hartkapsel, retardiert Wirkstoff: Tramadolhydrochlorid TOPALGIC 100 mg/2 ml, solution injectable en ampoule TOPALGIC 100 mg/2 ml, solution injectable en ampoule TOPALGIC 100 MG/ML SOLUTION BUVABLE TOPALGIC 100 MG/ML SOLUTION BUVABLE TOPALGIC 50 MG, GÉLULE TOPALGIC 50 MG, GÉLULE TOPALGIC 50 MG, GÉLULE
FI/H/0164/001
54607.00.00
BLUEFISH PHARMACEUTICALS AB BLUEFISH PHARMACEUTICALS AB BLUEFISH PHARMACEUTICALS AB BLUEFISH PHARMACEUTICALS AB LABORATOIRES SMB S.A.
FI/H/0164/002
54607.01.00
LABORATOIRES SMB S.A.
DE
FI/H/0164/003
54607.02.00
LABORATOIRES SMB S.A.
DE
not available
558 881-9
SANOFI-AVENTIS FRANCE
FR
not available
558 881-9
SANOFI-AVENTIS FRANCE
FR
not available
362 067-7
SANOFI-AVENTIS FRANCE
FR
not available
362 067-7
SANOFI-AVENTIS FRANCE
FR
not available not available not available
558 878-8 339 118-8 34009 300 022 7 8
SANOFI-AVENTIS FRANCE SANOFI-AVENTIS FRANCE SANOFI-AVENTIS FRANCE
FR FR FR
List of nationally authorised medicinal products EMA/140794/2018
SE SE SE DE
Page 93/220
Product Name (in authorisation country) TOPALGIC 50 MG, GÉLULE TOPALGIC 50 MG, GÉLULE TOPALGIC 50 MG, GÉLULE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 mg, comprimé à libération prolongée TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 mg, comprimé à libération prolongée TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available not available not available DE/H/0108/001
558 878-8 339 118-8 34009 300 022 7 8 351 621-8
SANOFI-AVENTIS SANOFI-AVENTIS SANOFI-AVENTIS SANOFI-AVENTIS
FRANCE FRANCE FRANCE FRANCE
FR FR FR FR
DE/H/0108/001
560 421-1
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
343 141-0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
560 422-8
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
343 142-7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
351 622-4
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
351 621-8
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
560 421-1
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
343 141-0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
560 422-8
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
343 142-7
SANOFI-AVENTIS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
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Product Name (in authorisation country) TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 mg, comprimé à libération prolongée TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 mg, comprimé à libération prolongée TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/001
351 622-4
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
351 621-8
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
560 421-1
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
343 141-0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
560 422-8
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
343 142-7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
351 622-4
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
351 621-8
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
560 421-1
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
343 141-0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
560 422-8
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
343 142-7
SANOFI-AVENTIS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
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Product Name (in authorisation country) TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 mg, comprimé à libération prolongée TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 100 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 mg, comprimé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/001
351 622-4
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
351 621-8
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
560 421-1
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
343 141-0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
560 422-8
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
343 142-7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/001
351 622-4
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
560 423-4
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
351 623-0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
343 143-3
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
343 145-6
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
560 424-0
SANOFI-AVENTIS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 96/220
Product Name (in authorisation country) TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 mg, comprimé à libération prolongée TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 mg, comprimé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/002
351 624-7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
560 423-4
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
351 623-0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
343 143-3
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
343 145-6
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
560 424-0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
351 624-7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
560 423-4
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
351 623-0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
343 143-3
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
343 145-6
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
560 424-0
SANOFI-AVENTIS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 97/220
Product Name (in authorisation country) TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 mg, comprimé à libération prolongée TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 150 mg, comprimé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/002
351 624-7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
560 423-4
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
351 623-0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
343 143-3
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
343 145-6
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
560 424-0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
351 624-7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
560 423-4
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
351 623-0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
343 143-3
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
343 145-6
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/002
560 424-0
SANOFI-AVENTIS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 98/220
Product Name (in authorisation country) TOPALGIC LP 150 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 mg, comprimé à libération prolongée TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/002
351 624-7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
351 625-3
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
560 425-7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
343 146-2
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
351 627-6
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
34009 343 147 9 7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
34009 5604263 0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
351 625-3
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
560 425-7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
343 146-2
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
351 627-6
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
34009 343 147 9 7
SANOFI-AVENTIS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 99/220
Product Name (in authorisation country) TOPALGIC LP 200 mg, comprimé à libération prolongée TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 mg, comprimé à libération prolongée TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/003
34009 5604263 0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
351 625-3
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
560 425-7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
343 146-2
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
351 627-6
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
34009 343 147 9 7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
34009 5604263 0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
351 625-3
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
560 425-7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
343 146-2
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
351 627-6
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
34009 343 147 9 7
SANOFI-AVENTIS FRANCE
FR
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Page 100/220
Product Name (in authorisation country) TOPALGIC LP 200 mg, comprimé à libération prolongée TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 MG, COMPRIMÉ À LIBÉRATION PROLONGÉE TOPALGIC LP 200 mg, comprimé à libération prolongée Toram 50 mg kapsule Tradol 50 mg Effervescent Tablets Tradol 50mg Hard Capsules Tradol 50mg/ml Solution for Injection or Infusion Tradol SR 100 mg Prolonged Release Tablets Tradol SR 150 mg Prolonged Release Tablets Tradol SR 200 mg Prolonged Release Tablets Tradolan 100 mg-Ampullen Tradolan 100 mg-Zäpfchen
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/003
34009 5604263 0
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
351 625-3
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
560 425-7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
343 146-2
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
351 627-6
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
34009 343 147 9 7
SANOFI-AVENTIS FRANCE
FR
DE/H/0108/003
34009 5604263 0
SANOFI-AVENTIS FRANCE
FR
not available not available
UP/I-530-09/12-01/164 PA 711/29/2
FARMAL DD. ROWEX LTD
HR IE
not available not available
PA 711/29/1 PA 711/29/3
ROWEX LTD ROWEX LTD
IE IE
not available
PA 711/29/5
ROWEX LTD
IE
not available
PA 711/29/6
ROWEX LTD
IE
not available
PA 711/29/7
ROWEX LTD
IE
not available not available
1-21804 1-21810
G.L. PHARMA GMBH G.L. PHARMA GMBH
AT AT
List of nationally authorised medicinal products EMA/140794/2018
Page 101/220
Product Name (in authorisation country) Tradolan 50 mg filmdragerade tabletter Tradolan 50 mg filmuhúðaðar töflur TRADOLAN 50 mg, comprimate filmate Tradolan 50 mg/ml injektionsvätska, lösning Tradolan 50 mg-Ampullen Tradolan 50 mgFilmtabletten Tradolan Retard 100 mg depottabletter Tradolan Retard 100 mg depottabletti Tradolan retard 100 mgFilmtabletten Tradolan Retard 150 mg comprimate cu eliberare prelungita Tradolan Retard 150 mg comprimate cu eliberare prelungita Tradolan Retard 150 mg depottabletter Tradolan Retard 150 mg depottabletti Tradolan retard 150 mgFilmtabletten Tradolan Retard 200 mg comprimate cu eliberare prelungita Tradolan Retard 200 mg comprimate cu eliberare prelungita
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
13068
G.L. PHARMA GMBH
SE
not available
960128
G.L. PHARMA GMBH
IS
not available
8300/2006/01
RO
not available
13067
LANNACHER HEILMITTEL GES.M.B.H., G.L. PHARMA GMBH
not available not available
1-21802 1-21806
G.L. PHARMA GMBH G.L. PHARMA GMBH
AT AT
AT/H/0117/001
17256
G.L. PHARMA GMBH
SE
AT/H/0117/001
16503
G.L. PHARMA GMBH
FI
not available
1-21255
G.L. PHARMA GMBH
AT
not available
4765/2012/01
LANNACHER HEILMITTEL GES.M.B.H.,
RO
not available
4765/2012/02
LANNACHER HEILMITTEL GES.M.B.H.,
RO
AT/H/0117/002
17257
G.L. PHARMA GMBH
SE
AT/H/0117/002
16504
G.L. PHARMA GMBH
FI
not available
1-21254
G.L. PHARMA GMBH
AT
not available
4766/2012/01
LANNACHER HEILMITTEL GES.M.B.H.,
RO
not available
4766/2012/02
LANNACHER HEILMITTEL GES.M.B.H.,
RO
List of nationally authorised medicinal products EMA/140794/2018
SE
Page 102/220
Product Name (in authorisation country) Tradolan Retard 200 mg depottabletter Tradolan Retard 200 mg depottabletti Tradolan retard 200 mgFilmtabletten Tradolan Retard, depottabletter Tradolan Retard, depottabletter Tradolan Retard, depottabletter Tradolan, tabletter, filmovertrukne Tradolan-Tropfen Tradonal retard 100 mg cápsulas duras de liberación prolongada Tradonal retard 150 mg cápsulas duras de liberación prolongada Tradonal retard 200 mg cápsulas duras de liberación prolongada Tradonal retard 50 mg cápsulas duras de liberación prolongada TRADONAL ODIS 50 mg comprimés orodispersibles TRADONAL ODIS 50 mg comprimés orodispersibles. TRADONAL ODIS 50 mg orodispergeerbare tabletten TRADONAL ODIS 50 mg Schmelztabletten
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
AT/H/0117/003
17258
G.L. PHARMA GMBH
SE
AT/H/0117/003
16505
G.L. PHARMA GMBH
FI
not available
1-21239
G.L. PHARMA GMBH
AT
AT/H/0117/003
32518
G.L. PHARMA GMBH
DK
AT/H/0117/001
32516
G.L. PHARMA GMBH
DK
AT/H/0117/002
32517
G.L. PHARMA GMBH
DK
not available
18233
G.L. PHARMA GMBH
DK
not available UK/H/0225/002
1-21808 62.111
G.L. PHARMA GMBH MEDA PHARMA S.L.
AT ES
UK/H/0225/003
62.112
MEDA PHARMA S.L.
ES
UK/H/0225/004
62.113
MEDA PHARMA S.L.
ES
UK/H/0225/001
62.110
MEDA PHARMA S.L.
ES
UK/H/0640/001
BE267032
S.A. MEDA PHARMA N.V.
BE
UK/H/0640/001
2004/110026
S.A. MEDA PHARMA N.V.
LU
UK/H/0640/001
BE 267032
S.A. MEDA PHARMA N.V.
BE
UK/H/0640/001
BE267032
S.A. MEDA PHARMA N.V.
BE
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Page 103/220
Product Name (in authorisation country) TRADONAL ODIS 50 mg Schmelztabletten TRADONAL Retard 100 mg Hartkapseln, retardiert TRADONAL Retard 100 mg Hartkapseln, retardiert TRADONAL Retard 100 mg, capsules met verlengde afgifte, hard TRADONAL Retard 100 mg, gélules à libération prolongée TRADONAL Retard 100 mg, gélules à libération prolongée TRADONAL Retard 150 mg Hartkapseln, retardiert TRADONAL Retard 150 mg Hartkapseln, retardiert TRADONAL Retard 150 mg, capsules met verlengde afgifte, hard TRADONAL Retard 150 mg, gélules à libération prolongée TRADONAL Retard 150 mg, gélules à libération prolongée TRADONAL Retard 200 mg Hartkapseln, retardiert TRADONAL Retard 200 mg Hartkapseln, retardiert TRADONAL Retard 200 mg, capsules met verlengde afgifte, hard
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0640/001
2004/110026
S.A. MEDA PHARMA N.V.
LU
UK/H/0225/002
BE195447
S.A. MEDA PHARMA N.V.
BE
UK/H/0225/002
2011/010940
S.A. MEDA PHARMA N.V.
LU
UK/H/0225/002
BE195447
S.A. MEDA PHARMA N.V.
BE
UK/H/0225/002
BE195447
S.A. MEDA PHARMA N.V.
BE
UK/H/0225/002
2011/010940
S.A. MEDA PHARMA N.V.
LU
UK/H/0225/003
BE195456
S.A. MEDA PHARMA N.V.
BE
UK/H/0225/003
2011/010941
S.A. MEDA PHARMA N.V.
LU
UK/H/0225/003
BE195456
S.A. MEDA PHARMA N.V.
BE
UK/H/0225/003
BE195456
S.A. MEDA PHARMA N.V.
BE
UK/H/0225/003
2011/010941
S.A. MEDA PHARMA N.V.
LU
UK/H/0225/004
BE195465
S.A. MEDA PHARMA N.V.
BE
UK/H/0225/004
2011/010942
S.A. MEDA PHARMA N.V.
LU
UK/H/0225/004
BE195465
S.A. MEDA PHARMA N.V.
BE
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Page 104/220
Product Name (in authorisation country) TRADONAL Retard 200 mg, gélules à libération prolongée TRADONAL Retard 200 mg, gélules à libération prolongée TRADONAL Retard 50 mg Hartkapseln, retardiert TRADONAL Retard 50 mg Hartkapseln, retardiert TRADONAL Retard 50 mg, capsules met verlengde afgifte, hard TRADONAL Retard 50 mg, gélules à libération prolongée TRADONAL Retard 50 mg, gélules à libération prolongée Tradonal Smelt, 50 mg smelttabletten TRADONAL, 100 mg, Injektionslösung TRADONAL, 100 mg, Injektionslösung TRADONAL, 100 mg, oplossing voor injectie TRADONAL, 100 mg, solution injectable TRADONAL, 100 mg, solution injectable TRADONAL, 100 mg/ml, druppels voor oraal gebruik TRADONAL, 100 mg/ml, solution buvable en gouttes
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0225/004
BE195465
S.A. MEDA PHARMA N.V.
BE
UK/H/0225/004
2011/010942
S.A. MEDA PHARMA N.V.
LU
UK/H/0225/001
BE195377
S.A. MEDA PHARMA N.V.
BE
UK/H/0225/001
2011/010939
S.A. MEDA PHARMA N.V.
LU
UK/H/0225/001
BE195377
S.A. MEDA PHARMA N.V.
BE
UK/H/0225/001
BE195377
S.A. MEDA PHARMA N.V.
BE
UK/H/0225/001
2011/010939
S.A. MEDA PHARMA N.V.
LU
UK/H/0640/001
RVG 30752
MEDA PHARMA B.V.
NL
not available
BE 177615
S.A. MEDA PHARMA N.V.
BE
not available
2003/087561
S.A. MEDA PHARMA N.V.
LU
not available
BE177615
S.A. MEDA PHARMA N.V.
BE
not available
BE177615
S.A. MEDA PHARMA N.V.
BE
not available
2003/087561
S.A. MEDA PHARMA N.V.
LU
not available
BE177633
S.A. MEDA PHARMA N.V.
BE
not available
BE177633
S.A. MEDA PHARMA N.V.
BE
List of nationally authorised medicinal products EMA/140794/2018
Page 105/220
Product Name (in authorisation country) TRADONAL, 100 mg/ml, solution buvable en gouttes TRADONAL, 100 mg/ml, Tropfen zum Einnehmen TRADONAL, 100 mg/ml, Tropfen zum Einnehmen TRADONAL, 50 mg, capsules TRADONAL, 50 mg, gélules TRADONAL, 50 mg, gélules TRADONAL, 50 mg, Kapseln TRADONAL, 50 mg, Kapseln TRADONAL™ S.R. 100 mg Capsule TRADONAL™ S.R. 100 mg Capsule TRADONAL™ S.R. 150 mg Capsule TRADONAL™ S.R. 150 mg Capsule TRADONAL™ S.R. 200 mg Capsule TRADONAL™ S.R. 200 mg Capsule TRADONAL™ S.R. 50 mg Capsule TRADONAL™ S.R. 50 mg Capsule Tradorec XL 100 mg prolonged-release tablets Tradorec XL 200 mg prolonged-release tablets Tradorec XL 300 mg prolonged-release tablets TRAFLASH 50 mg compressa orodispersibile
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
2003/087560
S.A. MEDA PHARMA N.V.
LU
not available
BE 177633
S.A. MEDA PHARMA N.V.
BE
not available
2003/087560
S.A. MEDA PHARMA N.V.
LU
not available not available not available not available not available UK/H/0225/002
BE 177642 BE 177642 2003/087559 BE 177642 2003/087559 034233027
S.A. MEDA PHARMA N.V. S.A. MEDA PHARMA N.V. S.A. MEDA PHARMA N.V. S.A. MEDA PHARMA N.V. S.A. MEDA PHARMA N.V. MEDA PHARMA S.P.A.
BE BE LU BE LU IT
UK/H/0225/002
034233066
MEDA PHARMA S.P.A.
IT
UK/H/0225/003
034233039
MEDA PHARMA S.P.A.
IT
UK/H/0225/003
034233078
MEDA PHARMA S.P.A.
IT
UK/H/0225/004
034233041
MEDA PHARMA S.P.A.
IT
UK/H/0225/004
034233080
MEDA PHARMA S.P.A.
IT
UK/H/0225/001
034233054
MEDA PHARMA S.P.A.
IT
UK/H/0225/001
034233015
MEDA PHARMA S.P.A.
IT
FR/H/0272/001
PL 43808/0001
ENDO VENTURES LIMITED
UK
FR/H/0272/002
PL 43808/0002
ENDO VENTURES LIMITED
UK
FR/H/0272/003
PL 43808/0003
ENDO VENTURES LIMITED
UK
UK/H/0640/001
036672018
MEDA PHARMA S.P.A.
IT
List of nationally authorised medicinal products EMA/140794/2018
Page 106/220
Product Name (in authorisation country) TRAFLASH 50 mg compressa orodispersibile TRAFLASH 50 mg compressa orodispersibile TRAFLASH 50 mg compressa orodispersibile TRAFLASH 50 mg compressa orodispersibile TRAFLASH 50 mg compressa orodispersibile TRAFLASH 50 mg compressa orodispersibile TRAFLASH 50 mg compressa orodispersibile TRAFLASH 50 mg compressa orodispersibile TRALGIT 100 INJ injekční roztok tramadoli hydrochloridum TRALGIT 100 INJ injekční roztok tramadoli hydrochloridum TRALGIT 100 INJ injekční roztok tramadoli hydrochloridum TRALGIT 100 inj. injekčný roztok TRALGIT 100 inj. injekčný roztok TRALGIT 100 inj. injekčný roztok TRALGIT 50 INJ injekční roztok tramadoli hydrochloridum
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0640/001
036672020
MEDA PHARMA S.P.A.
IT
UK/H/0640/001
036672032
MEDA PHARMA S.P.A.
IT
UK/H/0640/001
036672044
MEDA PHARMA S.P.A.
IT
UK/H/0640/001
036672057
MEDA PHARMA S.P.A.
IT
UK/H/0640/001
036672069
MEDA PHARMA S.P.A.
IT
UK/H/0640/001
036672083
MEDA PHARMA S.P.A.
IT
UK/H/0640/001
036672095
MEDA PHARMA S.P.A.
IT
UK/H/0640/001
036672071
MEDA PHARMA S.P.A.
IT
not available
65/028/04-C
ZENTIVA, A.S.
CZ
not available
65/028/04-C
ZENTIVA, A.S.
CZ
not available
65/028/04-C
ZENTIVA, A.S.
CZ
not available
65/0172/03-S
ZENTIVA, A.S.
SK
not available
65/0172/03-S
ZENTIVA, A.S.
SK
not available
65/0172/03-S
ZENTIVA, A.S.
SK
not available
65/027/04-C
ZENTIVA, A.S.
CZ
List of nationally authorised medicinal products EMA/140794/2018
Page 107/220
Product Name (in authorisation country) TRALGIT 50 INJ injekční roztok tramadoli hydrochloridum TRALGIT 50 INJ injekční roztok tramadoli hydrochloridum TRALGIT 50 mg kapsuly TRALGIT 50 mg kapsuly TRALGIT gtt 100 mg/ml perorálne roztokové kvapky TRALGIT gtt 100 mg/ml perorálne roztokové kvapky TRALGIT gtt. perorální kapky, roztok TRALGIT gtt. perorální kapky, roztok TRALGIT SR 100 100 mg tablety s predĺženým uvoľňovaním TRALGIT SR 100 100 mg tablety s predĺženým uvoľňovaním TRALGIT SR 100 100 mg tablety s predĺženým uvoľňovaním TRALGIT SR 100 100 mg tablety s predĺženým uvoľňovaním TRALGIT SR 100 tablety s prodlouženým uvolňováním TRALGIT SR 100 tablety s prodlouženým uvolňováním TRALGIT SR 100 tablety s prodlouženým uvolňováním TRALGIT SR 100 tablety s prodlouženým uvolňováním
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
65/027/04-C
ZENTIVA, A.S.
CZ
not available
65/027/04-C
ZENTIVA, A.S.
CZ
not available not available not available
65/0169/03-S 65/0169/03-S 65/0170/03-S
ZENTIVA, A.S. ZENTIVA, A.S. ZENTIVA, A.S.
SK SK SK
not available
65/0170/03-S
ZENTIVA, A.S.
SK
not available
65/195/03-C
ZENTIVA, A.S.
CZ
not available
65/195/03-C
ZENTIVA, A.S.
CZ
not available
65/0258/02-S
ZENTIVA, A.S.
SK
not available
65/0258/02-S
ZENTIVA, A.S.
SK
not available
65/0258/02-S
ZENTIVA, A.S.
SK
not available
65/0258/02-S
ZENTIVA, A.S.
SK
not available
65/357/01-C
ZENTIVA, A.S.
CZ
not available
65/357/01-C
ZENTIVA, A.S.
CZ
not available
65/357/01-C
ZENTIVA, A.S.
CZ
not available
65/357/01-C
ZENTIVA, A.S.
CZ
List of nationally authorised medicinal products EMA/140794/2018
Page 108/220
Product Name (in authorisation country) TRALGIT SR 150 150 mg tablety s predĺženým uvoľňovaním TRALGIT SR 150 150 mg tablety s predĺženým uvoľňovaním TRALGIT SR 150 150 mg tablety s predĺženým uvoľňovaním TRALGIT SR 150 150 mg tablety s predĺženým uvoľňovaním TRALGIT SR 150 tablety s prodlouženým uvolňováním TRALGIT SR 150 tablety s prodlouženým uvolňováním TRALGIT SR 150 tablety s prodlouženým uvolňováním TRALGIT SR 150 tablety s prodlouženým uvolňováním TRALGIT SR 200 200 mg tablety s predĺženým uvoľňovaním TRALGIT SR 200 200 mg tablety s predĺženým uvoľňovaním TRALGIT SR 200 200 mg tablety s predĺženým uvoľňovaním TRALGIT SR 200 200 mg tablety s predĺženým uvoľňovaním TRALGIT SR 200 tablety s prodlouženým uvolňováním TRALGIT SR 200 tablety s prodlouženým uvolňováním
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
65/0259/02-S
ZENTIVA, A.S.
SK
not available
65/0259/02-S
ZENTIVA, A.S.
SK
not available
65/0259/02-S
ZENTIVA, A.S.
SK
not available
65/0259/02-S
ZENTIVA, A.S.
SK
not available
65/048/03-C
ZENTIVA, A.S.
CZ
not available
65/048/03-C
ZENTIVA, A.S.
CZ
not available
65/048/03-C
ZENTIVA, A.S.
CZ
not available
65/048/03-C
ZENTIVA, A.S.
CZ
not available
65/0260/02-S
ZENTIVA, A.S.
SK
not available
65/0260/02-S
ZENTIVA, A.S.
SK
not available
65/0260/02-S
ZENTIVA, A.S.
SK
not available
65/0260/02-S
ZENTIVA, A.S.
SK
not available
65/049/03-C
ZENTIVA, A.S.
CZ
not available
65/049/03-C
ZENTIVA, A.S.
CZ
List of nationally authorised medicinal products EMA/140794/2018
Page 109/220
Product Name (in authorisation country) TRALGIT SR 200 tablety s prodlouženým uvolňováním TRALGIT SR 200 tablety s prodlouženým uvolňováním Tralodie® 100 mg Capsule rigide a rilascio prolungato Tralodie® 100 mg Capsule rigide a rilascio prolungato Tralodie® 100 mg Capsule rigide a rilascio prolungato Tralodie® 100 mg Capsule rigide a rilascio prolungato Tralodie® 150 mg Capsule rigide a rilascio prolungato Tralodie® 150 mg Capsule rigide a rilascio prolungato Tralodie® 150 mg Capsule rigide a rilascio prolungato Tralodie® 150 mg Capsule rigide a rilascio prolungato Tralodie® 200 mg Capsule rigide a rilascio prolungato Tralodie® 200 mg Capsule rigide a rilascio prolungato Tralodie® 200 mg Capsule rigide a rilascio prolungato Tralodie® 200 mg Capsule rigide a rilascio prolungato Tramabene - Tropfen
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
65/049/03-C
ZENTIVA, A.S.
CZ
not available
65/049/03-C
ZENTIVA, A.S.
CZ
FI/H/0164/001
035986013
IT
FI/H/0164/001
035986025
FI/H/0164/001
035986037
FI/H/0164/001
035986049
FI/H/0164/002
035986052
FI/H/0164/002
035986064
FI/H/0164/002
035986076
FI/H/0164/002
035986088
FI/H/0164/003
035986090
FI/H/0164/003
035986102
FI/H/0164/003
035986114
FI/H/0164/003
035986126
not available
1-21799
Tramabene 100 mg Ampullen
not available
1-21797
THERABEL GIENNE PHARMA S.P.A. THERABEL GIENNE PHARMA S.P.A. THERABEL GIENNE PHARMA S.P.A. THERABEL GIENNE PHARMA S.P.A. THERABEL GIENNE PHARMA S.P.A. THERABEL GIENNE PHARMA S.P.A. THERABEL GIENNE PHARMA S.P.A. THERABEL GIENNE PHARMA S.P.A. THERABEL GIENNE PHARMA S.P.A. THERABEL GIENNE PHARMA S.P.A. THERABEL GIENNE PHARMA S.P.A. THERABEL GIENNE PHARMA S.P.A. RATIOPHARM ARZNEIMITTEL VERTRIEBSGMBH RATIOPHARM ARZNEIMITTEL VERTRIEBSGMBH
List of nationally authorised medicinal products EMA/140794/2018
IT IT IT IT IT IT IT IT IT IT IT AT AT
Page 110/220
Product Name (in authorisation country) Tramabene 100 mg – Retardtabletten
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
1-23913
AT
Tramabene 150 mg Retardtabletten
NL/H/0892/002
1-27076
Tramabene 150 mg Retardtabletten
NL/H/0892/002
1-27076
Tramabene 200 mg Retardtabletten
NL/H/0892/003
1-27077
Tramabene 200 mg Retardtabletten
NL/H/0892/003
1-27077
Tramabene 50 mg Ampullen
not available
1-21796
Tramabene 50 mg - Kapseln
not available
1-21798
Tramabene 50 mg kapsuly TRAMABENE 50 tobolky TRAMABENE kapky Tramabene Perorálne kvapky Tramabeta
not not not not
65/0224/98-S 65/156/99-C 65/155/99-C 65/0120/99-S
RATIOPHARM ARZNEIMITTEL VERTRIEBSGMBH RATIOPHARM ARZNEIMITTEL VERTRIEBSGMBH RATIOPHARM ARZNEIMITTEL VERTRIEBSGMBH RATIOPHARM ARZNEIMITTEL VERTRIEBSGMBH RATIOPHARM ARZNEIMITTEL VERTRIEBSGMBH RATIOPHARM ARZNEIMITTEL VERTRIEBSGMBH RATIOPHARM ARZNEIMITTEL VERTRIEBSGMBH RATIOPHARM GMBH RATIOPHARM GMBH RATIOPHARM GMBH RATIOPHARM GMBH
2125528
25528.00.00
ARZNEIMITTEL
DE
Tramabeta long 100 mg
2144604
44604.00.00
ARZNEIMITTEL
DE
Tramabeta long 150 mg
2144605
44604.01.00
ARZNEIMITTEL
DE
Tramabeta long 200 mg
2144606
44604.02.00
ARZNEIMITTEL
DE
Tram-ac 50 mg
DE/H/0144/001
37203.00.00
BETAPHARM GMBH BETAPHARM GMBH BETAPHARM GMBH BETAPHARM GMBH HEXAL AG
available available available available
List of nationally authorised medicinal products EMA/140794/2018
AT AT AT AT AT AT SK CZ CZ SK
DE
Page 111/220
Product Name (in authorisation country) Tramadex 50 mg Capsules
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
19207
CY
Tramadin 50 mg kapseli, kova Tramadin 50 mg kapseli, kova TRAMADOL TRAMADOL MEDA 50mg CÁPSULAS Tramadol ”Actavis”, kapsler, hårde Tramadol ”Aurobindo”, hårde kapsler Tramadol ”Vitabalans”, tabletter Tramadol 100 injekt - 1APharma® TRAMADOL 100 mg comprimate cu eliberare prelungita Tramadol 100 mg/ml oral drops, solution. TRAMADOL 100 MGROTEXMEDICA TRAMADOL 100 MGROTEXMEDICA TRAMADOL 100 MGROTEXMEDICA TRAMADOL 100 MGROTEXMEDICA Tramadol 100 ret - 1A Pharma® Tramadol 150 ret - 1A Pharma® Tramadol 1A Pharma 100 mg/ml - Tropfen
not available
12346
DELORBIS PHARMACEUTICALS LTD RATIOPHARM GMBH
not available
12346
RATIOPHARM GMBH
FI
not available not available
5495/2005/01 2830982
RO PT
UK/H/0380/001
31829
KRKA, D.D., NOVO MESTO MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A. ACTAVIS GROUP PTC EHF.
NL/H/2480/001
49659
DK
FI/H/0779/001
49370
AUROBINDO PHARMA (MALTA) LIMITED VITABALANS OY
not available
32751.00.00
1 A PHARMA GMBH
DE
not available
4146/2011/01
KRKA, D.D., NOVO MESTO
RO
UK/H/5154/001
PL 12762/0453
UK
not available
38543.00.00
not available
38543.00.00
not available
38543.00.00
not available
38543.00.00
not available
49470.00.00
MERCURY PHARMACEUTICALS LTD. ROTEXMEDICA GMBH ARZNEIMITTELWERK ROTEXMEDICA GMBH ARZNEIMITTELWERK ROTEXMEDICA GMBH ARZNEIMITTELWERK ROTEXMEDICA GMBH ARZNEIMITTELWERK 1 A PHARMA GMBH
not available
49470.01.00
1 A PHARMA GMBH
DE
not available
1-24618
1A PHARMA GMBH
AT
List of nationally authorised medicinal products EMA/140794/2018
FI
DK
DK
DE DE DE DE DE
Page 112/220
Product Name (in authorisation country) Tramadol 1A Pharma 50 mg - Kapseln Tramadol 200 ret - 1A Pharma® Tramadol 50 Heumann
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
1-24617
1A PHARMA GMBH
AT
not available
49470.02.00
1 A PHARMA GMBH
DE
-
25538.00.00
DE
Tramadol 50 Kapseln - 1APharma, Hartkapseln Tramadol 50 mg Capsules
not available
32751.00.02
HEUMANN PHARMA GMBH & CO. GENERICA KG 1 A PHARMA GMBH
not available
PL 17907/0110
UK
Tramadol 50 mg Capsules
UK/H/5829/001
PL 33414/0127
Tramadol 50 mg capsules, hard TRAMADOL 50 MGROTEXMEDICA TRAMADOL 50 MGROTEXMEDICA Tramadol 50 tabs - 1 A Pharma, Tabletten Tramadol 50mg Capsules Tramadol 50mg Capsules Tramadol 50mg Capsules Tramadol 50mg/ml Solution for Injection or Infusion Tramadol AbZ 100 mg Retardkapseln Tramadol AbZ 100 mg/ml Tropfen Tropfen zum Einnehmen, Lösung Tramadol AbZ 150 mg Retardkapseln Tramadol AbZ 200 mg Retardkapseln Tramadol AbZ 50 mg/ml Injektionslösung
NL/H/2480/001
PL 16363/0335
BRISTOL LABORATORIES LTD (BERKHAMSTED) CHELONIA HEALTHCARE LIMITED MILPHARM LIMITED
not available
38449.00.00
DE
not available
38449.00.00
not available
30798.00.00
ROTEXMEDICA GMBH ARZNEIMITTELWERK ROTEXMEDICA GMBH ARZNEIMITTELWERK 1 A PHARMA GMBH
UK/H/0953/001 UK/H/0953/001 not available not available
PA1128/003/001 PL 20395 / 0065 PL 00289/1603 PL 18157/0014
IE UK UK UK
not available
54390.01.00
RELON CHEM LIMITED RELON CHEM LIMITED TEVA UK LIMITED BEACON PHARMACEUTICALS LIMITED ABZ-PHARMA GMBH
not available
31518.00.01
ABZ-PHARMA GMBH
DE
not available
62758.01.00
ABZ-PHARMA GMBH
DE
not available
62758.02.00
ABZ-PHARMA GMBH
DE
not available
32307.00.00
ABZ-PHARMA GMBH
DE
List of nationally authorised medicinal products EMA/140794/2018
DE
UK UK
DE DE
DE
Page 113/220
Product Name (in authorisation country) Tramadol acis Tropfen Tramadol actas 100 mg Retardtabletten Tramadol actas 150 mg Retardtabletten Tramadol actas 200 mg Retardtabletten Tramadol Actavis TRAMADOL ACTAVIS 100 MG/ML BELSŐLEGES OLDATOS CSEPPEK Tramadol Actavis 50 mg harde kapsler Tramadol Actavis 50 mg hylki, hörð Tramadol Actavis 50 mg kapslar, hårda Tramadol Actavis 50 mg kemény kapszula TRAMADOL ACTAVIS 50 mg, gélule Tramadol Actavis 50 mg/ml oldatos injekció Tramadol Actavis 50mg capsules, hard Tramadol AL 100 Ampullen Tramadol AL 100 mg Retardtabletten Tramadol AL 150 mg Retardtabletten Tramadol AL 200 mg Retardtabletten Tramadol AL 50 Brausetabletten Tramadol AL 50 Kapseln
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available not available
35169.00.00 49469.00.00
DE DE
not available
49469.01.00
not available
49469.02.00
FR/H/0403/001/DC not available
IS/1/09/064/01 OGYI-T-7724/01
ACIS ARZNEIMITTEL GMBH ARISTO PHARMA GMBH (ART 57) ARISTO PHARMA GMBH (ART 57) ARISTO PHARMA GMBH (ART 57) ACTAVIS GROUP PTC EHF. ACTAVIS GROUP PTC EHF.
FR/H/0403/001
09-6559
ACTAVIS GROUP PTC EHF.
NO
FR/H/0403/001
IS/1/09/064/01
ACTAVIS GROUP PTC EHF.
IS
UK/H/0380/001
16600
ACTAVIS GROUP PTC EHF.
SE
OGYI-T-7724/05-07
OGYI-T-7724/05-07
ACTAVIS GROUP PTC EHF.
HU
FR/H/0403/001
NL 37429
ACTAVIS GROUP PTC EHF.
FR
OGYI-T-7724/03-04
OGYI-T-7724/03-04
ACTAVIS GROUP PTC EHF.
HU
FR/H/0403/001
09-6559
ACTAVIS GROUP PTC EHF.
NO
not available AT/H/0118/001
30903.00.00 53804.00.00
ALIUD PHARMA GMBH ALIUD PHARMA GMBH
DE DE
AT/H/0118/002
53804.01.00
ALIUD PHARMA GMBH
DE
AT/H/0118/003
53804.02.00
ALIUD PHARMA GMBH
DE
not available
37019.00.00
ALIUD PHARMA GMBH
DE
not available
30903.00.02
ALIUD PHARMA GMBH
DE
List of nationally authorised medicinal products EMA/140794/2018
DE DE IS HU
Page 114/220
Product Name (in authorisation country) Tramadol AL 50 mg kemény kapszula Tramadol AL 50 mg kemény kapszula Tramadol AL 50 mg kemény kapszula Tramadol AL Tropfen Tramadol Arcana 100 mg Retardtabletten Tramadol Arcana 150 mg Retardtabletten Tramadol Arcana 200 mg Retardtabletten TRAMADOL ARENA 50 mg capsule Tramadol Arena 50 mg capsule Tramadol Aristo 150 mg comprimidos de liberación prolongada EFG Tramadol Aristo 200 mg comprimidos de liberación prolongada EFG TRAMADOL ARISTO 50 mg cápsulas E.F.G. Tramadol Aristo® 100 mg Retardtabletten Tramadol Aristo® 150 mg Retardtabletten Tramadol Aristo® 200 mg Retardtabletten Tramadol Aristo100 mg comprimidos de liberación prolongada EFG TRAMADOL ARROW 50 mg, comprimé
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
OGYI-T-7869/03
ALIUD PHARMA GMBH
HU
not available
OGYI-T-7869/02
ALIUD PHARMA GMBH
HU
not available
OGYI-T-7869/01
ALIUD PHARMA GMBH
HU
not available UK/H/4160/001
30903.00.01 1-31515
DE AT
UK/H/4160/002
1-31516
UK/H/4160/003
1-31517
not available
9254/2016/02
ALIUD PHARMA GMBH ARCANA ARZNEIMITTEL GMBH ARCANA ARZNEIMITTEL GMBH ARCANA ARZNEIMITTEL GMBH ARENA GROUP S.A
not available
9254/2016/01
ARENA GROUP S.A
RO
not available
65834
ARISTO PHARMA IBERIA, S.L.
ES
not available
65835
ARISTO PHARMA IBERIA, S.L.
ES
not available
63.451
IBERIA,
ES
not available
50307.00.00
GMBH
DE
not available
50307.01.00
GMBH
DE
not available
50307.02.00
GMBH
DE
not available
65833
ARISTO PHARMA S.L. ARISTO PHARMA (ART 57) ARISTO PHARMA (ART 57) ARISTO PHARMA (ART 57) ARISTO PHARMA S.L.
IBERIA,
ES
not available
26860
List of nationally authorised medicinal products EMA/140794/2018
ARROW GENERIQUES
AT AT RO
FR
Page 115/220
Product Name (in authorisation country) TRAMADOL ARROW L.P. 100 mg, comprimé à libération prolongée TRAMADOL ARROW L.P. 100 mg, gélule à libération prolongée TRAMADOL ARROW L.P. 150 mg, comprimé à libération prolongée TRAMADOL ARROW L.P. 150 mg, gélule à libération prolongée TRAMADOL ARROW L.P. 200 mg, comprimé à libération prolongée TRAMADOL ARROW L.P. 200 mg, gélule à libération prolongée TRAMADOL ASTA Medica 100 mg Solución Inyectable EFG TRAMADOL ASTA Medica EFG Cápsulas TRAMADOL ASTA Medica Gotas EFG Tramadol Aurobindo 50 mg cápsulas duras EFG Tramadol Aurobindo 50 mg capsules, hard Tramadol Aurobindo 50 mg kapslar, hårda Tramadol Aurobindo, 50 mg, kapsułki, twarde Tramadol Aurovitas 100 mg comprimidos de libertação prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
NL 36433
ARROW GENERIQUES
FR
not available
32723
ARROW GENERIQUES
FR
not available
NL 36434
ARROW GENERIQUES
FR
not available
32724
ARROW GENERIQUES
FR
not available
NL 36435
ARROW GENERIQUES
FR
not available
32725
ARROW GENERIQUES
FR
not available
63.465
MEDA PHARMA S.L.
ES
not available
61.849
MEDA PHARMA S.L.
ES
not available
62.925
MEDA PHARMA S.L.
ES
NL/H/2480/001
77.656
ES
NL/H/2480/001
MA807/05401
NL/H/2480/001
46985
NL/H/2480/001
20928
NL/H/0890/001
5032024
LABORATORIOS AUROBINDO S.L.U. AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROBINDO PHARMA (MALTA) LIMITED AUROVITAS UNIPESSOAL, LDA.
List of nationally authorised medicinal products EMA/140794/2018
MT SE PL PT
Page 116/220
Product Name (in authorisation country) Tramadol Aurovitas 150 mg comprimidos de libertação prolongada Tramadol Aurovitas 200 mg comprimidos de libertação prolongada Tramadol Aurovitas 50 mg cápsulas duras EFG Tramadol Aurovitas 50 mg tvrdé tobolky Tramadol Aurovitas 50 mg/ml solução injetável ou para perfusão Tramadol Aurovitas 50 mg/ml solução injetável ou para perfusão Tramadol Aurovitas 50 mg/ml solução injetável ou para perfusão Tramadol Aurovitas 50 mg/ml solução injetável ou para perfusão Tramadol Aurovitas 50 mg/ml solução injetável ou para perfusão Tramadol Aurovitas 50 mg/ml solução injetável ou para perfusão Tramadol Aurovitas 50 mg/ml solução injetável ou para perfusão Tramadol Aurovitas 50 mg/ml solução injetável ou para perfusão Tramadol Aurovitas 50 mg/ml solução injetável ou para perfusão
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0890/002
5032057
AUROVITAS UNIPESSOAL, LDA.
PT
NL/H/0890/003
5032107
AUROVITAS UNIPESSOAL, LDA.
PT
PT/H/1576/001
81.624
AUROVITAS SPAIN,S.A.U.
ES
PT/H/1576/001
65/806/15-C
CZ
PT/H/1548/001
PT/H/1548/001
AUROVITAS UNIPESSOAL, LDA. AUROVITAS UNIPESSOAL, LDA.
PT/H/1548/001
PT/H/1548/001
AUROVITAS UNIPESSOAL, LDA.
PT
PT/H/1548/001
PT/H/1548/001
AUROVITAS UNIPESSOAL, LDA.
PT
PT/H/1548/001
PT/H/1548/001
AUROVITAS UNIPESSOAL, LDA.
PT
PT/H/1548/001
PT/H/1548/001
AUROVITAS UNIPESSOAL, LDA.
PT
PT/H/1548/001
PT/H/1548/001
AUROVITAS UNIPESSOAL, LDA.
PT
PT/H/1548/001
5703368
AUROVITAS UNIPESSOAL, LDA.
PT
PT/H/1548/001
PT/H/1548/001
AUROVITAS UNIPESSOAL, LDA.
PT
PT/H/1548/001
PT/H/1548/001
AUROVITAS UNIPESSOAL, LDA.
PT
List of nationally authorised medicinal products EMA/140794/2018
PT
Page 117/220
Product Name (in authorisation country) Tramadol Aurovitas 50 mg/ml solução injetável ou para perfusão Tramadol Aurovitas 50 mg/ml solução injetável ou para perfusão Tramadol Aurovitas 50 mg/ml solução injetável ou para perfusão Tramadol Aurovitas 50 mg/ml solución inyectable y para perfusión EFG Tramadol axcount 100 mg retard, Retardtabletten Tramadol axcount 150 mg retard, Retardtabletten Tramadol axcount 200 mg retard, Retardtabletten Tramadol axcount 50 mg Brausetabletten Tramadol axcount Tropfen, Lösung zum Einnehmen Tramadol Azevedos 50 mg cápsulas
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PT/H/1548/001
5703376
AUROVITAS UNIPESSOAL, LDA.
PT
PT/H/1548/001
PT/H/1548/001
AUROVITAS UNIPESSOAL, LDA.
PT
PT/H/1548/001
PT/H/1548/001
AUROVITAS UNIPESSOAL, LDA.
PT
PT/H/1548/001
81.910
AUROVITAS SPAIN,S.A.U.
ES
not available
50310.00.00
AXCOUNT GENERIKA GMBH
DE
not available
50310.01.00
AXCOUNT GENERIKA GMBH
DE
not available
50310.02.00
AXCOUNT GENERIKA GMBH
DE
not available
37018.00.00
AXCOUNT GENERIKA GMBH
DE
not available
35164.00.00
AXCOUNT GENERIKA GMBH
DE
not available
5012273
PT
Tramadol Azevedos 50 mg cápsulas
not available
5012307
Tramadol Azevedos 50 mg cápsulas
not available
5012315
Tramadol Azevedos 50 mg cápsulas
not available
5012331
LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A.
List of nationally authorised medicinal products EMA/140794/2018
PT PT PT
Page 118/220
Product Name (in authorisation country) Tramadol Azevedos 50 mg cápsulas
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
5012349
PT
Tramadol Azevedos 50 mg cápsulas
not available
5012356
Tramadol Azevedos 50 mg cápsulas
not available
5012323
Tramadol Azevedos 50 mg cápsulas
not available
5012265
Tramadol Basi, 100 mg/2 ml Solução Injectável
not available
497 87 97
Tramadol Basi, 100 mg/2 ml Solução Injectável
not available
324 25 91
Tramadol Basi, 50 mg/1 ml Solução Injectável
not available
497 86 98
Tramadol Basi, 50 mg/1 ml Solução Injectável
not available
324 27 99
TRAMADOL BIOGARAN mg, gélule TRAMADOL BIOGARAN mg, gélule TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée
50
not available
3400935248442
LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS AZEVEDOS - INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS BASI – INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS BASI – INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS BASI – INDÚSTRIA FARMACÊUTICA, S.A. LABORATÓRIOS BASI – INDÚSTRIA FARMACÊUTICA, S.A. BIOGARAN
50
not available
3400935248442
BIOGARAN
FR
LP
DE/H/0798/002
34009 300 141 0 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/002
34009 550 049 5 0
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/002
34009 382 128 1 5
LABORATOIRES GRÜNENTHAL S.A.S.
FR
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PT PT PT PT PT PT PT FR
Page 119/220
Product Name (in authorisation country) TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
LP
DE/H/0798/002
34009 382 125 2 5
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/002
34009 382 129 8 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/002
34009 382 121 7 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/002
34009 382 130 6 5
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/002
34009 571 534 7 2
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/002
34009 382 127 5 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/002
34009 382 131 2 6
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/002
34009 382 122 3 5
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/002
34009 382 120 0 6
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/002
34009 382 124 6 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/002
34009 382 132 9 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/002
34009 571 533 0 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 120/220
Product Name (in authorisation country) TRAMADOL BIOGARAN 100 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
LP
DE/H/0798/002
34009 382 126 9 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/003
34009 300 141 1 0
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/003
34009 550 049 6 7
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/003
34009 382 223 4 0
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/003
34009 382 225 7 9
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/003
34009 382 228 6 9
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/003
34009 382 220 5 0
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/003
34009 382 230 0 2
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/003
34009 382 229 2 0
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/003
34009 382 222 8 9
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/003
34009 571 539 9 1
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/003
34009 382 231 7 0
LABORATOIRES GRÜNENTHAL S.A.S.
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 121/220
Product Name (in authorisation country) TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 150 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 200 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 200 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 200 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 200 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 200 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 200 mg, comprimé à libération prolongée TRAMADOL BIOGARAN 200 mg, comprimé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
LP
DE/H/0798/003
34009 382 224 0 1
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/003
34009 571 538 2 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/003
34009 382 226 3 0
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/003
34009 382 221 1 1
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/003
34009 382 232 3 1
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/004
34009 300 141 2 7
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/004
34009 550 049 7 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/004
34009 382 259 9 0
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/004
34009 382 258 2 2
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/004
34009 382 243 5 1
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/004
34009 382 241 2 2
LABORATOIRES GRÜNENTHAL S.A.S.
FR
LP
DE/H/0798/004
34009 382 247 0 2
LABORATOIRES GRÜNENTHAL S.A.S.
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 122/220
Product Name (in authorisation country) TRAMADOL BIOGARAN LP 200 mg, comprimé à libération prolongée TRAMADOL BIOGARAN LP 200 mg, comprimé à libération prolongée TRAMADOL BIOGARAN LP 200 mg, comprimé à libération prolongée TRAMADOL BIOGARAN LP 200 mg, comprimé à libération prolongée TRAMADOL BIOGARAN LP 200 mg, comprimé à libération prolongée TRAMADOL BIOGARAN LP 200 mg, comprimé à libération prolongée TRAMADOL BIOGARAN LP 200 mg, comprimé à libération prolongée TRAMADOL BIOGARAN LP 200 mg, comprimé à libération prolongée TRAMADOL BIOGARAN LP 200 mg, comprimé à libération prolongée Tramadol Ciclum 100 mg/ml solução oral Tramadol Ciclum 100 mg/ml solução oral Tramadol Ciclum 100 mg/ml solução oral Tramadol Ciclum 50 mg cápsulas
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0798/004
34009 382 257 6 1
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/0798/004
34009 382 249 3 1
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/0798/004
34009 382 253 0 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/0798/004
34009 382 248 7 0
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/0798/004
34009 571 540 7 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/0798/004
34009 571 541 3 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/0798/004
34009 382 245 8 0
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/0798/004
34009 382 254 7 1
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/0798/004
34009 382 255 3 2
LABORATOIRES GRÜNENTHAL S.A.S.
FR
not available
2668986
PT
not available
2709988
not available
3081387
not available
2679686
CICLUM FARMA UNIPESSOAL LDA. CICLUM FARMA UNIPESSOAL LDA. CICLUM FARMA UNIPESSOAL LDA. CICLUM FARMA UNIPESSOAL LDA.
List of nationally authorised medicinal products EMA/140794/2018
PT PT PT
Page 123/220
Product Name (in authorisation country) Tramadol Ciclum 50 mg cápsulas tramadol cinfa 50 mg cápsulas duras EFG TRAMADOL CRISTERS LP 100 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 100 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 100 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 100 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 100 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 100 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 150 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 150 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 150 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 150 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 150 mg, comprimé pelliculé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
2679587
PT
not available
63.440
CICLUM FARMA UNIPESSOAL LDA. LABORATORIOS CINFA, S.A.
not available
34009 493 635 9 9
CRISTERS
FR
not available
34009 493 636 5 0
CRISTERS
FR
not available
34009 493 637 1 1
CRISTERS
FR
not available
34009 493 635 9 9
CRISTERS
FR
not available
34009 493 636 5 0
CRISTERS
FR
not available
34009 493 637 1 1
CRISTERS
FR
not available
34009 493 638 8 9
CRISTERS
FR
not available
34009 493 639 4 0
CRISTERS
FR
not available
34009 493 640 2 2
CRISTERS
FR
not available
34009 493 641 9 0
CRISTERS
FR
not available
34009 578 149 1 5
CRISTERS
FR
List of nationally authorised medicinal products EMA/140794/2018
ES
Page 124/220
Product Name (in authorisation country) TRAMADOL CRISTERS LP 150 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 150 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 150 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 150 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 150 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 150 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 150 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 200 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 200 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 200 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 200 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 200 mg, comprimé pelliculé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
34009 578 151 6 5
CRISTERS
FR
not available
34009 493 638 8 9
CRISTERS
FR
not available
34009 493 639 4 0
CRISTERS
FR
not available
34009 493 640 2 2
CRISTERS
FR
not available
34009 493 641 9 0
CRISTERS
FR
not available
34009 578 149 1 5
CRISTERS
FR
not available
34009 578 151 6 5
CRISTERS
FR
not available
34009 493 785 0 0
CRISTERS
FR
not available
34009 493 786 7 8
CRISTERS
FR
not available
34009 493 787 3 9
CRISTERS
FR
not available
34009 493 789 6 8
CRISTERS
FR
not available
34009 578 169 2 6
CRISTERS
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 125/220
Product Name (in authorisation country) TRAMADOL CRISTERS LP 200 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 200 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 200 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 200 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 200 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 200 mg, comprimé pelliculé à libération prolongée TRAMADOL CRISTERS LP 200 mg, comprimé pelliculé à libération prolongée Tramadol Denk 100 mg Injektionslösung Tramadol Denk 50 mg Brause Tramadol Denk 50 mg Brause Tramadol Dermogen 50 mg cápsulas duras EFG Tramadol EG 100 mg/2 ml Injektionslösung Tramadol EG 100 mg/2 ml oplossing voor injectie Tramadol EG 100 mg/2ml solution injectable
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
34009 578 170 0 8
CRISTERS
FR
not available
34009 493 785 0 0
CRISTERS
FR
not available
34009 493 786 7 8
CRISTERS
FR
not available
34009 493 787 3 9
CRISTERS
FR
not available
34009 493 789 6 8
CRISTERS
FR
not available
34009 578 169 2 6
CRISTERS
FR
not available
34009 578 170 0 8
CRISTERS
FR
not available
38542.00.00
DE
not available
34728.00.00
not available
34728.00.00
not available
65724
DENK PHARMA GMBH & CO. KG DENK PHARMA GMBH & CO. KG DENK PHARMA GMBH & CO. KG DERMOGEN FARMA, S.A.
DE/H/0282/004
BE245786
EUROGENERICS N.V./S.A.
BE
DE/H/0282/004
BE245786
EUROGENERICS N.V./S.A.
BE
DE/H/0282/004
BE245786
EUROGENERICS N.V./S.A.
BE
List of nationally authorised medicinal products EMA/140794/2018
DE DE ES
Page 126/220
Product Name (in authorisation country) Tramadol EG 100 mg/2ml solution injectable Tramadol EG 100 mg/ml druppels voor oraal gebruik, oplossing Tramadol EG 100 mg/ml solution buvable en gouttes Tramadol EG 100 mg/ml solution buvable en gouttes Tramadol EG 100 mg/ml Tropfen zum Einnehmen, Lösung Tramadol EG 50 mg Brausetabletten Tramadol EG 50 mg bruistabletten Tramadol EG 50 mg comprimés Tramadol EG 50 mg comprimés effervescents Tramadol EG 50 mg tabletten Tramadol EG 50 mg Tabletten TRAMADOL EG 50 mg, comprimé TRAMADOL EG L.P. 100 mg, comprimé à libération prolongée TRAMADOL EG L.P. 150 mg, comprimé à libération prolongée TRAMADOL EG L.P. 200 mg, comprimé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0282/004
0019/08039713
EUROGENERICS N.V./S.A.
LU
DE/H/0282/002
BE245707
EUROGENERICS N.V./S.A.
BE
DE/H/0282/002
BE245707
EUROGENERICS N.V./S.A.
BE
DE/H/0282/002
0019/08039712
EUROGENERICS N.V./S.A.
LU
DE/H/0282/002
BE245707
EUROGENERICS N.V./S.A.
BE
not available
BE232802
EUROGENERICS N.V./S.A.
BE
not available
BE232802
EUROGENERICS N.V./S.A.
BE
UK/H/0305/001
BE216474
EUROGENERICS N.V./S.A.
BE
not available
BE232802
EUROGENERICS N.V./S.A.
BE
UK/H/0305/001
BE216474
EUROGENERICS N.V./S.A.
BE
UK/H/0305/001
BE216474
EUROGENERICS N.V./S.A.
BE
not available
NL24562
FR
not available
NL37921
EG LABO - LABORATOIRES EUROGENERICS EG LABO - LABORATOIRES EUROGENERICS
not available
NL37922
EG LABO - LABORATOIRES EUROGENERICS
FR
not available
NL37923
EG LABO - LABORATOIRES EUROGENERICS
FR
List of nationally authorised medicinal products EMA/140794/2018
FR
Page 127/220
Product Name (in authorisation country) TRAMADOL ETHYPHARM 100 mg, Hartkapsel, retardiert TRAMADOL ETHYPHARM 150 mg, Hartkapsel, retardiert Tramadol Ethypharm 200mg, Hartkapsel, retardiert TRAMADOL ETHYPHARM 50 mg, Hartkapsel, retardiert TRAMADOL EVOLUGEN 50 mg, gélule TRAMADOL EVOLUGEN 50 mg, gélule TRAMADOL EVOLUGEN 50 mg, gélule TRAMADOL EVOLUGEN 50 mg, gélule TRAMADOL EVOLUGEN 50 mg, gélule Tramadol Farmal 100 mg tablete s produljenim oslobađanjem Tramadol Farmal 150 mg tablete s produljenim oslobaðanjem Tramadol Farmal 200 mg tablete s produljenim oslobaðanjem TRAMADOL FARMALIDER 100 mg/ml, solución oral .E.F.G Tramadol Generis 100 mg/ml solução oral Tramadol Generis 100 mg/ml solução oral
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0639/002
54160.01.00
ETHYPHARM
DE
DE/H/0639/003
54160.02.00
ETHYPHARM
DE
DE/H/0639/004
54160.03.00
ETHYPHARM
DE
DE/H/0639/001
54160.00.00
ETHYPHARM
DE
not available
34009 266 909 0 8
EVOLUPHARM
FR
not available
34009 266 907 8 6
EVOLUPHARM
FR
not available
34009 266 908 4 7
EVOLUPHARM
FR
not available
34009 266 910 9 7
EVOLUPHARM
FR
not available
34009 583 516 9 3
EVOLUPHARM
FR
not available
HR-H-671676641
FARMAL DD.
HR
not available
HR-H-918620020
FARMAL DD.
HR
not available
HR-H-086392384
FARMAL DD.
HR
not available
69404
FARMALIDER, S.A.
ES
not available
3759396
PT
not available
5598990
GENERIS FARMACÊUTICA, S.A. GENERIS FARMACÊUTICA, S.A.
List of nationally authorised medicinal products EMA/140794/2018
PT
Page 128/220
Product Name (in authorisation country) Tramadol Generis Phar 50 mg, cápsulas Tramadol Generis Phar 50 mg, cápsulas Tramadol Generis, 100 mg/2 ml, solução injectável Tramadol Generis, 100 mg/2 ml, solução injectável Tramadol HCl 100 mg/ml PCH, druppels voor oraal gebruik Tramadol HCl Actavis Retard 100 mg, tabletten met gereguleerde afgifte Tramadol HCl Actavis Retard 100 mg, tabletten met gereguleerde afgifte Tramadol HCl Actavis Retard 150 mg, tabletten met gereguleerde afgifte Tramadol HCl Actavis Retard 150 mg, tabletten met gereguleerde afgifte Tramadol HCl Actavis Retard 200 mg, tabletten met gereguleerde afgifte Tramadol HCl Actavis Retard 200 mg, tabletten met gereguleerde afgifte Tramadol HCl Apotex 50 mg, capsules Tramadol HCl Aurobindo 50 mg, capsules, hard Tramadol HCl bruis 50 PCH, bruistabletten 50 mg
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
3759495
PT
not available
3759594
not available
3759198
not available
3759297
not available
RVG 27177
GENERIS FARMACÊUTICA, S.A. GENERIS FARMACÊUTICA, S.A. GENERIS FARMACÊUTICA, S.A. GENERIS FARMACÊUTICA, S.A. PHARMACHEMIE B.V
NL/H/0890/001
RVG 33553
ACTAVIS GROUP PTC EHF.
NL
NL/H/0890/001
RVG 33553
ACTAVIS GROUP PTC EHF.
NL
NL/H/0890/002
RVG 33554
ACTAVIS GROUP PTC EHF.
NL
NL/H/0890/002
RVG 33554
ACTAVIS GROUP PTC EHF.
NL
NL/H/0890/003
RVG 33555
ACTAVIS GROUP PTC EHF.
NL
NL/H/0890/003
RVG 33555
ACTAVIS GROUP PTC EHF.
NL
not available
RVG 21626
APOTEX EUROPE B.V.
NL
NL/H/2480/001
RVG 110742
AUROBINDO PHARMA B.V.
NL
not available
RVG 25343
PHARMACHEMIE B.V
NL
List of nationally authorised medicinal products EMA/140794/2018
PT PT PT NL
Page 129/220
Product Name (in authorisation country) Tramadol HCl capsule CF 50 mg, capsules Tramadol HCl druppels CF 100 mg/ml, druppels voor orale toediening. Tramadol HCl Duiven retard 100 mg, tabletten met gereguleerde afgifte Tramadol HCl Duiven retard 100 mg, tabletten met gereguleerde afgifte Tramadol HCl Duiven retard 150 mg, tabletten met gereguleerde afgifte Tramadol HCl Duiven retard 150 mg, tabletten met gereguleerde afgifte Tramadol HCl Duiven retard 200 mg, tabletten met gereguleerde afgifte Tramadol HCl Duiven retard 200 mg, tabletten met gereguleerde afgifte Tramadol HCl Mylan 50 mg, capsules Tramadol HCl ratiopharm 50 mg, capsules. Tramadol HCl Retard 100 mg Teva, tabletten met gereguleerde afgifte Tramadol HCl Retard 100 mg, tabletten met gereguleerde afgifte Tramadol HCl retard 100 mg, tabletten met gereguleerde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0282/001
RVG 27163
CENTRAFARM B.V.
NL
DE/H/0282/002
RVG 27165
CENTRAFARM B.V.
NL
NL/H/0538/001
RVG 30562
ICC B.V.
NL
NL/H/0539/001
RVG 30577
ICC B.V.
NL
NL/H/0538/002
RVG 30563
ICC B.V.
NL
NL/H/0539/002
RVG 30578
ICC B.V.
NL
NL/H/0538/003
RVG 30564
ICC B.V.
NL
NL/H/0539/003
RVG 30579
ICC B.V.
NL
not available
RVG 26280
MYLAN B.V.
NL
not available
RVG 21682
NL
not available
RVG 33751
RATIOPHARM NEDERLAND B.V TEVA NEDERLAND B.V.
not available
RVG 35254
ICC B.V.
NL
NL/H/0888/001
RVG 32921
ICC B.V.
NL
List of nationally authorised medicinal products EMA/140794/2018
NL
Page 130/220
Product Name (in authorisation country) Tramadol HCl retard 100 mg, tabletten met gereguleerde afgifte Tramadol HCl retard 100 mg, tabletten met gereguleerde afgifte Tramadol HCl Retard 150 mg Teva, tabletten met gereguleerde afgifte Tramadol HCl Retard 150 mg, tabletten met gereguleerde afgifte Tramadol HCl retard 150 mg, tabletten met gereguleerde afgifte Tramadol HCl retard 150 mg, tabletten met gereguleerde afgifte Tramadol HCl retard 150 mg, tabletten met gereguleerde afgifte Tramadol HCl Retard 200 mg Teva, tabletten met gereguleerde afgifte Tramadol HCl Retard 200 mg, tabletten met gereguleerde afgifte Tramadol HCl retard 200 mg, tabletten met gereguleerde afgifte Tramadol HCl retard 200 mg, tabletten met gereguleerde afgifte Tramadol HCl retard 200 mg, tabletten met gereguleerde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0889/001
RVG 32924
ICC B.V.
NL
NL/H/0892/001
RVG 33754
ICC B.V.
NL
not available
RVG 33752
TEVA NEDERLAND B.V.
NL
not available
RVG 35255
ICC B.V.
NL
NL/H/0888/002
RVG 32922
ICC B.V.
NL
NL/H/0889/002
RVG 32925
ICC B.V.
NL
NL/H/0892/002
RVG 33755
ICC B.V.
NL
not available
RVG 33753
TEVA NEDERLAND B.V.
NL
not available
RVG 35256
ICC B.V.
NL
NL/H/0888/003
RVG 32923
ICC B.V.
NL
NL/H/0889/003
RVG 32926
ICC B.V.
NL
NL/H/0892/003
RVG 33756
ICC B.V.
NL
List of nationally authorised medicinal products EMA/140794/2018
Page 131/220
Product Name (in authorisation country) Tramadol HCl retard CF 100 mg, tabletten met gereguleerde afgifte Tramadol HCl retard CF 100 mg, tabletten met gereguleerde afgifte Tramadol HCl retard CF 200 mg, tabletten met gereguleerde afgifte Tramadol HCl retard CF 200 mg, tabletten met gereguleerde afgifte Tramadol HCl Retard Mylan 100 mg, tabletten met gereguleerde afgifte Tramadol HCl Retard Mylan 100 mg, tabletten met gereguleerde afgifte Tramadol HCl Retard Mylan 100 mg, tabletten met verlengde afgifte Tramadol HCl Retard Mylan 150 mg, tabletten met gereguleerde afgifte Tramadol HCl Retard Mylan 150 mg, tabletten met gereguleerde afgifte Tramadol HCl Retard Mylan 150 mg, tabletten met verlengde afgifte Tramadol HCl Retard Mylan 200 mg, tabletten met gereguleerde afgifte Tramadol HCl Retard Mylan 200 mg, tabletten met gereguleerde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
RVG 34128
CENTRAFARM B.V.
NL
not available
RVG 34128
CENTRAFARM B.V.
NL
not available
RVG 34130
CENTRAFARM B.V.
NL
not available
RVG 34130
CENTRAFARM B.V.
NL
not available
RVG 25699
MYLAN B.V.
NL
not available
RVG 25699
MYLAN B.V.
NL
UK/H/4160/001
RVG 109064
MYLAN B.V.
NL
not available
RVG 25700
MYLAN B.V.
NL
not available
RVG 25700
MYLAN B.V.
NL
UK/H/4160/002
RVG 109065
MYLAN B.V.
NL
not available
RVG 25701
MYLAN B.V.
NL
not available
RVG 25701
MYLAN B.V.
NL
List of nationally authorised medicinal products EMA/140794/2018
Page 132/220
Product Name (in authorisation country) Tramadol HCl Retard Mylan 200 mg, tabletten met verlengde afgifte Tramadol HCl Sandoz bruis 50 mg, bruistabletten Tramadol HCl Sandoz capsule 50 mg, capsules Tramadol HCl Sandoz retard 100, tabletten met verlengde afgifte 100 mg Tramadol HCl Sandoz retard 150, tabletten met verlengde afgifte 150 mg Tramadol HCl Sandoz retard 200, tabletten met verlengde afgifte 200 mg Tramadol HCl Teva 50 mg, capsules Tramadol HCl zetpil CF 100 mg, zetpillen Tramadol Heumann Tropfen
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/4160/003
RVG 109066
MYLAN B.V.
NL
DE/H/0144/001
RVG 23527
SANDOZ B.V.
NL
not available
RVG 21690
SANDOZ B.V.
NL
NL/H/0483/001
RVG 25693
SANDOZ B.V.
NL
NL/H/0483/002
RVG 25694
SANDOZ B.V.
NL
NL/H/0483/003
RVG 25695
SANDOZ B.V.
NL
not available
RVG 22031
TEVA NEDERLAND B.V.
NL
DE/H/0282/003
RVG 27166
CENTRAFARM B.V.
NL
-
25530.00.00
DE
Tramadol Hexal 100 mg kapslar, hårda Tramadol HEXAL 100 mg, kapseli, kova Tramadol HEXAL 50 mg kapsel, hard Tramadol Hexal 50 mg kapslar, hårda Tramadol HEXAL 50 mg, kapseli, kova Tramadol Hikma 100 mg Injektionslösung Tramadol Hikma 100 mg Injektionslösung
not available
13466
HEUMANN PHARMA GMBH & CO. GENERICA KG HEXAL A/S
not available
12731
HEXAL A/S
FI
not available
99-7755
HEXAL A/S
NO
not available
13465
HEXAL A/S
SE
not available
12729
HEXAL A/S
FI
not available
30181.00.00
DE
not available
30181.00.00
HIKMA FARMACÊUTICA (PORTUGAL), S.A. HIKMA FARMACÊUTICA (PORTUGAL), S.A.
List of nationally authorised medicinal products EMA/140794/2018
SE
DE
Page 133/220
Product Name (in authorisation country) Tramadol Hydrochloride 50 mg Capsules Tramadol hydrochloride 50 mg capsules Tramadol hydrochloride 50 mg capsules Tramadol hydrochloride 50 mg/ml solution for injection or infusion Tramadol hydrochloride 50 mg/ml solution for injection or infusion Tramadol Hydrochloride 50mg Capsules Tramadol Hydrochloride 50mg Capsules Tramadol Hydrochloride 50mg Capsules Tramadol Hydrochloride 50mg Capsules TRAMADOL HYDROCHLORIDE 50mg CAPSULES Tramadol hydrochloride 50mg Capsules Tramadol Hydrochloride 50mg Effervescent Tablets Tramadol Hydrochloride 50mg Effervescent Tablets Tramadol Hydrochloride 50mg Effervescent Tablets TRAMADOL HYDROCHLORIDE 50MG HARD CAPSULES Tramadol Hydrochloride 50mg Hard Capsules
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
PL 44041/0037
NOUMED LIFE SCIENCES
UK
not available
PL 17780/0139
UK
not available
PL 17780/0139
PT/H/1548/001
PL 16363/0467
WINTHROP PHARMACEUTICALS UK LTD WINTHROP PHARMACEUTICALS UK LTD MILPHARM LIMITED
UK/H/5235/001
PL 01502/0085
HAMELN PHARMACEUTICALS LTD
UK
not available
PL 20117/0086
UK
not available
PL 20117/0086
not available
PL 30464/0037
not available
PL 11311/0084
UK/H/0380/001
PL 0142/0484
MORNINGSIDE HEALTHCARE LTD MORNINGSIDE HEALTHCARE LTD ATHLONE PHARMACEUTICALS LIMITED TILLOMED LABORATORIES LTD ACTAVIS UK LTD.
not available
PL 10622/0050
PLIVA PHARMA LIMITED
UK
not available
PL 28444/0217
UK
not available
PL 36722/0119
not available
PL 36722/0119
FR/H/0403/001
PA 1380/96/1
ACTIVASE PHARMACEUTICALS LIMITED SPECIAL CONCEPT DEVELOPMENT (UK) LTD SPECIAL CONCEPT DEVELOPMENT (UK) LTD ACTAVIS GROUP PTC EHF.
FR/H/0403/001/DC
PA 1380/96/1
ACTAVIS GROUP PTC EHF.
IE
List of nationally authorised medicinal products EMA/140794/2018
UK UK
UK UK UK UK
UK UK IE
Page 134/220
Product Name (in authorisation country) Tramadol Hydrochloride Capsules 50mg Tramadol Hydrochloride Capsules 50mg Tramadol Kalceks 100 mg/2 ml šķīdums injekcijām TRAMADOL KERN PHARMA 50 mg cápsulas EFG Tramadol Krka 100 mg čepići Tramadol Krka 100 mg ilgstošās darbības tabletes Tramadol Krka 100 mg pailginto atpalaidavimo tabletės Tramadol Krka 100 mg žvakutės Tramadol Krka 100 mg/ 2 ml šķīdums injekcijām Tramadol Krka 100 mg/2 ml injekcinis tirpalas Tramadol Krka 100 mg/2 ml otopina za injekcije Tramadol Krka 100 mg/ml geriamieji lašai (tirpalas) Tramadol Krka 100 mg/ml geriamieji lašai (tirpalas) Tramadol Krka 100 mg/ml oralne kapi Tramadol Krka 150 mg ilgstošās darbības tabletes Tramadol Krka 150 mg pailginto atpalaidavimo tabletės Tramadol Krka 200 mg ilgstošās darbības tabletes
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
AA054/06901
MT
not available
PL 20075/0290
not available
16-0115
ACCORD HEALTHCARE LIMITED ACCORD HEALTHCARE LIMITED KALCEKS
not available
63.920
KERN PHARMA, S.L.
ES
not available
HR-H-767374749
KRKA-FARMA D.O.O.
HR
not available
00-0666
KRKA, D.D., NOVO MESTO
LV
not available
LT/1/94/1055/007
KRKA, D.D., NOVO MESTO
LT
not available
LT/1/94/1055/002
KRKA, D.D., NOVO MESTO
LT
not available
01-0148
KRKA, D.D., NOVO MESTO
LV
not available
LT/1/94/1055/006
KRKA, D.D., NOVO MESTO
LT
not available
UP/I-530-09/11-02/292
KRKA-FARMA D.O.O.
HR
not available
LT/1/94/1055/003
KRKA, D.D., NOVO MESTO
LT
not available
LT/1/94/1055/004
KRKA, D.D., NOVO MESTO
LT
not available
UP/I-530-09/11-02/290
KRKA-FARMA D.O.O.
HR
not available
03-0206
KRKA, D.D., NOVO MESTO
LV
not available
LT/1/94/1055/008
KRKA, D.D., NOVO MESTO
LT
not available
03-0207
KRKA, D.D., NOVO MESTO
LV
List of nationally authorised medicinal products EMA/140794/2018
UK LV
Page 135/220
Product Name (in authorisation country) Tramadol Krka 200mg pailginto atpalaidavimo tabletės Tramadol Krka 50 mg cietās kapsulas Tramadol Krka 50 mg kapsule Tramadol Krka 50 mg kietosios kapsulės Tramadol Krka 50 mg/ ml injekcinis tirpalas Tramadol Krka 50 mg/ml otopina za injekcije Tramadol Krka 50 mg/ml šķīdums injekcijām Tramadol Krka 50 mg/ml süstelahus Tramadol Krka, 100 mg rektaalsuposiidid Tramadol Krka, 100 mg toimeainet prolongeeritult vabastavad tabletid Tramadol Krka, 100 mg/ml suukaudsed tilgad, lahus Tramadol Krka, 50 mg kõvakapslid Tramadol Labesfal, 100 mg, comprimidos de libertação prolongada Tramadol Labesfal, 100 mg/2 ml, solução injectável Tramadol Labesfal, 100 mg/2 ml, solução injectável Tramadol Labesfal, 50 mg cápsulas
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
LT/1/94/1055/009
KRKA, D.D., NOVO MESTO
LT
not available
96-0110
KRKA, D.D., NOVO MESTO
LV
not available
UP/I-530-09/11-02/289
KRKA-FARMA D.O.O.
HR
not available
LT/1/94/1055/001
KRKA, D.D., NOVO MESTO
LT
not available
LT/1/94/1055/005
KRKA, D.D., NOVO MESTO
LT
not available
UP/I-530-09/11-02/291
KRKA-FARMA D.O.O.
HR
not available
96-0107
KRKA, D.D., NOVO MESTO
LV
not available
135196
KRKA, D.D., NOVO MESTO
EE
not available
139696
KRKA, D.D., NOVO MESTO
EE
not available
331200
KRKA, D.D., NOVO MESTO
EE
not available
148696
KRKA, D.D., NOVO MESTO
EE
not available
139596
KRKA, D.D., NOVO MESTO
EE
not available
4348587
GENERIS FARMACÊUTICA, S.A.
PT
not available
3210994
PT
not available
4842399
not available
3827599
LABESFAL LABORATORIOS ALMIRO, S.A. LABESFAL LABORATORIOS ALMIRO, S.A. GENERIS FARMACÊUTICA, S.A.
List of nationally authorised medicinal products EMA/140794/2018
PT PT
Page 136/220
Product Name (in authorisation country) Tramadol Labesfal, 50 mg cápsulas Tramadol Labesfal, 50 mg/1 ml, solução injectável Tramadol Labesfal, 50 mg/1 ml, solução injectável Tramadol Lannacher 100 mg ilgstosas darbibas tabletes Tramadol Lannacher 100 mg pailginto atpalaidavimo tabletes Tramadol Lannacher 100 mg pailginto atpalaidavimo tabletės Tramadol Lannacher 100 mg suposiidid Tramadol Lannacher 100 mg supozitoriji Tramadol Lannacher 100 mg žvakutes Tramadol Lannacher 100 mg, toimeainet prolongeeritult vabastavad tabletid Tramadol Lannacher 100 mg/2 ml injekcinis tirpalas Tramadol Lannacher 100 mg/2 ml injekcinis tirpalas Tramadol Lannacher 100 mg/2 ml šķīdums injekcijām Tramadol Lannacher 100 mg/2 ml süstelahus Tramadol Lannacher 100 mg/ml geriamieji lašai, tirpalas
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
3827698
PT
not available
3210796
not available
4842290
not available
00-1168
GENERIS FARMACÊUTICA, S.A. LABESFAL LABORATORIOS ALMIRO, S.A. LABESFAL LABORATORIOS ALMIRO, S.A. G.L. PHARMA GMBH
not available
LT/1/97/1431/002
G.L. PHARMA GMBH
LT
not available
LT/1/97/1431/001
G.L. PHARMA GMBH
LT
not available
321800
G.L. PHARMA GMBH
EE
not available
99-0232
G.L. PHARMA GMBH
LV
not available
LT/1/97/1431/009
G.L. PHARMA GMBH
LT
not available
345101
G.L. PHARMA GMBH
EE
not available
LT/1/97/1431/010
G.L. PHARMA GMBH
LT
not available
LT/1/97/1431/011
G.L. PHARMA GMBH
LT
not available
99-0235
G.L. PHARMA GMBH
LV
not available
321600
G.L. PHARMA GMBH
EE
not available
LT/1/97/1431/012
G.L. PHARMA GMBH
LT
List of nationally authorised medicinal products EMA/140794/2018
PT PT LV
Page 137/220
Product Name (in authorisation country) Tramadol Lannacher 100 mg/ml pilieni iekšķīgai lietošanai, šķīdums Tramadol Lannacher 150 mg ilgstosas darbibas tabletes Tramadol Lannacher 150 mg pailginto atpalaidavimo tabletes Tramadol Lannacher 150 mg pailginto atpalaidavimo tabletes Tramadol Lannacher 150 mg, toimeainet prolongeeritult vabastavad tabletid Tramadol Lannacher 200 mg ilgstosas darbibas tabletes Tramadol Lannacher 200 mg pailginto atpalaidavimo tabletes Tramadol Lannacher 200 mg pailginto atpalaidavimo tabletes Tramadol Lannacher 200 mg, toimeainet prolongeeritult vabastavad tabletid Tramadol Lannacher 50 mg apvalkotās tabletes Tramadol Lannacher 50 mg plėvele dengtos tabletės Tramadol Lannacher 50 mg plėvele dengtos tabletės Tramadol Lannacher, 100 mg/ml suukaudsed tilgad
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
99-0514
G.L. PHARMA GMBH
LV
not available
03-0120
G.L. PHARMA GMBH
LV
not available
LT/1/97/1431/004
G.L. PHARMA GMBH
LT
not available
LT/1/97/1431/003
G.L. PHARMA GMBH
LT
not available
392202
G.L. PHARMA GMBH
EE
not available
03-0121
G.L. PHARMA GMBH
LV
not available
LT/1/97/1431/006
G.L. PHARMA GMBH
LT
not available
LT/1/97/1431/005
G.L. PHARMA GMBH
LT
not available
392302
G.L. PHARMA GMBH
EE
not available
99-0233
G.L. PHARMA GMBH
LV
not available
LT/1/97/1431/007
G.L. PHARMA GMBH
LT
not available
LT/1/97/1431/008
G.L. PHARMA GMBH
LT
not available
321700
G.L. PHARMA GMBH
EE
List of nationally authorised medicinal products EMA/140794/2018
Page 138/220
Product Name (in authorisation country) Tramadol Lannacher, 50 mg õhukese polümeerikilega kaetud tabletid TRAMADOL LAVOISIER® 50 mg/ ml, solution injectable TRAMADOL LAVOISIER® 50 mg/ ml, solution injectable Tramadol LIBRAPHARM 100 mg, Injektionslösung Tramadol LIBRAPHARM 100 mg/ml Lösung zum Einnehmen Tramadol LIBRAPHARM 50 mg, Injektionslösung Tramadol LIBRAPHARM Kapseln, 50 mg, Hartkapseln Tramadol LIBRAPHARM retard 100 mg Retardtabletten Tramadol LIBRAPHARM retard 150 mg Retardtabletten Tramadol LIBRAPHARM retard 200 mg Retardtabletten Tramadol LIBRAPHARM retard 50 mg Retardtabletten Tramadol LIBRAPHARM Zäpfchen, 100 mg Tramadol Lösung - 1APharma TRAMADOL MABO 50 mg cápsulas E.F.G.
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
274199
G.L. PHARMA GMBH
EE
not available
VNL35853-3400957486020
FR
not available
VNL35853-3400957486020
not available
13144.01.03
LABORATOIRES CHAIX ET DU MARAIS LABORATOIRES CHAIX ET DU MARAIS LIBRA-PHARM GMBH
not available
13144.00.02
LIBRA-PHARM GMBH
DE
not available
13144.00.03
LIBRA-PHARM GMBH
DE
not available
13144.00.01
LIBRA-PHARM GMBH
DE
DE/H/1093/002
69192.00.00
LIBRA-PHARM GMBH
DE
DE/H/1093/003
69193.00.00
LIBRA-PHARM GMBH
DE
DE/H/1093/004
69194.00.00
LIBRA-PHARM GMBH
DE
DE/H/1093/001
69191.00.00
LIBRA-PHARM GMBH
DE
not available
13144.00.00
LIBRA-PHARM GMBH
DE
not available
32751.00.01
1 A PHARMA GMBH
DE
not available
63.758
MABO-FARMA, S.A.
ES
List of nationally authorised medicinal products EMA/140794/2018
FR DE
Page 139/220
Product Name (in authorisation country) TRAMADOL MEDA 100mg/2ml SOLUÇÃO INJECTÁVEL TRAMADOL MEDA 100mg/ml GOTAS ORAIS SOLUÇÃO TRAMADOL MEDA 100mg/ml GOTAS ORAIS SOLUÇÃO Tramadol Mylan 100 mg comprimidos de libertação prolongada Tramadol Mylan 100 mg comprimidos de libertação prolongada Tramadol Mylan 100 mg comprimidos de libertação prolongada Tramadol Mylan 100 mg comprimidos de libertação prolongada Tramadol Mylan 100 mg comprimidos de libertação prolongada Tramadol Mylan 100 mg comprimidos de libertação prolongada Tramadol Mylan 100 mg Retardtabletten Tramadol Mylan 100 mg Retardtabletten Tramadol Mylan 100 mg Tablety s predĺženým uvoľňovaním Tramadol Mylan 100 mg, tablety s prodlouženým uvolňováním
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
2831188
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
not available
3081080
PT
not available
2831089
UK/H/4160/001
5463179
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A. MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A. MYLAN, LDA
UK/H/4160/001
5463211
MYLAN, LDA
PT
UK/H/4160/001
5463328
MYLAN, LDA
PT
UK/H/4160/001
5463302
MYLAN, LDA
PT
UK/H/4160/001
5463203
MYLAN, LDA
PT
UK/H/4160/001
5463310
MYLAN, LDA
PT
not available
39923.00.00
MYLAN DURA GMBH
DE
not available
39923.00.00
MYLAN DURA GMBH
DE
UK/H/4160/001
65/0556/12-S
GENERICS [UK] LIMITED
SK
UK/H/4160/001
65/120/13-C
GENERICS [UK] LIMITED
CZ
List of nationally authorised medicinal products EMA/140794/2018
PT PT
Page 140/220
Product Name (in authorisation country) Tramadol Mylan 100 mg/ml Lösung zum Einnehmen Tramadol Mylan 100 mg/ml Lösung zum Einnehmen Tramadol Mylan 150 mg comprimidos de libertação prolongada Tramadol Mylan 150 mg comprimidos de libertação prolongada Tramadol Mylan 150 mg comprimidos de libertação prolongada Tramadol Mylan 150 mg comprimidos de libertação prolongada Tramadol Mylan 150 mg comprimidos de libertação prolongada Tramadol Mylan 150 mg comprimidos de libertação prolongada Tramadol Mylan 150 mg Tablety s predĺženým uvoľňovaním Tramadol Mylan 150 mg tablety s prodlouženým uvolňováním Tramadol Mylan 200 mg comprimidos de libertação prolongada Tramadol Mylan 200 mg comprimidos de libertação prolongada Tramadol Mylan 200 mg comprimidos de libertação prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
6006921.00.00
DE
not available
6006921.00.00
UK/H/4160/002
5463245
KREWEL MEUSELBACH GMBH KREWEL MEUSELBACH GMBH MYLAN, LDA
UK/H/4160/002
5463229
MYLAN, LDA
PT
UK/H/4160/002
5463336
MYLAN, LDA
PT
UK/H/4160/002
5463237
MYLAN, LDA
PT
UK/H/4160/002
5463344
MYLAN, LDA
PT
UK/H/4160/002
5463351
MYLAN, LDA
PT
UK/H/4160/002
65/0557/12-S
GENERICS [UK] LIMITED
SK
UK/H/4160/002
65/121/13-C
GENERICS [UK] LIMITED
CZ
UK/H/4160/003
5463260
MYLAN, LDA
PT
UK/H/4160/003
5463252
MYLAN, LDA
PT
UK/H/4160/003
5463369
MYLAN, LDA
PT
List of nationally authorised medicinal products EMA/140794/2018
DE PT
Page 141/220
Product Name (in authorisation country) Tramadol Mylan 200 mg comprimidos de libertação prolongada Tramadol Mylan 200 mg comprimidos de libertação prolongada Tramadol Mylan 200 mg comprimidos de libertação prolongada Tramadol Mylan 200 mg Tablety s predĺženým uvoľňovaním Tramadol Mylan 200 mg tablety s prodlouženým uvolňováním TRAMADOL MYLAN PHARMA LP 100 mg, comprimé pelliculé à libération prolongée TRAMADOL MYLAN PHARMA LP 100 mg, comprimé pelliculé à libération prolongée TRAMADOL MYLAN PHARMA LP 150 mg, comprimé pelliculé à libération prolongée TRAMADOL MYLAN PHARMA LP 150 mg, comprimé pelliculé à libération prolongée TRAMADOL MYLAN PHARMA LP 200 mg, comprimé pelliculé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/4160/003
5463377
MYLAN, LDA
PT
UK/H/4160/003
5463401
MYLAN, LDA
PT
UK/H/4160/003
5463278
MYLAN, LDA
PT
UK/H/4160/003
65/0558/12-S
GENERICS [UK] LIMITED
SK
UK/H/4160/003
65/122/13-C
GENERICS [UK] LIMITED
CZ
not available
NL 39453
MYLAN S.A.S
FR
not available
NL 39453
MYLAN S.A.S
FR
not available
NL 39454
MYLAN S.A.S
FR
not available
NL 39454
MYLAN S.A.S
FR
not available
NL 39455
MYLAN S.A.S
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 142/220
Product Name (in authorisation country) TRAMADOL MYLAN PHARMA LP 200 mg, comprimé pelliculé à libération prolongée TRAMADOL NORMON 100 mg/2 ml Solución inyectable EFG TRAMADOL NORMON 50 mg Cápsulas EFG TRAMADOL RANBAXY 50 MG CAPSULAS EFG TRAMADOL RANBAXY L.P. 100 mg, comprimé à libération prolongée TRAMADOL RANBAXY L.P. 150 mg, comprimé à libération prolongée TRAMADOL RANBAXY L.P. 200 mg, comprimé à libération prolongée Tramadol ratiopharm 50 mg cápsulas duras EFG Tramadol Retard "Hexal" Tramadol Retard "Hexal" Tramadol Retard "Hexal" Tramadol Retard ”Actavis”, depottabletter Tramadol Retard ”Actavis”, depottabletter Tramadol Retard ”Actavis”, depottabletter Tramadol Retard 100 mg, capsules met verlengde afgifte, hard
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
NL 39455
MYLAN S.A.S
FR
not available
63.734
LABORATORIOS NORMON, S.A.
ES
not available
63910
ES
not available
64.305
not available
NL 34291
LABORATORIOS NORMON, S.A. LABORATORIOS RANBAXY S.L. RANBAXY PHARMACIE GENERIQUES
not available
NL 34292
RANBAXY PHARMACIE GENERIQUES
FR
not available
NL 34 293
RANBAXY PHARMACIE GENERIQUES
FR
not available
63.472
RATIOPHARM ESPANA SA
ES
DE/H/0448/003 DE/H/0448/002 DE/H/0448/001 NL/H/0890/001
36839 36838 36837 40152
HEXAL A/S HEXAL A/S HEXAL A/S ACTAVIS GROUP HF.
DK DK DK DK
NL/H/0890/002
40153
ACTAVIS GROUP HF.
DK
NL/H/0890/003
40154
ACTAVIS GROUP HF.
DK
UK/H/0225/002
RVG 22326
MEDA PHARMA B.V.
NL
List of nationally authorised medicinal products EMA/140794/2018
ES FR
Page 143/220
Product Name (in authorisation country) Tramadol Retard 100 mg, capsules met verlengde afgifte, hard* Tramadol Retard 150 mg comprimate cu eliberare prelungită Tramadol Retard 150 mg, capsules met verlengde afgifte, hard Tramadol Retard 150 mg, capsules met verlengde afgifte, hard* Tramadol Retard 200 mg comprimate cu eliberare prelungita Tramadol Retard 200 mg, capsules met verlengde afgifte, hard Tramadol Retard 200 mg, capsules met verlengde afgifte, hard* Tramadol Retard 50 mg, capsules met verlengde afgifte, hard Tramadol Retard 50 mg, capsules met verlengde afgifte, hard* Tramadol Retard Actavis 100 mg Tramadol Retard Actavis 100 mg depottabletter Tramadol Retard Actavis 100 mg tablety s predlženým uvolnovaním Tramadol Retard Actavis 150 mg depottabletter
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
RVG 23007 = RVG 22326
MEDA PHARMA B.V.
NL
not available
6137/2014/01
KRKA, D.D., NOVO MESTO
RO
UK/H/0225/003
RVG 22327
MEDA PHARMA B.V.
NL
not available
RVG 23008=22327
MEDA PHARMA B.V.
NL
not available
6138/2014/01
KRKA, D.D., NOVO MESTO
RO
UK/H/0225/004
RVG 22328
MEDA PHARMA B.V.
NL
not available
RVG 23009=22328
MEDA PHARMA B.V.
NL
UK/H/0225/001
RVG 22325
MEDA PHARMA B.V.
NL
not available
RVG 23006=22325
MEDA PHARMA B.V.
NL
NL/H/0890/001
65/199/07-C
ACTAVIS GROUP HF.
CZ
NL/H/0890/001
24560
ACTAVIS GROUP PTC EHF.
SE
NL/H/0890/001
65/0216/07-S
ACTAVIS GROUP HF.
SK
NL/H/0890/002
24561
ACTAVIS GROUP PTC EHF.
SE
List of nationally authorised medicinal products EMA/140794/2018
Page 144/220
Product Name (in authorisation country) Tramadol Retard Actavis 150 mg tablety s predĺženým uvoľňovaním Tramadol Retard Actavis 200 mg depottabletter Tramadol Retard Actavis 200 mg tablety s predĺženým uvoľňovaním Tramadol Retard Apotex 100 mg comprimidos de liberación prolongada EFG Tramadol Retard Apotex 150 mg comprimidos de liberación prolongada EFG Tramadol Retard Apotex 200 mg comprimidos de liberación prolongada EFG. Tramadol retard Combix 100 mg comprimidos de liberación prolongada EFG Tramadol retard Combix 150 mg comprimidos de liberación prolongada EFG Tramadol retard Combix 200 mg comprimidos de liberación prolongada EFG Tramadol Retard EG 100 mg comprimés à libération prolongée Tramadol Retard EG 100 mg comprimés à libération prolongée Tramadol Retard EG 100 mg comprimés à libération prolongée Tramadol Retard EG 100 mg Retardtabletten
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0890/002
65/0217/07-S
ACTAVIS GROUP HF.
SK
NL/H/0890/003
24562
ACTAVIS GROUP PTC EHF.
SE
NL/H/0890/003
65/0218/07-S
ACTAVIS GROUP HF.
SK
NL/H/0539/001
72427
APOTEX EUROPE B.V.
ES
NL/H/0539/002
71710
APOTEX EUROPE B.V.
ES
NL/H/0539/003
72.430.
APOTEX EUROPE B.V.
ES
not available
74.252
LABORATORIOS COMBIX, S.L.U.
ES
not available
74.253
LABORATORIOS COMBIX, S.L.U.
ES
not available
74.254
LABORATORIOS COMBIX, S.L.U.
ES
NL/H/0888/001
BE300203
EUROGENERICS N.V./S.A.
BE
NL/H/0888/001
BE300212
EUROGENERICS N.V./S.A.
BE
NL/H/0888/001
BE300221
EUROGENERICS N.V./S.A.
BE
NL/H/0888/001
BE300212
EUROGENERICS N.V./S.A.
BE
List of nationally authorised medicinal products EMA/140794/2018
Page 145/220
Product Name (in authorisation country) Tramadol Retard EG 100 Retardtabletten Tramadol Retard EG 100 Retardtabletten Tramadol Retard EG 100 tabletten met verlengde afgifte Tramadol Retard EG 100 tabletten met verlengde afgifte Tramadol Retard EG 100 tabletten met verlengde afgifte Tramadol Retard EG 150 comprimés à libération prolongée Tramadol Retard EG 150 comprimés à libération prolongée Tramadol Retard EG 150 comprimés à libération prolongée Tramadol Retard EG 150 tabletten met verlengde afgifte Tramadol Retard EG 150 tabletten met verlengde afgifte Tramadol Retard EG 150 tabletten met verlengde afgifte Tramadol Retard EG 150 Retardtabletten Tramadol Retard EG 150 Retardtabletten
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
mg
NL/H/0888/001
BE300221
EUROGENERICS N.V./S.A.
BE
mg
NL/H/0888/001
BE300203
EUROGENERICS N.V./S.A.
BE
mg
NL/H/0888/001
BE300203
EUROGENERICS N.V./S.A.
BE
mg
NL/H/0888/001
BE300212
EUROGENERICS N.V./S.A.
BE
mg
NL/H/0888/001
BE300221
EUROGENERICS N.V./S.A.
BE
mg
NL/H/0888/002
BE300237
EUROGENERICS N.V./S.A.
BE
mg
NL/H/0888/002
BE300246
EUROGENERICS N.V./S.A.
BE
mg
NL/H/0888/002
BE300255
EUROGENERICS N.V./S.A.
BE
mg
NL/H/0888/002
BE300237
EUROGENERICS N.V./S.A.
BE
mg
NL/H/0888/002
BE300246
EUROGENERICS N.V./S.A.
BE
mg
NL/H/0888/002
BE300255
EUROGENERICS N.V./S.A.
BE
mg
NL/H/0888/002
BE300246
EUROGENERICS N.V./S.A.
BE
mg
NL/H/0888/002
BE300237
EUROGENERICS N.V./S.A.
BE
List of nationally authorised medicinal products EMA/140794/2018
Page 146/220
Product Name (in authorisation country) Tramadol Retard EG 150 mg Retardtabletten Tramadol Retard EG 200 mg comprimés à libération prolongée Tramadol Retard EG 200 mg comprimés à libération prolongée Tramadol Retard EG 200 mg comprimés à libération prolongée Tramadol Retard EG 200 mg Retardtabletten Tramadol Retard EG 200 mg Retardtabletten Tramadol Retard EG 200 mg Retardtabletten Tramadol Retard EG 200 mg tabletten met verlengde afgifte Tramadol Retard EG 200 mg tabletten met verlengde afgifte Tramadol Retard EG 200 mg tabletten met verlengde afgifte Tramadol Retard Hexal 100 mg depottablett Tramadol Retard HEXAL 100 mg depottabletti Tramadol Retard Hexal 150 mg depottablett Tramadol Retard Hexal 200 mg depottablett Tramadol Retard HEXAL 200 mg depottabletti
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0888/002
BE300255
EUROGENERICS N.V./S.A.
BE
NL/H/0888/003
BE300264
EUROGENERICS N.V./S.A.
BE
NL/H/0888/003
BE300273
EUROGENERICS N.V./S.A.
BE
NL/H/0888/003
BE300282
EUROGENERICS N.V./S.A.
BE
NL/H/0888/003
BE300273
EUROGENERICS N.V./S.A.
BE
NL/H/0888/003
BE300264
EUROGENERICS N.V./S.A.
BE
NL/H/0888/003
BE300282
EUROGENERICS N.V./S.A.
BE
NL/H/0888/003
BE300282
EUROGENERICS N.V./S.A.
BE
NL/H/0888/003
BE300273
EUROGENERICS N.V./S.A.
BE
NL/H/0888/003
BE300264
EUROGENERICS N.V./S.A.
BE
DE/H/0448/001
21235
HEXAL A/S
SE
DE/H/0448/001
19650
HEXAL A/S
FI
DE/H/0448/002
21236
HEXAL A/S
SE
DE/H/0448/003
21237
HEXAL A/S
SE
DE/H/0448/003
19651
HEXAL A/S
FI
List of nationally authorised medicinal products EMA/140794/2018
Page 147/220
Product Name (in authorisation country) Tramadol Retard Medartuum 100 mg depottabletter Tramadol Retard Medartuum 150 mg depottabletter Tramadol Retard Medartuum 200 mg depottabletter Tramadol Retard MYLAN 100 mg comprimidos de liberación prolongada EFG Tramadol Retard MYLAN 150 mg comprimidos de liberación prolongada EFG Tramadol Retard MYLAN 200 mg comprimidos de liberación prolongada EFG Tramadol retard NORMON 100 mg comprimidos de liberación prolongada EFG Tramadol retard NORMON 150 mg comprimidos de liberación prolongada EFG Tramadol retard NORMON 200 mg comprimidos de liberación prolongada EFG Tramadol retard ratiopharm 100 mg comprimidos de liberación prolongada EFG Tramadol retard ratiopharm 150 mg comprimidos de liberación prolongada EFG Tramadol retard ratiopharm 200 mg comprimidos de liberación prolongada EFG Tramadol Retard Sandoz 150 mg depottabletti
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0889/001
24429
MEDARTUUM MEDICAL AB
SE
NL/H/0889/002
24430
MEDARTUUM MEDICAL AB
SE
NL/H/0889/003
24431
MEDARTUUM MEDICAL AB
SE
UK/H/4160/001
76572
MYLAN PHARMACEUTICALS S.L.
ES
UK/H/4160/002
76573
MYLAN PHARMACEUTICALS S.L.
ES
UK/H/4160/003
76574
MYLAN PHARMACEUTICALS S.L.
ES
not available
76122
LABORATORIOS NORMON, S.A.
ES
not available
76124
LABORATORIOS NORMON, S.A.
ES
not available
76125
LABORATORIOS NORMON, S.A.
ES
not available
77217
RATIOPHARM ESPANA SA
ES
not available
77218
RATIOPHARM ESPANA SA
ES
not available
77219
RATIOPHARM ESPANA SA
ES
NL/H/0483/002
19304
SANDOZ A/S
FI
List of nationally authorised medicinal products EMA/140794/2018
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Product Name (in authorisation country) Tramadol retard STADA Genéricos 100 mg comprimidos de liberación prolongada EFG Tramadol retard STADA Genéricos 100 mg comprimidos de liberación prolongada EFG Tramadol retard STADA Genéricos 150 mg comprimidos de liberación prolongada EFG Tramadol retard STADA Genéricos 150 mg comprimidos de liberación prolongada EFG Tramadol retard STADA Genéricos 200 mg comprimidos de liberación prolongada EFG Tramadol retard STADA Genéricos 200 mg comprimidos de liberación prolongada EFG Tramadol retard Teva 100 mg comprimidos de liberación prolongada EFG Tramadol retard Teva 150 mg comprimidos de liberación prolongada EFG Tramadol retard Teva 200 mg comprimidos de liberación prolongada EFG Tramadol Ritisca 50 mg cápsulas Tramadol Sandoz 100 mg Brausetabletten
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
77.200
STADA GENÉRICOS, S.L.
ES
not available
77.200
STADA GENÉRICOS, S.L.
ES
not available
77.198
STADA GENÉRICOS, S.L.
ES
not available
77.198
STADA GENÉRICOS, S.L.
ES
not available
77.202
STADA GENÉRICOS, S.L.
ES
not available
77.202
STADA GENÉRICOS, S.L.
ES
not available
77206
TEVA PHARMA S.L.U
ES
not available
77232
TEVA PHARMA S.L.U
ES
not available
77231
TEVA PHARMA S.L.U
ES
PT/H/1576/001
5700257
PT
not available
39935.00.00
AUROVITAS UNIPESSOAL, LDA. HEXAL AG
List of nationally authorised medicinal products EMA/140794/2018
DE
Page 149/220
Product Name (in authorisation country) Tramadol Sandoz 100 mg, tabletten met verlengde afgifte Tramadol Sandoz 100 mg/ml druppels voor oraal gebruik, oplossing Tramadol Sandoz 100 mg/ml druppels voor oraal gebruik, oplossing Tramadol Sandoz 150 mg, tabletten met verlengde afgifte Tramadol Sandoz 200 mg, tabletten met verlengde afgifte TRAMADOL SANDOZ 50 mg cápsulas duras EFG TRAMADOL SANDOZ 50 mg cápsulas duras EFG Tramadol Sandoz 50 mg capsules, hard TRAMADOL SANDOZ 50 mg, comprimé TRAMADOL SANDOZ 50 mg, comprimé TRAMADOL SANDOZ 50 mg, comprimé TRAMADOL SANDOZ 50 mg, comprimé TRAMADOL SANDOZ L.P. 100 mg, comprimé pelliculé à libération prolongée TRAMADOL SANDOZ L.P. 100 mg, comprimé pelliculé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0288/001
BE235557
SANDOZ N.V.
BE
not available
BE 279325
SANDOZ N.V.
BE
not available
BE 279343
SANDOZ N.V.
BE
DE/H/0288/002
BE235566
SANDOZ N.V.
BE
DE/H/0288/003
BE235575
SANDOZ N.V.
BE
NL/H/0113/002
61.948
ES
NL/H/0113/002
61.948
not available
BE254344
SANDOZ FARMACÉUTICA, S.A. SANDOZ FARMACÉUTICA, S.A. SANDOZ N.V.
not available
351 065-8
SANDOZ
FR
not available
368 193-4
SANDOZ
FR
not available
351 066-4
SANDOZ
FR
not available
351 068-7
SANDOZ
FR
not available
383 988-4
SANDOZ
FR
not available
383 989-0
SANDOZ
FR
List of nationally authorised medicinal products EMA/140794/2018
ES BE
Page 150/220
Product Name (in authorisation country) TRAMADOL SANDOZ L.P. 100 mg, comprimé pelliculé à libération prolongée TRAMADOL SANDOZ L.P. 100 mg, comprimé pelliculé à libération prolongée TRAMADOL SANDOZ L.P. 150 mg, comprimé pelliculé à libération prolongée TRAMADOL SANDOZ L.P. 150 mg, comprimé pelliculé à libération prolongée TRAMADOL SANDOZ L.P. 150 mg, comprimé pelliculé à libération prolongée TRAMADOL SANDOZ L.P. 150 mg, comprimé pelliculé à libération prolongée TRAMADOL SANDOZ L.P. 200 mg, comprimé pelliculé à libération prolongée TRAMADOL SANDOZ L.P. 200 mg, comprimé pelliculé à libération prolongée TRAMADOL SANDOZ L.P. 200 mg, comprimé pelliculé à libération prolongée TRAMADOL SANDOZ L.P. 200 mg, comprimé pelliculé à libération prolongée Tramadol Sandoz Retard 200 mg tablety s prodlouženým uvolňováním Tramadol Sandoz UNO 150 mg Retardtabletten Tramadol Sandoz UNO 200 mg Retardtabletten
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
383 986-1
SANDOZ
FR
not available
383 987-8
SANDOZ
FR
not available
385 524-5
SANDOZ
FR
not available
385 525-1
SANDOZ
FR
not available
572 785-3
SANDOZ
FR
not available
572 787-6
SANDOZ
FR
not available
383 991-5
SANDOZ
FR
not available
572 175-0
SANDOZ
FR
not available
572 176-7
SANDOZ
FR
not available
383 990-9
SANDOZ
FR
DE/H/0576/001
65/392/06-C
SANDOZ GMBH
CZ
not available
44610.01.00
HEXAL AG
DE
DE/H/0576/001
44610.02.00
HEXAL AG
DE
List of nationally authorised medicinal products EMA/140794/2018
Page 151/220
Product Name (in authorisation country) Tramadol soluţie injectabilă 100 mg/2 ml Tramadol soluţie injectabilă 50 mg/1 ml Tramadol SOPHARMA 50 mg/ml oldatos injekció TRAMADOL SR ZENTIVA 100 mg comprimate cu eliberare prelungită TRAMADOL SR ZENTIVA 100 mg comprimate cu eliberare prelungită TRAMADOL SR ZENTIVA 100 mg comprimate cu eliberare prelungită TRAMADOL SR ZENTIVA 100 mg comprimate cu eliberare prelungită TRAMADOL SR ZENTIVA 150 mg comprimate cu eliberare prelungită TRAMADOL SR ZENTIVA 150 mg comprimate cu eliberare prelungită TRAMADOL SR ZENTIVA 150 mg comprimate cu eliberare prelungită TRAMADOL SR ZENTIVA 150 mg comprimate cu eliberare prelungită TRAMADOL STADA 50 mg cápsulas duras EFG TRAMADOL STADA 50 mg cápsulas duras EFG Tramadol STADA 50 mg kapslar, hårda
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
2848/2002/01
KRKA, D.D., NOVO MESTO
RO
not available
2846/2002/01
KRKA, D.D., NOVO MESTO
RO
not available
OGYI-T-22657/01
SOPHARMA AD
HU
not available
8763/2016/03
ZENTIVA, A.S.
RO
not available
8763/2016/02
ZENTIVA, A.S.
RO
not available
8763/2016/04
ZENTIVA, A.S.
RO
not available
8763/2016/01
ZENTIVA, A.S.
RO
not available
8764/2016/03
ZENTIVA, A.S.
RO
not available
8764/2016/02
ZENTIVA, A.S.
RO
not available
8764/2016/04
ZENTIVA, A.S.
RO
not available
8764/2016/01
ZENTIVA, A.S.
RO
not available
64.215
LABORATORIO STADA, S.L.
ES
not available
64.215
LABORATORIO STADA, S.L.
ES
DE/H/0282/001
17807
STADA ARZNEIMITTEL AG
SE
List of nationally authorised medicinal products EMA/140794/2018
Page 152/220
Product Name (in authorisation country) Tramadol STADA® 100 mg Injektionslösung Tramadol STADA® 100 mg Retardtabletten Tramadol STADA® 100 mg Retardtabletten Tramadol STADA® 100 mg Zäpfchen Tramadol STADA® 100 mg/ml Tropfen zum Einnehmen, Lösung Tramadol STADA® 150 mg Retardtabletten Tramadol STADA® 150 mg Retardtabletten Tramadol STADA® 200 mg Retardtabletten Tramadol STADA® 200 mg Retardtabletten Tramadol STADA® 50 mg Hartkapseln Tramadol STADA® 50 mg Tabs Tramadol STADA® 50 mg Tabs TRAMADOL supozitoare 100 mg TRAMADOL SYNTEZA 100 mg/ml krople doustne TRAMADOL SYNTEZA 50 mg kapsułki twarde Tramadol Tarbis 100 mg comprimidos de liberación prolongada EFG
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0282/004
25036.00.00
STADAPHARM GMBH
DE
AT/H/0117/001
51845.00.00
STADAPHARM GMBH
DE
AT/H/0117/001
51845.00.00
STADAPHARM GMBH
DE
DE/H/0282/003
25037.00.00
STADAPHARM GMBH
DE
DE/H/0282/002
25038.00.00
STADAPHARM GMBH
DE
AT/H/0117/002
51845.01.00
STADAPHARM GMBH
DE
AT/H/0117/002
51845.01.00
STADAPHARM GMBH
DE
AT/H/0117/003
51845.02.00
STADAPHARM GMBH
DE
AT/H/0117/003
51845.02.00
STADAPHARM GMBH
DE
DE/H/0282/001
25035.00.00
STADAPHARM GMBH
DE
not available
37814.00.00
STADAPHARM GMBH
DE
not available
37814.00.00
STADAPHARM GMBH
DE
not available
2875/2002/01
KRKA, D.D., NOVO MESTO
RO
not available
R/2947
SYNTEZA SP. Z O.O.
PL
not available
R/2946
SYNTEZA SP. Z O.O.
PL
not available
65.800
TARBIS FARMA, S.L.
ES
List of nationally authorised medicinal products EMA/140794/2018
Page 153/220
Product Name (in authorisation country) Tramadol Tarbis 150 mg comprimidos de liberación prolongada EFG Tramadol Tarbis 200 mg comprimidos de liberación prolongada EFG TRAMADOL TEVA 50 mg, comprimé TRAMADOL TEVA 50 mg, comprimé effervescent TRAMADOL TEVA 50 mg, gélule TRAMADOL TEVA L.P. 100 mg, comprimé pelliculé à libération prolongée TRAMADOL TEVA L.P. 200 mg, comprimé pelliculé à libération prolongée Tramadol Teva LP 150 mg, comprimé pelliculé à libération prolongée Tramadol UNO Sandoz 200 mg tabletten met verlengde afgifte Tramadol VIR 100 mg/ml gotas orales en solución EFG Tramadol Vitabalans 50 mg tablete Tramadol Vitabalans 50 mg tablete Tramadol Vitabalans 50 mg tablete Tramadol Vitabalans 50 mg tablete Tramadol Vitabalans 50 mg tabletes
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
65.801
TARBIS FARMA, S.L.
ES
not available
65.408
TARBIS FARMA, S.L.
ES
not available
NL25151
TEVA SANTÉ
FR
not available
NL24341
TEVA SANTÉ
FR
not available
NL25606
TEVA SANTÉ
FR
not available
NL38989
TEVA SANTÉ
FR
not available
NL39007
TEVA SANTÉ
FR
not available
NL39006
TEVA SANTÉ
FR
DE/H/0576/001
BE296651
SANDOZ N.V.
BE
not available
72399
ES
FI/H/0779/001
H/13/01554/004
INDUSTRIA QUÍMICA Y FARMACÉUTICA VIR, S.A. VITABALANS OY
FI/H/0779/001
H/13/01554/003
VITABALANS OY
SI
FI/H/0779/001
H/13/01554/002
VITABALANS OY
SI
FI/H/0779/001
H/13/01554/001
VITABALANS OY
SI
FI/H/0779/001
12-0309
VITABALANS OY
LV
List of nationally authorised medicinal products EMA/140794/2018
SI
Page 154/220
Product Name (in authorisation country) Tramadol Vitabalans tabletės Tramadol Vitabalans tabletės Tramadol Vitabalans tabletės Tramadol Vitabalans tabletės Tramadol Vitabalans tabletės Tramadol Vitabalans tabletės Tramadol Vitabalans tabletės Tramadol Vitabalans tabletės Tramadol Vitabalans tabletės Tramadol Vitabalans tabletės Tramadol Vitabalans tabletės Tramadol Vitabalans tabletės Tramadol Vitabalans tabletės Tramadol Vitabalans tabletit Tramadol Vitabalans tabletta Tramadol Vitabalans tabletta Tramadol Vitabalans tabletta Tramadol Vitabalans tabletta
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
50 mg
FI/H/0779/001
LT/1/13/3221/001
VITABALANS OY
LT
50 mg
FI/H/0779/001
LT/1/13/3221/002
VITABALANS OY
LT
50 mg
FI/H/0779/001
LT/1/13/3221/003
VITABALANS OY
LT
50 mg
FI/H/0779/001
LT/1/13/3221/004
VITABALANS OY
LT
50 mg
FI/H/0779/001
LT/1/13/3221/005
VITABALANS OY
LT
50 mg
FI/H/0779/001
LT/1/13/3221/006
VITABALANS OY
LT
50 mg
FI/H/0779/001
LT/1/13/3221/007
VITABALANS OY
LT
50 mg
FI/H/0779/001
LT/1/13/3221/008
VITABALANS OY
LT
50 mg
FI/H/0779/001
LT/1/13/3221/009
VITABALANS OY
LT
50 mg
FI/H/0779/001
LT/1/13/3221/010
VITABALANS OY
LT
50 mg
FI/H/0779/001
LT/1/13/3221/011
VITABALANS OY
LT
50 mg
FI/H/0779/001
LT/1/13/3221/012
VITABALANS OY
LT
50 mg
FI/H/0779/001
LT/1/13/3221/013
VITABALANS OY
LT
50 mg
FI/H/0779/001
30017
VITABALANS OY
FI
50 mg
FI/H/0779/001
OGYI-T-22315/01
VITABALANS OY
HU
50 mg
FI/H/0779/001
OGYI-T-22315/02
VITABALANS OY
HU
50 mg
FI/H/0779/001
OGYI-T-22315/03
VITABALANS OY
HU
50 mg
FI/H/0779/001
OGYI-T-22315/04
VITABALANS OY
HU
List of nationally authorised medicinal products EMA/140794/2018
Page 155/220
Product Name (in authorisation country) Tramadol Vitabalans 50 mg tabletter Tramadol Vitabalans 50 mg tabletter Tramadol Vitabalans 50 mg tablety Tramadol Vitabalans 50 mg tablety Tramadol Vitabalans, 50 mg tabletid Tramadol Vitabalans, 50 mg, tabletki Tramadol Xantis 100 mg tablety Tramadol Xantis 50 mg kapsuly Tramadol Xantis 50 mg tvrdé tobolky TRAMADOL ZENTIVA 50 mg, comprimé effervescent TRAMADOL ZENTIVA 50 mg, comprimé effervescent TRAMADOL ZENTIVA 50 mg, comprimé effervescent TRAMADOL ZENTIVA LP 100 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 100 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 100 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 100 mg, comprimé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FI/H/0779/001
11-8528
VITABALANS OY
NO
FI/H/0779/001
46613
VITABALANS OY
SE
FI/H/0779/001
65/045/13-C
VITABALANS OY
CZ
FI/H/0779/001
65/0395/13-S
VITABALANS OY
SK
FI/H/0779/001
796212
VITABALANS OY
EE
FI/H/0779/001
20718
VITABALANS OY
PL
not available
65/171/07-C
XANTIS PHARMA LIMITED
CZ
not available
65/0346/03-S
XANTIS PHARMA LIMITED
SK
not available
65/657/97-C
XANTIS PHARMA LIMITED
CZ
not available
561 779-7
SANOFI-AVENTIS FRANCE
FR
not available
561 780-5
SANOFI-AVENTIS FRANCE
FR
not available
367 488-0
SANOFI-AVENTIS FRANCE
FR
DE/H/1093/002
34009 382 276 0 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/002
34009 382 286 6 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/002
34009 382 277 7 2
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/002
34009 382 281 4 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 156/220
Product Name (in authorisation country) TRAMADOL ZENTIVA LP 100 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 100 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 100 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 100 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 100 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 100 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 100 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 100 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 100 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 100 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 150 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 150 mg, comprimé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/1093/002
34009 571 545 9 2
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/002
34009 382 283 7 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/002
34009 382 278 3 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/002
34009 382 284 3 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/002
34009 571 546 5 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/002
34009 382 275 4 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/002
34009 382 280 8 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/002
34009 382 282 0 5
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/002
34009 382 287 2 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/002
34009 382 274 8 2
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/003
34009 382 294 9 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/003
34009 382 299 0 5
LABORATOIRES GRÜNENTHAL S.A.S.
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 157/220
Product Name (in authorisation country) TRAMADOL ZENTIVA LP 150 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 150 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 150 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 150 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 150 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 150 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 150 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 150 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 150 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 150 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 150 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 150 mg, comprimé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/1093/003
34009 382 300 9 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/003
34009 382 298 4 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/003
34009 382 290 3 5
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/003
34009 382 288 9 2
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/003
34009 382 293 2 5
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/003
34009 382 297 8 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/003
34009 382 296 1 5
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/003
34009 571 548 8 2
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/003
34009 571 547 1 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/003
34009 382 289 5 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/003
34009 382 292 6 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/003
34009 382 295 5 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 158/220
Product Name (in authorisation country) TRAMADOL ZENTIVA LP 200 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 200 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 200 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 200 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 200 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 200 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 200 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 200 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 200 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 200 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 200 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 200 mg, comprimé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/1093/004
34009 382 301 5 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/004
34009 382 302 1 5
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/004
34009 382 306 7 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/004
34009 382 311 0 6
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/004
34009 571 549 4 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/004
34009 382 309 6 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/004
34009 382 303 8 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/004
34009 571 550 2 5
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/004
34009 382 304 4 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/004
34009 382 313 3 5
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/004
34009 382 307 3 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/004
34009 382 312 7 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 159/220
Product Name (in authorisation country) TRAMADOL ZENTIVA LP 200 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 200 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 50 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 50 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 50 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 50 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 50 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 50 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 50 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 50 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 50 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 50 mg, comprimé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/1093/004
34009 382 310 4 5
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/004
34009 382 305 0 5
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/001
34009 382 272 5 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/001
34009 382 265 9 1
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/001
34009 382 269 4 2
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/001
34009 571 544 2 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/001
34009 382 263 6 2
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/001
34009 382 270 2 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/001
34009 382 268 8 1
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/001
34009 382 271 9 2
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/001
34009 382 261 3 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/001
34009 382 267 1 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 160/220
Product Name (in authorisation country) TRAMADOL ZENTIVA LP 50 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 50 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 50 mg, comprimé à libération prolongée TRAMADOL ZENTIVA LP 50 mg, comprimé à libération prolongée TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS 50 mg, gélule
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/1093/001
34009 571 543 6 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/001
34009 382 266 5 2
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/001
34009 382 273 1 4
LABORATOIRES GRÜNENTHAL S.A.S.
FR
DE/H/1093/001
34009 382 264 2 3
LABORATOIRES GRÜNENTHAL S.A.S.
FR
UK/H/0380/001
34009 357 126 9 1
ZYDUS FRANCE
FR
UK/H/0380/001
34009 357 127 5 2
ZYDUS FRANCE
FR
UK/H/0380/001
34009 357 128 1 3
ZYDUS FRANCE
FR
UK/H/0380/001
34009 357 129 8 1
ZYDUS FRANCE
FR
UK/H/0380/001
34009 357 131 2 4
ZYDUS FRANCE
FR
UK/H/0380/001
34009 563 492 7 2
ZYDUS FRANCE
FR
UK/H/0380/001
34009 563 493 3 3
ZYDUS FRANCE
FR
UK/H/0380/001
34009 357 132 9 2
ZYDUS FRANCE
FR
UK/H/0380/001
34009 357 133 5 3
ZYDUS FRANCE
FR
UK/H/0380/001
34009 357 134 1 4
ZYDUS FRANCE
FR
UK/H/0380/001
34009 357 135 8 2
ZYDUS FRANCE
FR
UK/H/0380/001
34009 357 136 4 3
ZYDUS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 161/220
Product Name (in authorisation country) TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS 50 mg, gélule TRAMADOL ZYDUS L.P. 100 mg, comprimé pelliculé à libération prolongée TRAMADOL ZYDUS L.P. 100 mg, comprimé pelliculé à libération prolongée TRAMADOL ZYDUS L.P. 100 mg, comprimé pelliculé à libération prolongée TRAMADOL ZYDUS L.P. 150 mg, comprimé pelliculé à libération prolongée TRAMADOL ZYDUS L.P. 150 mg, comprimé pelliculé à libération prolongée TRAMADOL ZYDUS L.P. 150 mg, comprimé pelliculé à libération prolongée TRAMADOL ZYDUS L.P. 150 mg, comprimé pelliculé à libération prolongée TRAMADOL ZYDUS L.P. 150 mg, comprimé pelliculé à libération prolongée
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0380/001
34009 357 137 0 4
ZYDUS FRANCE
FR
UK/H/0380/001
34009 563 495 6 2
ZYDUS FRANCE
FR
UK/H/0380/001
34009 563 496 2 3
ZYDUS FRANCE
FR
UK/H/0380/001
34009 576 208 0 6
ZYDUS FRANCE
FR
UK/H/0380/001
34009 357 130 6 3
ZYDUS FRANCE
FR
not available
34009 374 901 7 7
ZYDUS FRANCE
FR
not available
34009 374 902 3 8
ZYDUS FRANCE
FR
not available
34009 374 899 2 8
ZYDUS FRANCE
FR
not available
34009 394 144 7 8
ZYDUS FRANCE
FR
not available
34009 394 174 3 1
ZYDUS FRANCE
FR
not available
34009 394 176 6 0
ZYDUS FRANCE
FR
not available
34009 575 107 6 3
ZYDUS FRANCE
FR
not available
34009 575 108 2 4
ZYDUS FRANCE
FR
List of nationally authorised medicinal products EMA/140794/2018
Page 162/220
Product Name (in authorisation country) TRAMADOL ZYDUS L.P. 150 mg, comprimé pelliculé à libération prolongée TRAMADOL ZYDUS L.P. 200 mg, comprimé pelliculé à libération prolongée. TRAMADOL ZYDUS L.P. 200 mg, comprimé pelliculé à libération prolongée. TRAMADOL ZYDUS L.P. 200 mg, comprimé pelliculé à libération prolongée. TRAMADOL ZYDUS L.P. 200 mg, comprimé pelliculé à libération prolongée. TRAMADOL ZYDUS L.P. 200 mg, comprimé pelliculé à libération prolongée. TRAMADOL ZYDUS L.P. 200 mg, comprimé pelliculé à libération prolongée. Tramadol-CT 100 mg Retardkapseln Tramadol-CT 100 mg/ml Tropfen Tropfen zum Einnehmen, Lösung Tramadol-CT 150 mg Retardkapseln Tramadol-CT 200 mg Retardkapseln Tramadol-CT 50 mg Hartkapseln Tramadol-hameln 100 mg
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
34009 394 173 7 0
ZYDUS FRANCE
FR
not available
34009 394 177 2 1
ZYDUS FRANCE
FR
not available
34009 394 179 5 0
ZYDUS FRANCE
FR
not available
34009 394 180 3 2
ZYDUS FRANCE
FR
not available
34009 575 109 9 2
ZYDUS FRANCE
FR
not available
34009 575 110 7 4
ZYDUS FRANCE
FR
not available
34009 394 178 9 9
ZYDUS FRANCE
FR
not available
62755.00.00
ABZ-PHARMA GMBH
DE
not available
25527.00.00
ABZ-PHARMA GMBH
DE
not available
62756.00.00
ABZ-PHARMA GMBH
DE
not available
62756.01.00
ABZ-PHARMA GMBH
DE
not available
25527.00.01
ABZ-PHARMA GMBH
DE
ENR2138540
35342.01.00
HAMELN PHARMA PLUS GMBH
DE
List of nationally authorised medicinal products EMA/140794/2018
Page 163/220
Product Name (in authorisation country) Tramadolhydrochlorid Actavis 100 mg Retardtabletten Tramadolhydrochlorid Actavis 150 mg Retardtabletten Tramadolhydrochlorid Actavis 200 mg Retardtabletten Tramadolhydrochlorid G.L. 100 mg-Ampullen Tramadolhydrochlorid G.L. 100 mg-Zäpfchen Tramadolhydrochlorid G.L. 50 mg-Ampullen Tramadolhydrochlorid G.L. 50 mg-Filmtabletten Tramadolhydrochlorid G.L.Tropfen Tramadolhydrochlorid Lannacher retard 100 mgFilmtabletten Tramadolhydrochlorid Lannacher retard 100 mgFilmtabletten Tramadolhydrochlorid Lannacher retard 150 mgFilmtabletten Tramadolhydrochlorid Lannacher retard 150 mgFilmtabletten Tramadolhydrochlorid Lannacher retard 200 mgFilmtabletten
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0890/001
1-26983
ACTAVIS GROUP PTC EHF.
AT
NL/H/0890/002
1-26986
ACTAVIS GROUP PTC EHF.
AT
NL/H/0890/003
1-26987
ACTAVIS GROUP PTC EHF.
AT
not available
1-21803
G.L. PHARMA GMBH
AT
not available
1-21809
G.L. PHARMA GMBH
AT
not available
1-21801
G.L. PHARMA GMBH
AT
not available
1-21805
G.L. PHARMA GMBH
AT
not available
1-21807
G.L. PHARMA GMBH
AT
AT/H/0118/001
1-24188
G.L. PHARMA GMBH
AT
AT/H/0118/001
1070/03/02/0014
LANNACHER HEILMITTEL GES.M.B.H.,
LU
AT/H/0118/002
1-24186
G.L. PHARMA GMBH
AT
AT/H/0118/002
1070/03/02/0016
LANNACHER HEILMITTEL GES.M.B.H.,
LU
AT/H/0118/003
1-24187
G.L. PHARMA GMBH
AT
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Product Name (in authorisation country) Tramadolhydrochlorid Lannacher retard 200 mgFilmtabletten Tramadolhydrochloride capsules, capsules 50 mg Tramadolis SANITAS 50 mg/ml injekcinis/infuzinis tirpalas Tramadolis SANITAS 50 mg/ml injekcinis/infuzinis tirpalas TRAMADOLO HEXAL TRAMADOLO ABC 100 mg/ml gocce orali, soluzione TRAMADOLO ANGELINI, 100 mg supposte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
AT/H/0118/003
1070/03/02/0015
LANNACHER HEILMITTEL GES.M.B.H.,
LU
not available
RVG 18941
MEDA PHARMA B.V.
NL
not available
LT/1/2000/1577/001
PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
not available
LT/1/2000/1577/002
PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
LT
not available not available
033998 030 037941010
SANDOZ S.P.A. ABC FARMACEUTICI S.P.A.
IT IT
not available
035918059
IT
TRAMADOLO ANGELINI, 100 mg/2 ml soluzione iniettabile
not available
035918034
TRAMADOLO ANGELINI, 100mg/ml gocce orali, soluzione
not available
035918046
TRAMADOLO ANGELINI, 50 mg capsule rigide
not available
035918010
TRAMADOLO ANGELINI, 50 mg/ml soluzione iniettabile
not available
035918022
Tramadolo EG 100 mg soluzione iniettabile
DE/H/0282/004
035847096
AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A. AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A. AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A. AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A. AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO - A.C.R.A.F. S.P.A. EG S.P.A.
List of nationally authorised medicinal products EMA/140794/2018
IT
IT
IT
IT
IT
Page 165/220
Product Name (in authorisation country) Tramadolo EG 100 mg soluzione iniettabile Tramadolo EG 100 mg soluzione iniettabile Tramadolo EG 100 mg/ml gocce orali soluzione Tramadolo EG 100 mg/ml gocce orali soluzione Tramadolo EG 100 mg/ml gocce orali soluzione Tramadolo EG 100 mg/ml gocce orali soluzione Tramadolo EG 100 mg/ml gocce orali soluzione Tramadolo EG 100 mg/ml gocce orali soluzione Tramadolo EG 100 mg/ml gocce orali soluzione Tramadolo EG 50 mg capsule rigide Tramadolo EG 50 mg capsule rigide Tramadolo EG 50 mg capsule rigide Tramadolo EG 50 mg capsule rigide Tramadolo EG 50 mg capsule rigide Tramadolo EG 50 mg capsule rigide Tramadolo EG 50 mg capsule rigide Tramadolo EG 50 mg capsule rigide Tramadolo EG 50 mg capsule rigide
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0282/004
035847084
EG S.P.A.
IT
DE/H/0282/004
035847108
EG S.P.A.
IT
DE/H/0282/002
035847060
EG SPA
IT
DE/H/0282/002
035847021
EG SPA
IT
DE/H/0282/002
035847058
EG SPA
IT
DE/H/0282/002
035847072
EG SPA
IT
DE/H/0282/002
035847019
EG SPA
IT
DE/H/0282/002
035847033
EG SPA
IT
DE/H/0282/002
035847045
EG SPA
IT
DE/H/0282/001
035847185
EG SPA
IT
DE/H/0282/001
035847197
EG SPA
IT
DE/H/0282/001
035847247
EG SPA
IT
DE/H/0282/001
035847211
EG SPA
IT
DE/H/0282/001
035847223
EG SPA
IT
DE/H/0282/001
035847235
EG SPA
IT
DE/H/0282/001
035847250
EG SPA
IT
DE/H/0282/001
035847110
EG SPA
IT
DE/H/0282/001
035847146
EG SPA
IT
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Product Name (in authorisation country) Tramadolo EG 50 mg capsule rigide Tramadolo EG 50 mg capsule rigide Tramadolo EG 50 mg capsule rigide Tramadolo EG 50 mg capsule rigide Tramadolo EG 50 mg capsule rigide Tramadolo EG 50 mg capsule rigide Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0282/001
035847122
EG SPA
IT
DE/H/0282/001
035847209
EG SPA
IT
DE/H/0282/001
035847159
EG SPA
IT
DE/H/0282/001
035847173
EG SPA
IT
DE/H/0282/001
035847134
EG SPA
IT
DE/H/0282/001
035847161
EG SPA
IT
mg
NL/H/0538/001
037133042
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133067
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133079
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133081
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133093
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133105
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133117
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133129
GERMED PHARMA S.R.L.
IT
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Product Name (in authorisation country) Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato Tramadolo GERMED 100 compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
mg
NL/H/0538/001
037133319
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133321
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133333
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133345
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133358
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133360
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133372
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133384
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133396
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133408
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133055
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/001
037133016
GERMED PHARMA S.R.L.
IT
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Product Name (in authorisation country) Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
mg
NL/H/0538/002
037133143
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133156
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133168
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133170
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133182
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133194
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133206
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133218
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133410
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133422
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133434
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133446
GERMED PHARMA S.R.L.
IT
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Product Name (in authorisation country) Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 150 compresse a rilascio prolungato Tramadolo GERMED 200 compresse a rilascio prolungato Tramadolo GERMED 200 compresse a rilascio prolungato Tramadolo GERMED 200 compresse a rilascio prolungato Tramadolo GERMED 200 compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
mg
NL/H/0538/002
037133459
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133461
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133473
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133485
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133497
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133509
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133131
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/002
037133028
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/003
037133232
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/003
037133244
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/003
037133257
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/003
037133269
GERMED PHARMA S.R.L.
IT
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Product Name (in authorisation country) Tramadolo GERMED 200 compresse a rilascio prolungato Tramadolo GERMED 200 compresse a rilascio prolungato Tramadolo GERMED 200 compresse a rilascio prolungato Tramadolo GERMED 200 compresse a rilascio prolungato Tramadolo GERMED 200 compresse a rilascio prolungato Tramadolo GERMED 200 compresse a rilascio prolungato Tramadolo GERMED 200 compresse a rilascio prolungato Tramadolo GERMED 200 compresse a rilascio prolungato Tramadolo GERMED 200 compresse a rilascio prolungato Tramadolo GERMED 200 compresse a rilascio prolungato Tramadolo GERMED 200 compresse a rilascio prolungato Tramadolo GERMED 200 compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
mg
NL/H/0538/003
037133271
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/003
037133283
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/003
037133295
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/003
037133307
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/003
037133511
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/003
037133523
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/003
037133535
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/003
037133547
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/003
037133550
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/003
037133562
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/003
037133574
GERMED PHARMA S.R.L.
IT
mg
NL/H/0538/003
037133586
GERMED PHARMA S.R.L.
IT
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Product Name (in authorisation country) Tramadolo GERMED 200 mg compresse a rilascio prolungato Tramadolo GERMED 200 mg compresse a rilascio prolungato Tramadolo GERMED 200 mg compresse a rilascio prolungato Tramadolo GERMED 200 mg compresse a rilascio prolungato Tramadolo HCl Sandoz Tramadolo HCl Sandoz Tramadolo HCl Sandoz Tramadolo HCl Sandoz Tramadolo HCl Sandoz Tramadolo HCl Sandoz Tramadolo HCl Sandoz TRAMADOLO HEXAL 100 mg/ml gocce orali, soluzione TRAMADOLO HEXAL 50 mg capsule rigide Tramadolo Mylan 100 mg compresse a rilascio prolungato Tramadolo Mylan 100 mg compresse a rilascio prolungato Tramadolo Mylan 100 mg compresse a rilascio prolungato Tramadolo Mylan 100 mg compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0538/003
037133598
GERMED PHARMA S.R.L.
IT
NL/H/0538/003
037133600
GERMED PHARMA S.R.L.
IT
NL/H/0538/003
037133220
GERMED PHARMA S.R.L.
IT
NL/H/0538/003
037133030
GERMED PHARMA S.R.L.
IT
NL/H/0483/001 NL/H/0483/001 NL/H/0483/001 NL/H/0483/001 NL/H/0483/001 NL/H/0483/001 NL/H/0483/001 not available
036697023 036697047 036697011 036697035 036697050 036697074 036697062 033998055
SANDOZ SANDOZ SANDOZ SANDOZ SANDOZ SANDOZ SANDOZ SANDOZ
S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A. S.P.A.
IT IT IT IT IT IT IT IT
not available
033998016
SANDOZ S.P.A.
IT
UK/H/4160/001
040976211
MYLAN S.P.A.
IT
UK/H/4160/001
040976209
MYLAN S.P.A.
IT
UK/H/4160/001
040976173
MYLAN S.P.A.
IT
UK/H/4160/001
040976185
MYLAN S.P.A.
IT
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Product Name (in authorisation country) Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
mg
UK/H/4160/001
040976161
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976197
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976134
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976146
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976096
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976159
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976122
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976108
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976110
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976084
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976072
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976060
MYLAN S.P.A.
IT
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Product Name (in authorisation country) Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 100 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
mg
UK/H/4160/001
040976033
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976019
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976045
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976021
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976058
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976641
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976654
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976704
MYLAN S.P.A.
IT
mg
UK/H/4160/001
040976716
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976425
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976413
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976399
MYLAN S.P.A.
IT
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Product Name (in authorisation country) Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
mg
UK/H/4160/002
040976387
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976401
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976375
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976351
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976363
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976348
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976336
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976312
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976247
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976250
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976300
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976298
MYLAN S.P.A.
IT
List of nationally authorised medicinal products EMA/140794/2018
Page 175/220
Product Name (in authorisation country) Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 150 compresse a rilascio prolungato Tramadolo Mylan 200 compresse a rilascio prolungato Tramadolo Mylan 200 compresse a rilascio prolungato Tramadolo Mylan 200 compresse a rilascio prolungato Tramadolo Mylan 200 compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
mg
UK/H/4160/002
040976274
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976262
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976223
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976235
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976666
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976678
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976728
MYLAN S.P.A.
IT
mg
UK/H/4160/002
040976730
MYLAN S.P.A.
IT
mg
UK/H/4160/003
040976639
MYLAN S.P.A.
IT
mg
UK/H/4160/003
040976615
MYLAN S.P.A.
IT
mg
UK/H/4160/003
040976603
MYLAN S.P.A.
IT
mg
UK/H/4160/003
040976627
MYLAN S.P.A.
IT
List of nationally authorised medicinal products EMA/140794/2018
Page 176/220
Product Name (in authorisation country) Tramadolo Mylan 200 compresse a rilascio prolungato Tramadolo Mylan 200 compresse a rilascio prolungato Tramadolo Mylan 200 compresse a rilascio prolungato Tramadolo Mylan 200 compresse a rilascio prolungato Tramadolo Mylan 200 compresse a rilascio prolungato Tramadolo Mylan 200 compresse a rilascio prolungato Tramadolo Mylan 200 compresse a rilascio prolungato Tramadolo Mylan 200 compresse a rilascio prolungato Tramadolo Mylan 200 compresse a rilascio prolungato Tramadolo Mylan 200 compresse a rilascio prolungato Tramadolo Mylan 200 compresse a rilascio prolungato Tramadolo Mylan 200 compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
mg
UK/H/4160/003
040976591
MYLAN S.P.A.
IT
mg
UK/H/4160/003
040976589
MYLAN S.P.A.
IT
mg
UK/H/4160/003
040976565
MYLAN S.P.A.
IT
mg
UK/H/4160/003
040976577
MYLAN S.P.A.
IT
mg
UK/H/4160/003
040976553
MYLAN S.P.A.
IT
mg
UK/H/4160/003
040976540
MYLAN S.P.A.
IT
mg
UK/H/4160/003
040976538
MYLAN S.P.A.
IT
mg
UK/H/4160/003
040976514
MYLAN S.P.A.
IT
mg
UK/H/4160/003
040976526
MYLAN S.P.A.
IT
mg
UK/H/4160/003
040976502
MYLAN S.P.A.
IT
mg
UK/H/4160/003
040976490
MYLAN S.P.A.
IT
mg
UK/H/4160/003
040976488
MYLAN S.P.A.
IT
List of nationally authorised medicinal products EMA/140794/2018
Page 177/220
Product Name (in authorisation country) Tramadolo Mylan 200 mg compresse a rilascio prolungato Tramadolo Mylan 200 mg compresse a rilascio prolungato Tramadolo Mylan 200 mg compresse a rilascio prolungato Tramadolo Mylan 200 mg compresse a rilascio prolungato Tramadolo Mylan 200 mg compresse a rilascio prolungato Tramadolo Mylan 200 mg compresse a rilascio prolungato Tramadolo Mylan 200 mg compresse a rilascio prolungato Tramadolo Mylan 200 mg compresse a rilascio prolungato Tramadolo Mylan 200 mg compresse a rilascio prolungato TRAMADOLO VIATRIS 100 mg/ml gocce orali, soluzione TRAMADOLO VIATRIS 100 mg/ml gocce orali, soluzione TRAMADOLO VIATRIS 100 mg/ml gocce orali, soluzione TRAMADOLO VIATRIS 100 mg/ml gocce orali, soluzione
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/4160/003
040976476
MYLAN S.P.A.
IT
UK/H/4160/003
040976464
MYLAN S.P.A.
IT
UK/H/4160/003
040976437
MYLAN S.P.A.
IT
UK/H/4160/003
040976452
MYLAN S.P.A.
IT
UK/H/4160/003
040976449
MYLAN S.P.A.
IT
UK/H/4160/003
040976680
MYLAN S.P.A.
IT
UK/H/4160/003
040976692
MYLAN S.P.A.
IT
UK/H/4160/003
040976742
MYLAN S.P.A.
IT
UK/H/4160/003
040976755
MYLAN S.P.A.
IT
DE/H/0306/003
035875020
MEDA PHARMA S.P.A.
IT
DE/H/0306/003
035875018
MEDA PHARMA S.P.A.
IT
DE/H/0306/003
035875032
MEDA PHARMA S.P.A.
IT
DE/H/0306/003
035875044
MEDA PHARMA S.P.A.
IT
List of nationally authorised medicinal products EMA/140794/2018
Page 178/220
Product Name (in authorisation country) TRAMADOLO VIATRIS 100 mg/ml gocce orali, soluzione TRAMADOLO VIATRIS 50 mg capsule rigide TRAMADOLO VIATRIS 50 mg capsule rigide TRAMADOLO VIATRIS 50 mg capsule rigide TRAMADOLO VIATRIS 50 mg capsule rigide TRAMADOLO VIATRIS 50 mg/ml soluzione iniettabile TRAMADOLO VIATRIS 50 mg/ml soluzione iniettabile TRAMADOLO VIATRIS 50 mg/ml soluzione iniettabile TRAMADOLOR 100 ID comprimate cu eliberare modificată TRAMADOLOR 100 ID comprimate cu eliberare modificată Tramadolor 100 mg Ampullen Tramadolor 100 mg módosított hatóanyagleadású tabletta Tramadolor 100 mg módosított hatóanyagleadású tabletta Tramadolor 100 mg/ml Tropfen Tramadolor 150 mg módosított hatóanyagleadású tabletta
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0306/003
035875057
MEDA PHARMA S.P.A.
IT
DE/H/0306/001
035875095
MEDA PHARMA S.P.A.
IT
DE/H/0306/001
035875107
MEDA PHARMA S.P.A.
IT
DE/H/0306/001
035875121
MEDA PHARMA S.P.A.
IT
DE/H/0306/001
035875119
MEDA PHARMA S.P.A.
IT
DE/H/0306/002
035875071
MEDA PHARMA S.P.A.
IT
DE/H/0306/002
035875069
MEDA PHARMA S.P.A.
IT
DE/H/0306/002
035875083
MEDA PHARMA S.P.A.
IT
not available
3763/2003/01
HEXAL AG
RO
not available
3763/2003/02
HEXAL AG
RO
not available
1-23700
HEXAL PHARMA GMBH
AT
not available
OGYI-T-8179/01
SANDOZ HUNGÁRIA KFT
HU
not available
OGYI-T-8179/02
SANDOZ HUNGÁRIA KFT
HU
not available
1-23701
HEXAL PHARMA GMBH
AT
not available
OGYI-T-8179/09
SANDOZ HUNGÁRIA KFT
HU
List of nationally authorised medicinal products EMA/140794/2018
Page 179/220
Product Name (in authorisation country) Tramadolor 150 mg módosított hatóanyagleadású tabletta Tramadolor 200 mg módosított hatóanyagleadású tabletta Tramadolor 200 mg módosított hatóanyagleadású tabletta Tramadolor 50 mg - Kapseln Tramadolor 50 mg kemény kapszula Tramadolor 50 mg kemény kapszula Tramadolor einmal täglich 100 mg Retardtabletten Tramadolor einmal täglich 100 mg Retardtabletten Tramadolor einmal täglich 200 mg Retardtabletten Tramadolor einmal täglich 200 mg Retardtabletten Tramadolor einmal täglich 300 mg Retardtabletten Tramadolor einmal täglich 300 mg Retardtabletten Tramadolor ID 200 mg modifikuoto atpalaidavimo tabletės Tramadolor ID 200 mg modifikuoto atpalaidavimo tabletės Tramadolor ID 200 mg modifikuoto atpalaidavimo tabletės
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
OGYI-T-8179/08
SANDOZ HUNGÁRIA KFT
HU
not available
OGYI-T-8179/06
SANDOZ HUNGÁRIA KFT
HU
not available
OGYI-T-8179/05
SANDOZ HUNGÁRIA KFT
HU
not available not available
1-23708 OGYI-T-8179/03
HEXAL PHARMA GMBH SANDOZ HUNGÁRIA KFT
AT HU
not available
OGYI-T-8179/04
SANDOZ HUNGÁRIA KFT
HU
FR/H/0272/001
63147.00.00
HEXAL AG
DE
FR/H/0272/001
63147.00.00
HEXAL AG
DE
FR/H/0272/002
63148.00.00
HEXAL AG
DE
FR/H/0272/002
63148.00.00
HEXAL AG
DE
FR/H/0272/003
63149.00.00
HEXAL AG
DE
FR/H/0272/003
63149.00.00
HEXAL AG
DE
not available
LT/1/99/0247/011
SANDOZ PHARMACEUTICALS D.D.
LT
not available
LT/1/99/0247/013
SANDOZ PHARMACEUTICALS D.D.
LT
not available
LT/1/99/0247/012
SANDOZ PHARMACEUTICALS D.D.
LT
List of nationally authorised medicinal products EMA/140794/2018
Page 180/220
Product Name (in authorisation country) Tramadolor ID 100 mg modifikuoto atpalaidavimo tabletės Tramadolor ID 100 mg modifikuoto atpalaidavimo tabletės Tramadolor ID 150 mg modifikuoto atpalaidavimo tabletės Tramadolor ID 150 mg modifikuoto atpalaidavimo tabletės Tramadolor ID 150 mg modifikuoto atpalaidavimo tabletės Tramadolor retard 100 mg Tabletten Tramadolor retard 100 mg tablete Tramadolor retard 150 mg Tabletten Tramadolor retard 150 mg tablete Tramadolor retard 200 mg Tabletten Tramadolor retard 200 mg tablete Tramadolor® 100 injekt Tramadolor® 100 mg Brause Tramadolor® 100 mg ID Tramadolor® 100 mg/ml Lösung, Tropfen zum Einnehmen, Lösung Tramadolor® 150 mg ID Tramadolor® 200 mg ID
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
LT/1/99/0247/002
SANDOZ PHARMACEUTICALS D.D.
LT
not available
LT/1/99/0247/003
SANDOZ PHARMACEUTICALS D.D.
LT
not available
LT/1/99/0247/008
SANDOZ PHARMACEUTICALS D.D.
LT
not available
LT/1/99/0247/009
SANDOZ PHARMACEUTICALS D.D.
LT
not available
LT/1/99/0247/010
SANDOZ PHARMACEUTICALS D.D.
LT
DE/H/0288/001
1-24377
HEXAL PHARMA GMBH
AT
/
HR-H-835899381
SANDOZ D.O.O.
HR
DE/H/0288/002
1-24382
HEXAL PHARMA GMBH
AT
/
HR-H-008744405
SANDOZ D.O.O.
HR
DE/H/0288/003
1-24383
HEXAL PHARMA GMBH
AT
/
HR-H-026332681
SANDOZ D.O.O.
HR
not available not available
6137845.01.00 37201.01.00
HEXAL AG HEXAL AG
DE DE
DE/H/0448/001 not available
11558.00.00 6301608.00.00
HEXAL AG HEXAL AG
DE DE
DE/H/0448/002 DE/H/0448/003
45017.01.00 45017.02.00
HEXAL AG HEXAL AG
DE DE
List of nationally authorised medicinal products EMA/140794/2018
Page 181/220
Product Name (in authorisation country) Tramadolor® 50 injekt Tramadolor® Kapseln Tramadolor® long 100 mg Hartkapseln, retardiert Tramadolor® long 150 mg Hartkapseln, retardiert Tramadolor® long 200 mg Hartkapseln, retardiert Tramadolor® long 50 mg Hartkapseln, retardiert Tramadolor® tabs Tramadol-Q® 100 mg Retardtabletten Tramadol-Q® 150 mg Retardtabletten Tramadol-Q® 200 mg Retardtabletten Tramadol-ratiopharm® 100 mg Retardtabletten Tramadol-ratiopharm® 100 mg/2 ml Injektionslösung Tramadol-ratiopharm® 100 mg/ml Tropfen Tropfen zum Einnehmen, Lösung Tramadol-ratiopharm® 150 mg Retardkapseln Tramadol-ratiopharm® 200 mg Retardkapseln Tramadol-ratiopharm® 50 mg Hartkapseln Tramadol-ratiopharm® 50 mg Retardkapseln Tramadol-ratiopharm® 50 mg/ml Injektionslösung Tramadol-saar 100 mg Ampulle
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available not available not available
35345.00.00 32747.00.02 42433.01.00
HEXAL AG HEXAL AG HEXAL AG
DE DE DE
not available
42433.02.00
HEXAL AG
DE
not available
42433.03.00
HEXAL AG
DE
not available
42433.00.00
HEXAL AG
DE
not available NL/H/0888/001
6584337.00.00 67444.00.00
HEXAL AG JUTA PHARMA GMBH
DE DE
NL/H/0888/002
67445.00.00
JUTA PHARMA GMBH
DE
NL/H/0888/003/MR
67446.00.00
JUTA PHARMA GMBH
DE
not available
39925.00.00
RATIOPHARM GMBH
DE
not available
6025891.00.00
RATIOPHARM GMBH
DE
not available
31467.00.00
RATIOPHARM GMBH
DE
not available
54390.02.00
RATIOPHARM GMBH
DE
not available
54390.03.00
RATIOPHARM GMBH
DE
not available
31518.00.00
RATIOPHARM GMBH
DE
not available
54390.00.00
RATIOPHARM GMBH
DE
not available
32305.00.00
RATIOPHARM GMBH
DE
not available
32285.00.00
MIP PHARMA GMBH
DE
List of nationally authorised medicinal products EMA/140794/2018
Page 182/220
Product Name (in authorisation country) Tramadol-saar 50 mg Ampulle Tramadol-Sandoz 100 mg / ml Tropfen zum Einnehmen, Lösung Tramadol-Sandoz 100 mg Retardtabletten Tramadol-Sandoz 150 mg Retardtabletten Tramadol-Sandoz 200 mg Retardtabletten Tramadura Injekt Wirkstoff: Tramadolhydrochlorid Tramag 50 Tramagetic OD 150 mg depottabletter Tramagetic OD 200 mg depottabletter Tramagetic OD 300 mg depottabletter TRAMAGETIC Once-Daily 150 mg tabletten TRAMAGETIC Once-Daily 200 tabletten TRAMAGETIC Once-Daily 300 tabletten TRAMAGETIC Once-Daily 400 mg tabletten Tramagetic Retard 100 mg depottabletter TRAMAGETIC RETARD 100 mg tabletten Tramagetic Retard 150 mg depottabletter TRAMAGETIC RETARD 150 mg tabletten
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
35344.00.00
MIP PHARMA GMBH
DE
not available
30508.00.00
HEXAL AG
DE
NL/H/0483/001
60258.00.00
HEXAL AG
DE
NL/H/0483/002
60258.01.00
HEXAL AG
DE
NL/H/0483/003
60258.02.00
HEXAL AG
DE
not available
38502.00.00
MYLAN DURA GMBH
DE
not available not available
5892/2005/01 99-7688
MAGISTRA C&C MUNDIPHARMA AS.
RO NO
not available
99-7689
MUNDIPHARMA AS.
NO
not available
99-7690
MUNDIPHARMA AS.
NO
not available
RVG 22232
not available
RVG 22233
not available
RVG 22234
not available
RVG 22235
not available
99-7782
MUNDIPHARMA PHARMACEUTICALS MUNDIPHARMA PHARMACEUTICALS MUNDIPHARMA PHARMACEUTICALS MUNDIPHARMA PHARMACEUTICALS MUNDIPHARMA AS.
not available
RVG 22452
not available
99-7783
not available
RVG 22453
List of nationally authorised medicinal products EMA/140794/2018
BV BV BV BV
NL NL NL NL NO
MUNDIPHARMA PHARMACEUTICALS BV MUNDIPHARMA AS.
NL
MUNDIPHARMA PHARMACEUTICALS BV
NL
NO
Page 183/220
Product Name (in authorisation country) Tramagetic Retard 200 mg depottabletter TRAMAGETIC RETARD 200 mg tabletten Tramagetic Retard 75 mg depottabletter TRAMAGETIC RETARD 75 mg tabletten Tramagit 100 mg otopina za injekcije Tramagit 50 mg otopina za injekcije Tramagit® 100 mg Retardtabletten Tramagit® 100 mg/ml Lösung zum Einnehmen Tramagit® 150 mg Retardtabletten Tramagit® 200 mg Retardtabletten Tramagit® 50 mg Tabletten
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
99-7784
MUNDIPHARMA AS.
NO
not available
RVG 22454
NL
not available
99-7781
MUNDIPHARMA PHARMACEUTICALS BV MUNDIPHARMA AS.
not available
RVG 22451
NL
not available
HR-H-237941754
MUNDIPHARMA PHARMACEUTICALS BV FARMAL DD.
not available
HR-H-576551176
FARMAL DD.
HR
not available
39924.00.00
DE
not available
29737.00.01
not available
79350.00.00
not available
79351.00.00
not available
29737.00.00
Tramagit® 50 mg/ml Injektionslösung Tramagit® Tabletten 50 mg TRAMAKE 100mg Tablets TRAMAKE 100mg Tablets TRAMAKE 50mg Tablets TRAMAKE 50mg Tablets Tramal 100 mg ilgstošās darbības tabletes Tramal 100 mg otopina za injekcije Tramal 100 mg supozitoriji Tramal 100 mg svečke
not available
34981.00.00
not available
6140209.00.00
not not not not not
PA 1329/4/2 PA 1329/4/2 PA 1329/4/1 PA 1329/4/1 99-0530
KREWEL MEUSELBACH GMBH KREWEL MEUSELBACH GMBH KREWEL MEUSELBACH GMBH KREWEL MEUSELBACH GMBH KREWEL MEUSELBACH GMBH KREWEL MEUSELBACH GMBH KREWEL MEUSELBACH GMBH GALEN LIMITED GALEN LIMITED GALEN LIMITED GALEN LIMITED STADA ARZNEIMITTEL AG
not available
UP/I-530-09/09-02/91
STADA D.O.O.
HR
not available not available
99-0529 H/92/01556/007
STADA ARZNEIMITTEL AG STADA ARZNEIMITTEL AG
LV SI
available available available available available
List of nationally authorised medicinal products EMA/140794/2018
NO
HR
DE DE DE DE DE DE IE IE IE IE LV
Page 184/220
Product Name (in authorisation country) Tramal 100 mg tablete s produljenim oslobadanjem Tramal 100 mg, Injektionslösung Tramal 100 mg, Injektionslösung Tramal 100 mg/2 ml solução injectável Tramal 100 mg/ml gotas orais, solução Tramal 100 mg/ml gotas orais, solução Tramal 100 mg/ml gotas orais, solução Tramal 100 mg/ml Lösung zum Einnehmen Tramal 100 mg/ml orala droppar, lösning i doseringspumpflaskan Tramal 100 mg/ml oralne kapi Tramal 100 mg/ml peroralne kapljice, raztopina v kapalnem vsebniku Tramal 100 mg/ml peroralne kapljice, raztopina v steklenici z odmerno črpalko Tramal 100 mg/ml pilieni iekškigai lietošanai, škidums pudele ar dozešanas sukni Tramal 100 mg/ml pilieni iekškigai lietošanai, škidums pudele ar pilinataju Tramal 100 mg/ml tipat, liuos
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
HR-H-61 0358597
STADA D.O.O.
HR
not available
1116.00.02
GRÜNENTHAL GMBH
DE
not available
120/88/06/0250
GRÜNENTHAL GMBH
LU
not available
8565002
GRÜNENTHAL S.A.
PT
not available
3081288
GRÜNENTHAL S.A.
PT
not available
8740605
GRÜNENTHAL S.A.
PT
not available
2710085
GRÜNENTHAL S.A.
PT
not available
1116.00.01
GRÜNENTHAL GMBH
DE
not available
12688
ORION OYJ
FI
not available
UP/I-530-09/09-02/92
STADA D.O.O
HR
not available
H/92/01556/005
STADA ARZNEIMITTEL AG
SI
not available
H/92/01556/006
STADA ARZNEIMITTEL AG
SI
not available
13-0057
STADA ARZNEIMITTEL AG
LV
not available
99-0528
STADA ARZNEIMITTEL AG
LV
not available
12688
ORION OYJ
FI
List of nationally authorised medicinal products EMA/140794/2018
Page 185/220
Product Name (in authorisation country) Tramal 100, oplossing voor injectie 100 mg/2 ml TRAMAL 150 mg ilgstošās darbības tabletes Tramal 150 mg tablete s produljenim oslobadanjem TRAMAL 200 mg ilgstošās darbības tabletes Tramal 200 mg tablete s produljenim oslobadanjem Tramal 50 mg cápsulas Tramal 50 mg cápsulas TRAMAL 50 mg cietās kapsulas Tramal 50 mg filmsko obložene tablete s podaljšanim sproščanjem Tramal 50 mg filmsko obložene tablete s podaljšanim sproščanjem Tramal 50 mg filmsko obložene tablete s podaljšanim sproščanjem Tramal 50 mg filmsko obložene tablete s podaljšanim sproščanjem Tramal 50 mg hårda kapslar Tramal 50 mg kapseli, kova Tramal 50 mg kapsule Tramal 50 mg liukeneva tabletti Tramal 50 mg otopina za injekcije Tramal 50 mg tablete s produljenim oslobadanjem Tramal 50 mg trde kapsule
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
RVG 15510
GRÜNENTHAL B.V.
NL
not available
99-0531
STADA ARZNEIMITTEL AG
LV
not available
HR-H-170945872
STADA D.O.O.
HR
not available
99-0532
STADA ARZNEIMITTEL AG
LV
not available
HR-H-505350700
STADA D.O.O.
HR
not available not available not available
8565119 8565101 99-0527
GRÜNENTHAL S.A. GRÜNENTHAL S.A. STADA ARZNEIMITTEL AG
PT PT LV
DE/H/0108/004
5363-I-637/13
STADA ARZNEIMITTEL AG
SI
DE/H/0108/004
5363-I-637/13
STADA ARZNEIMITTEL AG
SI
DE/H/0108/004
5363-I-637/13
STADA ARZNEIMITTEL AG
SI
DE/H/0108/004
5363-I-637/13
STADA ARZNEIMITTEL AG
SI
not not not not
available available available available
11453 11453 UP/I-530-09/09-02/89 13245
ORION ORION STADA ORION
OYJ OYJ D.O.O OYJ
FI FI HR FI
not available
UP/I-530-09/09-02/90
STADA D.O.O
HR
not available
HR-H-21 0396637
STADA D.O.O.
HR
not available
H/92/01556/004
STADA ARZNEIMITTEL AG
SI
List of nationally authorised medicinal products EMA/140794/2018
Page 186/220
Product Name (in authorisation country) Tramal 50 mg upplösliga tabletter Tramal 50 mg, Injektionslösung Tramal 50 mg/ml injektioneste, liuos Tramal 50 mg/ml injektionsvätska, lösning Tramal 50 mg/ml raztopina za injiciranje/infundiranje Tramal 50 mg/ml raztopina za injiciranje/infundiranje Tramal 50 mg/ml škidums injekcijam TRAMAL čapíky 100 mg TRAMAL čípky 100 mg TRAMAL injekční roztok 100 mg/2 ml TRAMAL injekcní roztok 50 mg/1 ml TRAMAL injekčný roztok 100 mg/2 ml TRAMAL injekčný roztok 50 mg/ml TRAMAL kapky 100 mg/1 ml Tramal Kapseln, 50 mg, Hartkapseln Tramal Kapseln, 50 mg, Hartkapseln TRAMAL kapsuly 50 mg TRAMAL kvapky 100 mg/ml Tramal long 100 mg Retardtabletten Tramal long 100 mg Retardtabletten
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
13245
ORION OYJ
FI
not available
1116.01.02
GRÜNENTHAL GMBH
DE
not available
11452
ORION OYJ
FI
not available
11452
ORION OYJ
FI
not available
H/92/01556/008
STADA ARZNEIMITTEL AG
SI
not available
H/92/01556/009
STADA ARZNEIMITTEL AG
SI
not available
96-0105
STADA ARZNEIMITTEL AG
LV
not available not available not available
65/0076/91-S 65/076/91-S/C 65/079/91-S/C
STADA ARZNEIMITTEL AG STADA ARZNEIMITTEL AG STADA ARZNEIMITTEL AG
SK CZ CZ
not available
65/078/91-S/C
STADA ARZNEIMITTEL AG
CZ
not available
65/0079/91-S
STADA ARZNEIMITTEL AG
SK
not available
65/0078/91-S
STADA ARZNEIMITTEL AG
SK
not available not available
65/077/91-S/C 1116.00.00
STADA ARZNEIMITTEL AG GRÜNENTHAL GMBH
CZ DE
not available
120/88/06/0249
GRÜNENTHAL GMBH
LU
not available not available not available
65/0075/91-S 65/0077/91-S 120/95/12/0413
STADA ARZNEIMITTEL AG STADA ARZNEIMITTEL AG GRÜNENTHAL GMBH
SK SK LU
DE/H/0798/002
37294.00.00
GRÜNENTHAL GMBH
DE
List of nationally authorised medicinal products EMA/140794/2018
Page 187/220
Product Name (in authorisation country) Tramal long 150 mg Retardtabletten Tramal long 150 mg Retardtabletten Tramal long 200 mg Retardtabletten Tramal long 200 mg Retardtabletten Tramal long 50 mg Retardtabletten Tramal retard 100 mg comprimidos de libertação prolongada Tramal retard 100 mg comprimidos de libertação prolongada Tramal retard 100 mg comprimidos de libertação prolongada Tramal retard 100 mg comprimidos de libertação prolongada Tramal retard 100 mg comprimidos de libertação prolongada Tramal retard 100 mg comprimidos de libertação prolongada Tramal retard 100 mg comprimidos de libertação prolongada Tramal retard 100 mg comprimidos de libertação prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
0120/97/04/0280
GRÜNENTHAL GMBH
LU
DE/H/0798/003
37294.01.00
GRÜNENTHAL GMBH
DE
DE/H/0798/004
37294.02.00
GRÜNENTHAL GMBH
DE
not available
0120/97/04/0282
GRÜNENTHAL GMBH
LU
DE/H/0798/001
60444.00.00
GRÜNENTHAL GMBH
DE
DE/H/0108/001
2971984
GRÜNENTHAL S.A.
PT
DE/H/0108/001
2511186
GRÜNENTHAL S.A.
PT
DE/H/0108/001
5419486
GRÜNENTHAL S.A.
PT
DE/H/0108/001
2971984
GRÜNENTHAL S.A.
PT
DE/H/0108/001
2511186
GRÜNENTHAL S.A.
PT
DE/H/0108/001
5419486
GRÜNENTHAL S.A.
PT
DE/H/0108/001
2971984
GRÜNENTHAL S.A.
PT
DE/H/0108/001
2511186
GRÜNENTHAL S.A.
PT
List of nationally authorised medicinal products EMA/140794/2018
Page 188/220
Product Name (in authorisation country) Tramal retard 100 mg comprimidos de libertação prolongada Tramal retard 100 mg depottabletti Tramal retard 100 mg depottabletti Tramal retard 100 mg depottabletti TRAMAL RETARD 100 mg toimeainet prolongeeritult vabastavad tabletid TRAMAL RETARD 100 mg, comprimate cu eliberare prelungită, 100 mg TRAMAL RETARD 100 mg, comprimate cu eliberare prelungită, 100 mg Tramal retard 100 mg, tabletten met verlengde afgifte Tramal retard 100 mg, tabletten met verlengde afgifte Tramal retard 100 mg, tabletten met verlengde afgifte Tramal retard 100 mg Retardtabletten Tramal retard 100 mg Retardtabletten Tramal retard 100 mg Retardtabletten Tramal Retard 100, 100 mg, tabletki o przedluzonym uwalnianiu
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/001
5419486
GRÜNENTHAL S.A.
PT
DE/H/0108/001
12497
GRÜNENTHAL GMBH
FI
DE/H/0108/001
12497
GRÜNENTHAL GMBH
FI
DE/H/0108/001
12497
GRÜNENTHAL GMBH
FI
not available
263099
STADA ARZNEIMITTEL AG
EE
not available
7021/2006/01
STADA ARZNEIMITTEL AG
RO
not available
7021/2006/02
STADA ARZNEIMITTEL AG
RO
DE/H/0108/001
RVG 22361
GRÜNENTHAL B.V.
NL
DE/H/0108/001
RVG 22361
GRÜNENTHAL B.V.
NL
DE/H/0108/001
RVG 22361
GRÜNENTHAL B.V.
NL
DE/H/0108/001
37297.00.00
GRÜNENTHAL GMBH
DE
DE/H/0108/001
37297.00.00
GRÜNENTHAL GMBH
DE
DE/H/0108/001
37297.00.00
GRÜNENTHAL GMBH
DE
not available
7862
STADA ARZNEIMITTEL AG
PL
List of nationally authorised medicinal products EMA/140794/2018
Page 189/220
Product Name (in authorisation country) Tramal retard 150 mg comprimidos de libertação prolongada Tramal retard 150 mg comprimidos de libertação prolongada Tramal retard 150 mg comprimidos de libertação prolongada Tramal retard 150 mg comprimidos de libertação prolongada Tramal retard 150 mg comprimidos de libertação prolongada Tramal retard 150 mg comprimidos de libertação prolongada Tramal retard 150 mg comprimidos de libertação prolongada Tramal retard 150 mg comprimidos de libertação prolongada Tramal retard 150 mg comprimidos de libertação prolongada Tramal retard 150 mg depottabletti Tramal retard 150 mg depottabletti Tramal retard 150 mg depottabletti TRAMAL RETARD 150 mg toimeainet prolongeeritult vabastavad tabletid
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/002
5419585
GRÜNENTHAL S.A.
PT
DE/H/0108/002
2972081
GRÜNENTHAL S.A.
PT
DE/H/0108/002
2511285
GRÜNENTHAL S.A.
PT
DE/H/0108/002
5419585
GRÜNENTHAL S.A.
PT
DE/H/0108/002
2972081
GRÜNENTHAL S.A.
PT
DE/H/0108/002
2511285
GRÜNENTHAL S.A.
PT
DE/H/0108/002
5419585
GRÜNENTHAL S.A.
PT
DE/H/0108/002
2972081
GRÜNENTHAL S.A.
PT
DE/H/0108/002
2511285
GRÜNENTHAL S.A.
PT
DE/H/0108/002
12498
GRÜNENTHAL GMBH
FI
DE/H/0108/002
12498
GRÜNENTHAL GMBH
FI
DE/H/0108/002
12498
GRÜNENTHAL GMBH
FI
not available
263199
STADA ARZNEIMITTEL AG
EE
List of nationally authorised medicinal products EMA/140794/2018
Page 190/220
Product Name (in authorisation country) TRAMAL RETARD 150 mg, comprimate cu eliberare prelungită, 150 mg TRAMAL RETARD 150 mg, comprimate cu eliberare prelungită, 150 mg Tramal retard 150 mg, tabletten met verlengde afgifte Tramal retard 150 mg, tabletten met verlengde afgifte Tramal retard 150 mg, tabletten met verlengde afgifte Tramal retard 150 mg Retardtabletten Tramal retard 150 mg Retardtabletten Tramal retard 150 mg Retardtabletten Tramal Retard 150, 150 mg, tabletki o przedłużonym uwalnianiu Tramal retard 200 mg comprimidos de libertação prolongada Tramal retard 200 mg comprimidos de libertação prolongada Tramal retard 200 mg comprimidos de libertação prolongada Tramal retard 200 mg comprimidos de libertação prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
6394/2006/02
STADA ARZNEIMITTEL AG
RO
not available
6394/2006/01
STADA ARZNEIMITTEL AG
RO
DE/H/0108/002
RVG 22362
GRÜNENTHAL B.V.
NL
DE/H/0108/002
RVG 22362
GRÜNENTHAL B.V.
NL
DE/H/0108/002
RVG 22362
GRÜNENTHAL B.V.
NL
DE/H/0108/002
37297.01.00
GRÜNENTHAL GMBH
DE
DE/H/0108/002
37297.01.00
GRÜNENTHAL GMBH
DE
DE/H/0108/002
37297.01.00
GRÜNENTHAL GMBH
DE
not available
7863
STADA ARZNEIMITTEL AG
PL
DE/H/0108/003
5419684
GRÜNENTHAL S.A.
PT
DE/H/0108/003
2972180
GRÜNENTHAL S.A.
PT
DE/H/0108/003
2511384
GRÜNENTHAL S.A.
PT
DE/H/0108/003
5419684
GRÜNENTHAL S.A.
PT
List of nationally authorised medicinal products EMA/140794/2018
Page 191/220
Product Name (in authorisation country) Tramal retard 200 mg comprimidos de libertação prolongada Tramal retard 200 mg comprimidos de libertação prolongada Tramal retard 200 mg comprimidos de libertação prolongada Tramal retard 200 mg comprimidos de libertação prolongada Tramal retard 200 mg comprimidos de libertação prolongada Tramal retard 200 mg depottabletti Tramal retard 200 mg depottabletti Tramal retard 200 mg depottabletti TRAMAL RETARD 200 mg toimeainet prolongeeritult vabastavad tabletid TRAMAL RETARD 200 mg, comprimate cu eliberare prelungită, 200 mg TRAMAL RETARD 200 mg, comprimate cu eliberare prelungită, 200 mg Tramal retard 200 mg, tabletten met verlengde afgifte Tramal retard 200 mg, tabletten met verlengde afgifte
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/003
2972180
GRÜNENTHAL S.A.
PT
DE/H/0108/003
2511384
GRÜNENTHAL S.A.
PT
DE/H/0108/003
5419684
GRÜNENTHAL S.A.
PT
DE/H/0108/003
2972180
GRÜNENTHAL S.A.
PT
DE/H/0108/003
2511384
GRÜNENTHAL S.A.
PT
DE/H/0108/003
12499
GRÜNENTHAL GMBH
FI
DE/H/0108/003
12499
GRÜNENTHAL GMBH
FI
DE/H/0108/003
12499
GRÜNENTHAL GMBH
FI
not available
263299
STADA ARZNEIMITTEL AG
EE
not available
6395/2006/02
STADA ARZNEIMITTEL AG
RO
not available
6395/2006/01
STADA ARZNEIMITTEL AG
RO
DE/H/0108/003
RVG 22363
GRÜNENTHAL B.V.
NL
DE/H/0108/003
RVG 22363
GRÜNENTHAL B.V.
NL
List of nationally authorised medicinal products EMA/140794/2018
Page 192/220
Product Name (in authorisation country) Tramal retard 200 mg, tabletten met verlengde afgifte Tramal retard 200 mg, Retardtabletten Tramal retard 200 mg, Retardtabletten Tramal retard 200 mg, Retardtabletten Tramal Retard 200, 200 mg, tabletki o przedłużonym uwalnianiu Tramal retard 50 mg depottabletti Tramal retard 50 mg depottabletti Tramal retard 50 mg depottabletti Tramal retard 50 mg Retardtabletten Tramal retard 50 mg Retardtabletten Tramal retard 50 mg Retardtabletten Tramal Retard 50, 50 mg, tabletki o przedluzonym uwalnianiu Tramal Retard 50, 50 mg, tabletki o przedluzonym uwalnianiu Tramal Retard 50, 50 mg, tabletki o przedluzonym uwalnianiu Tramal Retard 50, 50 mg, tabletki o przedluzonym uwalnianiu
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DE/H/0108/003
RVG 22363
GRÜNENTHAL B.V.
NL
DE/H/0108/003
37297.02.00
GRÜNENTHAL GMBH
DE
DE/H/0108/003
37297.02.00
GRÜNENTHAL GMBH
DE
DE/H/0108/003
37297.02.00
GRÜNENTHAL GMBH
DE
not available
7864
STADA ARZNEIMITTEL AG
PL
DE/H/0108/004
22364
GRÜNENTHAL GMBH
FI
DE/H/0108/004
22364
GRÜNENTHAL GMBH
FI
DE/H/0108/004
22364
GRÜNENTHAL GMBH
FI
DE/H/0108/004
60442.00.00
GRÜNENTHAL GMBH
DE
DE/H/0108/004
60442.00.00
GRÜNENTHAL GMBH
DE
DE/H/0108/004
60442.00.00
GRÜNENTHAL GMBH
DE
DE/H/0108/004
16764
STADA ARZNEIMITTEL AG
PL
DE/H/0108/004
16764
STADA ARZNEIMITTEL AG
PL
DE/H/0108/004
16764
STADA ARZNEIMITTEL AG
PL
DE/H/0108/004
16764
STADA ARZNEIMITTEL AG
PL
List of nationally authorised medicinal products EMA/140794/2018
Page 193/220
Product Name (in authorisation country) TRAMAL retard tablety 100 mg TRAMAL RETARD TABLETY 100 mg tablety s prodlouženým uvolňováním TRAMAL retard tablety 150 mg TRAMAL RETARD TABLETY 150 mg tablety s prodlouženým uvolňováním TRAMAL retard tablety 200 mg TRAMAL RETARD TABLETY 200 mg tablety s prodlouženým uvolňováním Tramal Tabletten, 50 mg TRAMAL tobolky 50 mg Tvrdé tobolky Tramal Tropfen, 100 mg/ml, Lösung zum Einnehmen Tramal Zäpfchen, 100 mg Tramal Zäpfchen, 100 mg TRAMAL, 100 mg rektaalsuposiidid Tramal, 100 mg, czopki Tramal, 100 mg/ml, krople doustne, roztwór TRAMAL, 50 mg kõvakapslid Tramal, 50 mg, kapsułki, twarde Tramal, 50 mg/1 ml, roztwór do wstrzykiwań Tramal, capsules, hard 50 mg
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
65/0359/97-S
STADA ARZNEIMITTEL AG
SK
not available
65/873/97-C
STADA ARZNEIMITTEL AG
CZ
not available
65/0359/97-S
STADA ARZNEIMITTEL AG
SK
not available
65/539/99-C
STADA ARZNEIMITTEL AG
CZ
not available
65/0359/97-S
STADA ARZNEIMITTEL AG
SK
not available
65/540/99-C
STADA ARZNEIMITTEL AG
CZ
not available not available
28705.00.00 65/075/91-S/C
GRÜNENTHAL GMBH STADA ARZNEIMITTEL AG
DE CZ
not available
120/88/06/0248
GRÜNENTHAL GMBH
LU
not available not available not available
13143.00.00 120/95/12/0414 142096
GRÜNENTHAL GMBH GRÜNENTHAL GMBH STADA ARZNEIMITTEL AG
DE LU EE
not available not available
2537 2539
STADA ARZNEIMITTEL AG STADA ARZNEIMITTEL AG
PL PL
not available not available
141996 2536
STADA ARZNEIMITTEL AG STADA ARZNEIMITTEL AG
EE PL
not available
2538
STADA ARZNEIMITTEL AG
PL
not available
RVG 15511
GRÜNENTHAL B.V.
NL
List of nationally authorised medicinal products EMA/140794/2018
Page 194/220
Product Name (in authorisation country) Tramal, druppels voor oraal gebruik, oplossing 100 mg/ml Tramal® 100 mg Ampullen Tramal® 100 mg filmsko obložene tablete s podaljšanim sprošcanjem Tramal® 150 mg filmsko obložene tablete s podaljšanim sproščanjem Tramal® 200 mg filmsko obložene tablete s podaljšanim sproščanjem Tramal® 50 mg Ampullen Tramal® 50 mg Kapseln Tramal® retard 100 mg Filmtabletten Tramal® retard 150 mg Filmtabletten Tramal® retard 200 mg Filmtabletten Tramal® Tropfen Tramalgic 50 mg kemény kapszula Tramalgic 50 mg kemény kapszula Tramalgic 50 mg kemény kapszula Tramalgin, 50 mg/mL, roztwór do wstrzykiwań TRAMALIN 100 mg compresse a rilascio prolungato TRAMALIN 100 mg compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
RVG 15513
GRÜNENTHAL B.V.
NL
not available not available
17.690 H/92/01556/001
GRÜNENTHAL GES. M.B.H. STADA ARZNEIMITTEL AG
AT SI
not available
H/92/01556/002
STADA ARZNEIMITTEL AG
SI
not available
H/92/01556/003
STADA ARZNEIMITTEL AG
SI
not available not available not available
17692 17.688 1-21219
GRÜNENTHAL GES. M.B.H. GRÜNENTHAL GES. M.B.H. GRÜNENTHAL GES. M.B.H.
AT AT AT
not available
1-21218
GRÜNENTHAL GES. M.B.H.
AT
not available
1-21217
GRÜNENTHAL GES. M.B.H.
AT
not available not available
17.689 OGYI-T-6565/01
GRÜNENTHAL GES. M.B.H. TAKEDA PHARMA KFT.
AT HU
not available
OGYI-T-6565/02
TAKEDA PHARMA KFT.
HU
not available
OGYI-T-6565/03
TAKEDA PHARMA KFT.
HU
not available
21762
PL
AT/H/0118/001
035846017
SOPHARMA WARSZAWA SP. Z O.O. S.F. GROUP SRL
AT/H/0118/001
035846029
S.F. GROUP SRL
IT
List of nationally authorised medicinal products EMA/140794/2018
IT
Page 195/220
Product Name (in authorisation country) TRAMALIN 100 mg compresse a rilascio prolungato TRAMALIN 100 mg compresse a rilascio prolungato TRAMALIN 100 mg compresse a rilascio prolungato TRAMALIN 100 mg compresse a rilascio prolungato TRAMALIN 100 mg compresse a rilascio prolungato TRAMALIN 100 mg compresse a rilascio prolungato TRAMALIN 150 mg compresse a rilascio prolungato TRAMALIN 150 mg compresse a rilascio prolungato TRAMALIN 150 mg compresse a rilascio prolungato TRAMALIN 150 mg compresse a rilascio prolungato TRAMALIN 150 mg compresse a rilascio prolungato TRAMALIN 150 mg compresse a rilascio prolungato
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
AT/H/0118/001
035846031
S.F. GROUP SRL
IT
AT/H/0118/001
035846043
S.F. GROUP SRL
IT
AT/H/0118/001
035846056
S.F. GROUP SRL
IT
AT/H/0118/001
035846068
S.F. GROUP SRL
IT
AT/H/0118/001
035846070
S.F. GROUP SRL
IT
AT/H/0118/001
035846082
S.F. GROUP SRL
IT
AT/H/0118/002
035846094
S.F. GROUP SRL
IT
AT/H/0118/002
035846106
S.F. GROUP SRL
IT
AT/H/0118/002
035846118
S.F. GROUP SRL
IT
AT/H/0118/002
035846120
S.F. GROUP SRL
IT
AT/H/0118/002
035846132
S.F. GROUP SRL
IT
AT/H/0118/002
035846144
S.F. GROUP SRL
IT
List of nationally authorised medicinal products EMA/140794/2018
Page 196/220
Product Name (in authorisation country) TRAMALIN 150 mg compresse a rilascio prolungato TRAMALIN 150 mg compresse a rilascio prolungato TRAMALIN 200 mg compresse a rilascio prolungato TRAMALIN 200 mg compresse a rilascio prolungato TRAMALIN 200 mg compresse a rilascio prolungato TRAMALIN 200 mg compresse a rilascio prolungato TRAMALIN 200 mg compresse a rilascio prolungato TRAMALIN 200 mg compresse a rilascio prolungato TRAMALIN 200 mg compresse a rilascio prolungato TRAMALIN 200 mg compresse a rilascio prolungato Tramamed 100 mg Retardtabletten Tramamed 150 mg Retardtabletten Tramamed 200 mg Retardtabletten
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
AT/H/0118/002
035846157
S.F. GROUP SRL
IT
AT/H/0118/002
035846169
S.F. GROUP SRL
IT
AT/H/0118/003
035846171
S.F. GROUP SRL
IT
AT/H/0118/003
035846183
S.F. GROUP SRL
IT
AT/H/0118/003
035846195
S.F. GROUP SRL
IT
AT/H/0118/003
035846207
S.F. GROUP SRL
IT
AT/H/0118/003
035846219
S.F. GROUP SRL
IT
AT/H/0118/003
035846245
S.F. GROUP SRL
IT
AT/H/0118/003
035846221
S.F. GROUP SRL
IT
AT/H/0118/003
035846233
S.F. GROUP SRL
IT
DE/H/0288/001
44607.00.00
HEXAL AG
DE
DE/H/0288/002
44607.01.00
HEXAL AG
DE
DE/H/0288/003
44607.02.00
HEXAL AG
DE
List of nationally authorised medicinal products EMA/140794/2018
Page 197/220
Product Name (in authorisation country) Tramapine 50 mg Capsules
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
PA0281/100/1
IE
Tramapine 50 mg Capsules
not available
PA0281/100/1
Tramastad Ampullen Tramastad Ampullen Tramastad Tropfen Tramastad Tropfen Tramastad
100 mg/2 ml
not available
1-23281
100 mg/2 ml
not available
1-23281
100 mg/ml
not available
1-23282
100 mg/ml
not available
1-23282
50 mg Kapseln
not available
1-23280
Tramastad 50 mg Kapseln
not available
1-23280
TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible
UK/H/0641/001
366 516 366 517 366 518 366 520 566 006 566 007 566 008 566 009 566 010 366 516
OU 34009 366
PINEWOOD LABORATORIES LIMITED PINEWOOD LABORATORIES LIMITED STADA ARZNEIMITTEL GMBH STADA ARZNEIMITTEL GMBH STADA ARZNEIMITTEL GMBH STADA ARZNEIMITTEL GMBH STADA ARZNEIMITTEL GMBH STADA ARZNEIMITTEL GMBH ETHYPHARM
OU 34009 366
ETHYPHARM
FR
OU 34009 366
ETHYPHARM
FR
OU 34009 366
ETHYPHARM
FR
OU 34009 566
ETHYPHARM
FR
OU 34009 566
ETHYPHARM
FR
OU 34009 566
ETHYPHARM
FR
OU 34009 566
ETHYPHARM
FR
OU 34009 566
ETHYPHARM
FR
OU 34009 366
ETHYPHARM
FR
UK/H/0641/001 UK/H/0641/001 UK/H/0641/001 UK/H/0641/001 UK/H/0641/001 UK/H/0641/001 UK/H/0641/001 UK/H/0641/001 UK/H/0641/001
List of nationally authorised medicinal products EMA/140794/2018
516-0 09 517-7 77 518-3 38 520-8 88 006-6 63 007-2 24 008-9 92 009-5 53 010-3 35 516-0 09
IE AT AT AT AT AT AT FR
Page 198/220
Product Name (in authorisation country) TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible TRAMELENE 50 mg, comprimé orodispersible TRAMELENE FLASHTAB 50 mg orodispersible tablet TRAMELENE FLASHTAB 50 mg orodispersible tablet Tramium 100 mg ,Hartkapseln , retardiert Tramium 100 mg ,Hartkapseln , retardiert TRAMIUM 100 mg capsules met verlengde afgifte, hard TRAMIUM 100 mg depotkapseli, kova TRAMIUM 100 mg Gélule à libération prolongée TRAMIUM 100 mg Gélule à libération prolongée Tramium 150 mg ,Hartkapseln , retardiert TRAMIUM 150 mg capsules met verlengde afgifte, hard
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0641/001
366
ETHYPHARM
FR
366
ETHYPHARM
FR
366
ETHYPHARM
FR
566
ETHYPHARM
FR
566
ETHYPHARM
FR
566
ETHYPHARM
FR
566
ETHYPHARM
FR
566
ETHYPHARM
FR
UK/H/0641/001
366 517-7 OU 34009 517 7 7 366 518-3 OU 34009 518 3 8 366 520-8 OU 34009 520 8 8 566 006-6 OU 34009 006 6 3 566 007-2 OU 34009 007 2 4 566 008-9 OU 34009 008 9 2 566 009-5 OU 34009 009 5 3 566 010-3 OU 34009 010 3 5 PL 06934/0071
ETHYPHARM
UK
UK/H/0641/001
PL 06934/0071
ETHYPHARM
UK
FI/H/0164/001
BE249103
LABORATOIRES SMB S.A.
BE
FI/H/0164/001
2003070040
LABORATOIRES SMB S.A.
LU
FI/H/0164/001
BE249103
LABORATOIRES SMB S.A.
BE
FI/H/0164/001
16710
LABORATOIRES SMB S.A.
FI
FI/H/0164/001
BE249103
LABORATOIRES SMB S.A.
BE
FI/H/0164/001
2003070040
LABORATOIRES SMB S.A.
LU
FI/H/0164/002
2003070039
LABORATOIRES SMB S.A.
LU
FI/H/0164/002
BE249112
LABORATOIRES SMB S.A.
BE
UK/H/0641/001 UK/H/0641/001 UK/H/0641/001 UK/H/0641/001 UK/H/0641/001 UK/H/0641/001 UK/H/0641/001
List of nationally authorised medicinal products EMA/140794/2018
Page 199/220
Product Name (in authorisation country) TRAMIUM 150 mg depotkapseli, kova TRAMIUM 150 mg Gélule à libération prolongée TRAMIUM 150 mg Gélule à libération prolongée Tramium 150 mg, Hartkapseln, retardiert Tramium 200 mg ,Hartkapseln , retardiert TRAMIUM 200 mg capsules met verlengde afgifte, hard TRAMIUM 200 mg depotkapseli, kova TRAMIUM 200 mg Gélule à libération prolongée TRAMIUM 200 mg Gélule à libération prolongée Tramium 200 mg, Hartkapseln, retardiert Tramól-L 100 mg forðatöflur Tramól-L 150 mg forðatöflur Tramól-L 200 mg forðatöflur Tramquel SR 100 mg prolonged-release hard capsules Tramquel SR 150 mg prolonged-release hard capsules Tramquel SR 200 mg prolonged-release hard capsules Tramquel SR 50 mg prolonged-release hard capsules
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FI/H/0164/002
16711
LABORATOIRES SMB S.A.
FI
FI/H/0164/002
BE249112
LABORATOIRES SMB S.A.
BE
FI/H/0164/002
2003070039
LABORATOIRES SMB S.A.
LU
FI/H/0164/002
BE249112
LABORATOIRES SMB S.A.
BE
FI/H/0164/003
2003070041
LABORATOIRES SMB S.A.
LU
FI/H/0164/003
BE249121
LABORATOIRES SMB S.A.
BE
FI/H/0164/003
16712
LABORATOIRES SMB S.A.
FI
FI/H/0164/003
BE249121
LABORATOIRES SMB S.A.
BE
FI/H/0164/003
2003070041
LABORATOIRES SMB S.A.
LU
FI/H/0164/003
BE249121
LABORATOIRES SMB S.A.
BE
AT/H/0117/001 AT/H/0117/002 AT/H/0117/003 UK/H/0301/002
IS/1/01/037/01 IS/1/01/037/02 IS/1/01/037/03 PL 15142/0125
ACTAVIS HF. ACTAVIS HF. ACTAVIS HF. BEECHMERE PHARMACEUTICALS LTD
IS IS IS UK
UK/H/0301/003
PL 15142/0126
BEECHMERE PHARMACEUTICALS LTD
UK
UK/H/0301/004
PL 15142/0127
BEECHMERE PHARMACEUTICALS LTD
UK
UK/H/0301/001
PL 15142/0124
BEECHMERE PHARMACEUTICALS LTD
UK
List of nationally authorised medicinal products EMA/140794/2018
Page 200/220
Product Name (in authorisation country) Tramulief SR 100 mg prolonged-release tablets Tramulief SR 150 mg prolonged-release tablets Tramulief SR 200 mg prolonged-release tablets Tramundal 50 mg Filmtabletten Tramundal retard 100 mg Filmtabletten Tramundal retard 150 mg Filmtabletten Tramundal retard 200 mg Filmtabletten Tramundal Tropfen Tramundin 100 mg tablete s podaljšanim sproščanjem Tramundin retard 100 mg Retardtabletten Tramundin retard 100 mg tablete s produljenim oslobađanjem Tramundin Retard 100mg tablety s prodlouženým uvolňováním Tramundin retard 150 mg Retardtabletten Tramundin retard 200 mg Retardtabletten Tramundin, 100 mg, tabletki powlekane o przedluZonym uwalnianiu Tramundin® 50 mg Filmtabletten
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
NL/H/0889/001
PL 20072/0235
AMDIPHARM UK LIMITED
UK
NL/H/0889/002
PL 20072/0236
AMDIPHARM UK LIMITED
UK
NL/H/0889/003
PL 20072/0237
AMDIPHARM UK LIMITED
UK
not available
1-21777
MUNDIPHARMA GES.M.B.H
AT
not available
1-22187
MUNDIPHARMA GES.M.B.H
AT
AT/H/0120/001
1-22188
MUNDIPHARMA GES.M.B.H
AT
AT/H/0120/002
1-22189
MUNDIPHARMA GES.M.B.H
AT
not available not available
1-22186 H/00/01557/001
MUNDIPHARMA GES.M.B.H MEDIS, D.O.O.
AT SI
not available
34105.00.00
MUNDIPHARMA GMBH
DE
not available
UP/I-530-09/12-02/14
MEDIS ADRIA D.O.O.
HR
not available
65/540/00-C
MUNDIPHARMA GES.M.B.H
CZ
AT/H/0120/001
34105.01.00
MUNDIPHARMA GMBH
DE
AT/H/0120/002
34105.02.00
MUNDIPHARMA GMBH
DE
not available
9474
NORPHARMA A/S
PL
not available
6391213.00.00
MUNDIPHARMA GMBH
DE
List of nationally authorised medicinal products EMA/140794/2018
Page 201/220
Product Name (in authorisation country) TRAM-U-RON OD 100 mg ｡psulas de liberta ﾃｧﾃ｣o prolongada TRAM-U-RON OD 100 mg ｡psulas de liberta ﾃｧﾃ｣o prolongada TRAM-U-RON OD 100 mg ｡psulas de liberta ﾃｧﾃ｣o prolongada TRAM-U-RON OD 100 mg ｡psulas de liberta ﾃｧﾃ｣o prolongada TRAM-U-RON OD 150 mg ｡psulas de liberta ﾃｧﾃ｣o prolongada TRAM-U-RON OD 150 mg ｡psulas de liberta ﾃｧﾃ｣o prolongada TRAM-U-RON OD 150 mg ｡psulas de liberta ﾃｧﾃ｣o prolongada TRAM-U-RON OD 150 mg ｡psulas de liberta ﾃｧﾃ｣o prolongada TRAM-U-RON OD 200 mg ｡psulas de liberta ﾃｧﾃ｣o prolongada TRAM-U-RON OD 200 mg ｡psulas de liberta ﾃｧﾃ｣o prolongada TRAM-U-RON OD 200 mg ｡psulas de liberta ﾃｧﾃ｣o prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
cﾃ
FI/H/0164/001
4392882
BENE FARMACÊUTICA, LDA.
PT
cﾃ
FI/H/0164/001
4392981
BENE FARMACÊUTICA, LDA.
PT
cﾃ
FI/H/0164/001
4393088
BENE FARMACÊUTICA, LDA.
PT
cﾃ
FI/H/0164/001
4393187
BENE FARMACÊUTICA, LDA.
PT
cﾃ
FI/H/0164/002
4393286
BENE FARMACÊUTICA, LDA.
PT
cﾃ
FI/H/0164/002
4393385
BENE FARMACÊUTICA, LDA.
PT
cﾃ
FI/H/0164/002
4393484
BENE FARMACÊUTICA, LDA.
PT
cﾃ
FI/H/0164/002
4393583
BENE FARMACÊUTICA, LDA.
PT
cﾃ
FI/H/0164/003
4393682
BENE FARMACÊUTICA, LDA.
PT
cﾃ
FI/H/0164/003
4393781
BENE FARMACÊUTICA, LDA.
PT
cﾃ
FI/H/0164/003
4393880
BENE FARMACÊUTICA, LDA.
PT
List of nationally authorised medicinal products EMA/140794/2018
Page 202/220
Product Name (in authorisation country) TRAM-U-RON OD 200 mg C ﾃ｡psulas de liberta ﾃｧﾃ｣o prolongada TRAVEX DIREKT 50 mg
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FI/H/0164/003
4393989
BENE FARMACÊUTICA, LDA.
PT
UK/H/0640/001
42429.00.01
DE
TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada
UK/H/0306/001
3381688
MEDA PHARMA GMBH & CO. KG MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
UK/H/0306/001
3381787
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3381886
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3382082
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3381985
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3768587
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3382181
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3382280
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3382389
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3382488
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
List of nationally authorised medicinal products EMA/140794/2018
PT
Page 203/220
Product Name (in authorisation country) TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0306/001
3382587
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3382686
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3382785
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3382884
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3382983
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3383189
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3383080
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3827086
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3383288
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3383387
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3383486
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3383585
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
List of nationally authorised medicinal products EMA/140794/2018
Page 204/220
Product Name (in authorisation country) TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 150 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0306/001
3383783
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
3383882
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3383981
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3384088
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3384187
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3384286
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3384385
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3768686
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3384484
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3678182
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3384682
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3384880
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
List of nationally authorised medicinal products EMA/140794/2018
Page 205/220
Product Name (in authorisation country) TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0306/002
3384781
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3384989
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3385085
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3385184
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3385283
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3385481
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3385382
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3827185
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3385689
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3385580
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3385887
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3385986
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
List of nationally authorised medicinal products EMA/140794/2018
Page 206/220
Product Name (in authorisation country) TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 200 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0306/002
3385788
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/002
3386083
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3386281
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3386182
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3386984
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3387081
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3386687
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3386786
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3386588
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3387289
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3387180
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3386885
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
List of nationally authorised medicinal products EMA/140794/2018
Page 207/220
Product Name (in authorisation country) TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0306/003
3386489
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3768785
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3386380
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3387487
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3388287
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3387586
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3387685
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3387388
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3387784
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3827284
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3387883
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3387982
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
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Page 208/220
Product Name (in authorisation country) TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 300 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0306/003
3388089
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/003
3388188
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3388485
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3388683
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3388386
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3388584
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3388782
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3388881
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3388980
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3768884
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3389285
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3389483
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
List of nationally authorised medicinal products EMA/140794/2018
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Product Name (in authorisation country) TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0306/004
3389384
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3389582
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3389681
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3389780
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3390085
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3827383
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3389988
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3389889
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3390184
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3390283
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3390382
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3390481
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
List of nationally authorised medicinal products EMA/140794/2018
Page 210/220
Product Name (in authorisation country) TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada TRAVEX Long 400 mg Comprimido de liberta ﾃｧﾃ｣o prolongada Travex Rapid 50 mg comprimidos Orodispersíveis Travex retard 100 mg Hartkapseln, retardiert Travex retard 150 mg Hartkapseln, retardiert Travex retard 200 mg Hartkapseln, retardiert Travex retard 50 mg Hartkapseln, retardiert TRAVEX® 100 mg Cápsula dura de libertação prolongada TRAVEX® 100 mg Cápsula dura de libertação prolongada TRAVEX® 100 mg Cápsula dura de libertação prolongada TRAVEX® 100 mg Cápsula dura de libertação prolongada TRAVEX® 100 mg Cápsula dura de libertação prolongada TRAVEX® 100 mg Cápsula dura de libertação prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0306/004
3389087
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/004
3389186
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0640/001
5264288
PT
UK/H/0225/002
42429.01.00
UK/H/0225/003
42429.02.00
UK/H/0225/004
42429.03.00
UK/H/0225/001
42429.00.00
UK/H/0225/002
2632784
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A. MEDA PHARMA GMBH & CO. KG MEDA PHARMA GMBH & CO. KG MEDA PHARMA GMBH & CO. KG MEDA PHARMA GMBH & CO. KG MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
UK/H/0225/002
4376588
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/002
4376687
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/002
4376786
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/002
4376885
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/002
4376984
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
List of nationally authorised medicinal products EMA/140794/2018
DE DE DE DE PT
Page 211/220
Product Name (in authorisation country) TRAVEX® 150 mg Cápsula dura de libertação prolongada TRAVEX® 150 mg Cápsula dura de libertação prolongada TRAVEX® 150 mg Cápsula dura de libertação prolongada TRAVEX® 150 mg Cápsula dura de libertação prolongada TRAVEX® 150 mg Cápsula dura de libertação prolongada TRAVEX® 150 mg Cápsula dura de libertação prolongada TRAVEX® 200 mg Cápsula dura de libertação prolongada TRAVEX® 200 mg Cápsula dura de libertação prolongada TRAVEX® 200 mg Cápsula dura de libertação prolongada TRAVEX® 200 mg Cápsula dura de libertação prolongada TRAVEX® 200 mg Cápsula dura de libertação prolongada TRAVEX® 200 mg Cápsula dura de libertação prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0225/003
2632883
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/003
4377180
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/003
4377081
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/003
4377289
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/003
4377388
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/003
4377487
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/004
4377586
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/004
2632982
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/004
4377685
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/004
4377784
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/004
4377883
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/004
4377982
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
List of nationally authorised medicinal products EMA/140794/2018
Page 212/220
Product Name (in authorisation country) TRAVEX® 50 mg Cápsula dura de libertação prolongada TRAVEX® 50 mg Cápsula dura de libertação prolongada TRAVEX® 50 mg Cápsula dura de libertação prolongada TRAVEX® 50 mg Cápsula dura de libertação prolongada TRAVEX® 50 mg Cápsula dura de libertação prolongada TRAVEX® 50 mg Cápsula dura de libertação prolongada TRAVEX® ONE 150 mg Retardtabletten TRAVEX® ONE 200 mg Retardtabletten TRAVEX® ONE 300 mg Retardtabletten TRAVEX® ONE 400 mg Retardtabletten Tridural 100 mg prolongedrelease tablets
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0225/001
4376083
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/001
2632685
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/001
4376182
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/001
4376281
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/001
4376489
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0225/001
4376380
MEDA PHARMA – PRODUTOS FARMACÊUTICOS, S.A.
PT
UK/H/0306/001
46414.00.00
DE
UK/H/0306/002
46414.01.00
UK/H/0306/003
46414.02.00
UK/H/0306/004
46414.03.00
FR/H/272/01
5715081
Tridural 200 mg prolongedrelease tablets
FR/H/272/02
5715180
MEDA PHARMA GMBH & CO. KG MEDA PHARMA GMBH & CO. KG MEDA PHARMA GMBH & CO. KG MEDA PHARMA GMBH & CO. KG KIRONFARMA, PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA. KIRONFARMA, PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA.
List of nationally authorised medicinal products EMA/140794/2018
DE DE DE PT
PT
Page 213/220
Product Name (in authorisation country) Tridural 300 mg prolongedrelease tablets
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FR/H/272/03
5715289
PT
Tropium 100mg/2ml ενέσιμο διάλυμα TRΑΜΑL® καψάκιο σκληρό 50 mg TRΑΜΑL® πόσιμες σταγόνες, διάλυμα 100 mg/ml UNITRAMA 100 MG COMPRESSE A RILASCIO PROLUNGATO UNITRAMA 100 MG COMPRESSE A RILASCIO PROLUNGATO UNITRAMA 100 MG COMPRESSE A RILASCIO PROLUNGATO UNITRAMA 100 MG COMPRESSE A RILASCIO PROLUNGATO UNITRAMA 100 MG COMPRESSE A RILASCIO PROLUNGATO UNITRAMA 100 MG COMPRESSE A RILASCIO PROLUNGATO UNITRAMA 100 MG COMPRESSE A RILASCIO PROLUNGATO UNITRAMA 100 MG COMPRESSE A RILASCIO PROLUNGATO UNITRAMA 100 MG COMPRESSE A RILASCIO PROLUNGATO
not available
34672/24-05-12
KIRONFARMA, PRODUTOS FARMACÊUTICOS, SOCIEDADE UNIPESSOAL, LDA. MEDOCHEMIE HELLAS SA
not available
97924
VIANEX S.A.
GR
not available
30122
VIANEX S.A.
GR
FR/H/0272/001
037003074/M
ENDO VENTURES LIMITED
IT
FR/H/0272/001
037003086/M
ENDO VENTURES LIMITED
IT
FR/H/0272/001
037003098/M
ENDO VENTURES LIMITED
IT
FR/H/0272/001
037003047/M
ENDO VENTURES LIMITED
IT
FR/H/0272/001
037003100/M
ENDO VENTURES LIMITED
IT
FR/H/0272/001
037003353/M
ENDO VENTURES LIMITED
IT
FR/H/0272/001
037003050/M
ENDO VENTURES LIMITED
IT
FR/H/0272/001
037003112/M
ENDO VENTURES LIMITED
IT
FR/H/0272/001
037003062/M
ENDO VENTURES LIMITED
IT
List of nationally authorised medicinal products EMA/140794/2018
GR
Page 214/220
Product Name (in authorisation country) UNITRAMA 100 MG COMPRESSE A RILASCIO PROLUNGATO UNITRAMA 100 MG COMPRESSE A RILASCIO PROLUNGATO UNITRAMA 100 MG COMPRESSE A RILASCIO PROLUNGATO UNITRAMA 100 MG COMPRESSE A RILASCIO PROLUNGATO UNITRAMA 100 MG COMPRESSE A RILASCIO PROLUNGATO UNITRAMA 100 MG COMPRESSE A RILASCIO PROLUNGATO UNITRAMA 200 MG UNITRAMA 200 MG UNITRAMA 200 MG UNITRAMA 200 MG UNITRAMA 200 MG UNITRAMA 200 MG UNITRAMA 200 MG UNITRAMA 200 MG UNITRAMA 200 MG UNITRAMA 200 MG UNITRAMA 200 MG UNITRAMA 200 MG UNITRAMA 200 MG UNITRAMA 200 MG UNITRAMA 200 MG UNITRAMA 300 MG UNITRAMA 300 MG UNITRAMA 300 MG
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FR/H/0272/001
037003124/M
ENDO VENTURES LIMITED
IT
FR/H/0272/001
037003252/M
ENDO VENTURES LIMITED
IT
FR/H/0272/001
037003011/M
ENDO VENTURES LIMITED
IT
FR/H/0272/001
037003023/M
ENDO VENTURES LIMITED
IT
FR/H/0272/001
037003035/M
ENDO VENTURES LIMITED
IT
FR/H/0272/001
037003340/M
ENDO VENTURES LIMITED
IT
FR/H/0272/002 FR/H/0272/002 FR/H/0272/002 FR/H/0272/002 FR/H/0272/002 FR/H/0272/002 FR/H/0272/002 FR/H/0272/002 FR/H/0272/002 FR/H/0272/002 FR/H/0272/002 FR/H/0272/002 FR/H/0272/002 FR/H/0272/002 FR/H/0272/002 FR/H/0272/003 FR/H/0272/003 FR/H/0272/003
037003136/M 037003199/M 037003148/M 37003201/M 037003151/M 037003213/M 037003365/M 037003163/M 037003225/M 037003377/M 037003175/M 037003237/M 037003187/M 037003249/M 037003264/M 037003290/M 037003302/M 037003314/M
ENDO ENDO ENDO ENDO ENDO ENDO ENDO ENDO ENDO ENDO ENDO ENDO ENDO ENDO ENDO ENDO ENDO ENDO
IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT IT
List of nationally authorised medicinal products EMA/140794/2018
VENTURES VENTURES VENTURES VENTURES VENTURES VENTURES VENTURES VENTURES VENTURES VENTURES VENTURES VENTURES VENTURES VENTURES VENTURES VENTURES VENTURES VENTURES
LIMITED LIMITED LIMITED LIMITED LIMITED LIMITED LIMITED LIMITED LIMITED LIMITED LIMITED LIMITED LIMITED LIMITED LIMITED LIMITED LIMITED LIMITED
Page 215/220
Product Name (in authorisation country) UNITRAMA 300 MG UNITRAMA 300 MG UNITRAMA 300 MG UNITRAMA 300 MG UNITRAMA 300 MG UNITRAMA 300 MG VIBRALIS 100mg καψάκιο παρατεταμένης αποδέσμευσης, σκληρό VIBRALIS 150 MG ΚΑΨΑΚΙΑ ΠΑΡΑΤΕΤΑΜΕΝΗΣ ΑΠΟΔΕΣΜΕΥΣΗΣ, ΣΚΛΗΡΑ VIBRALIS 200 mg ΚΑΨΑΚΙΑ ΠΑΡΑΤΕΤΑΜΕΝΗΣ ΑΠΟΔΕΣΜΕΥΣΗΣ, ΣΚΛΗΡΑ Xymel 50 mg Capsules Xymel SR 100 mg prolonged release tablets ZAMADOL 24hr 150mg prolonged release tablets ZAMADOL 24hr 200mg prolonged release tablets ZAMADOL 24hr 300mg prolonged release tablets ZAMADOL 24hr 400mg prolonged release tablets Zamadol Capsules 50 mg
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
FR/H/0272/003 FR/H/0272/003 FR/H/0272/003 FR/H/0272/003 FR/H/0272/003 FR/H/0272/003 not available
037003389/M 037003326/M 037003391/M 037003338/M 037003276/M 037003288/M 39659/13/12-12-2014
ENDO VENTURES LIMITED ENDO VENTURES LIMITED ENDO VENTURES LIMITED ENDO VENTURES LIMITED ENDO VENTURES LIMITED ENDO VENTURES LIMITED MEDITRINA PHARMACEUTICAL LIMITED
IT IT IT IT IT IT GR
not available
38360/29-5-2012
MEDITRINA PHARMACEUTICAL LIMITED
GR
not available
38361/29-5-2012
MEDITRINA PHARMACEUTICAL LIMITED
GR
not available not available
PA0126/099/001 PA 126/99/2
CLONMEL HEALTHCARE LTD. CLONMEL HEALTHCARE LTD.
IE IE
UK/H/0306/001
PL 16950/0084
UK
UK/H/0306/002
PL 16950/0085
UK/H/0306/003
PL 16950/0086
UK/H/0306/004
PL 16950/0087
not available
PL 15142/0119
Zamadol Melt 50 mg Tablets
not available
PL 15142/0128
Zamadol SR 100 mg prolonged-release hard capsules Zamadol SR 150 mg prolonged-release hard capsules
UK/H/0225/002
PL 15142/0121
NAPP PHARMACEUTICALS LTD NAPP PHARMACEUTICALS LTD NAPP PHARMACEUTICALS LTD NAPP PHARMACEUTICALS LTD MEDA PHARMACEUTICALS LTD MEDA PHARMACEUTICALS LTD MEDA PHARMACEUTICALS LTD
UK/H/0225/003
PL 15142/0122
MEDA PHARMACEUTICALS LTD
UK
List of nationally authorised medicinal products EMA/140794/2018
UK UK UK UK UK UK
Page 216/220
Product Name (in authorisation country) Zamadol SR 200 mg prolonged-release hard capsules Zamadol SR 50 mg prolonged-release hard capsules Zamadol® Injection
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0225/004
PL 15142/0123
MEDA PHARMACEUTICALS LTD
UK
UK/H/0225/001
PL 15142/0120
MEDA PHARMACEUTICALS LTD
UK
not available
PL 15142/0118
UK
ZAMUDOL LP 100 mg, gélule à libération prolongée ZAMUDOL LP 100 mg, gélule à libération prolongée ZAMUDOL LP 150 mg, gélule à libération prolongée ZAMUDOL LP 150 mg, gélule à libération prolongée ZAMUDOL LP 200 mg, gélule à libération prolongée ZAMUDOL LP 200 mg, gélule à libération prolongée ZAMUDOL LP 50 mg, gélule à libération prolongée ZAMUDOL LP 50 mg, gélule à libération prolongée Zeridame SR 100mg Prolonged Release Tablets Zeridame SR 150mg Prolonged Release Tablets Zeridame SR 200mg Prolonged Release Tablets ZYDOL 100 mg / 2 ml Solution for Injection ZYDOL 50 mg Hard Capsules ZYDOL 50mg Capsules ZYDOL 50mg Soluble Tablets
UK/H/0225/002
346 544.9
MEDA PHARMACEUTICALS LTD MEDA PHARMA SAS
UK/H/0225/002
346 543.2
MEDA PHARMA SAS
FR
UK/H/0225/003
346 546.1
MEDA PHARMA SAS
FR
UK/H/0225/003
346 545.5
MEDA PHARMA SAS
FR
UK/H/0225/004
346 548.4
MEDA PHARMA SAS
FR
UK/H/0225/004
346 547.8
MEDA PHARMA SAS
FR
UK/H/0225/001
346 542.6
MEDA PHARMA SAS
FR
UK/H/0225/001
346 540.3
MEDA PHARMA SAS
FR
NL/H/0890/001
PL 30306/0722
ACTAVIS GROUP PTC EHF.
UK
NL/H/0890/002
PL 30306/0723
ACTAVIS GROUP PTC EHF.
UK
NL/H/0890/003
PL 30306/0724
ACTAVIS GROUP PTC EHF.
UK
not available
PA 1189/1/4
GRÜNENTHAL LTD.
IE
not available not available not available
PA 1189/1/1 PL 21727/0001 PL 21727/0006
GRÜNENTHAL LTD. GRÜNENTHAL LTD. GRÜNENTHAL LTD.
IE UK UK
List of nationally authorised medicinal products EMA/140794/2018
FR
Page 217/220
Product Name (in authorisation country) ZYDOL SR 100 mg prolonged-release tablets ZYDOL SR 100 mg prolonged-release Tablets ZYDOL SR 150 mg prolonged-release tablets ZYDOL SR 150 mg prolonged-release tablets ZYDOL SR 200 mg prolonged-release tablets ZYDOL SR 200 mg prolonged-release tablets ZYDOL XL 150 mg prolonged release tablets ZYDOL XL 200 mg prolonged release tablets ZYDOL XL 300 mg prolonged release tablets ZYDOL XL 400 mg prolonged release tablets ZYDOL® 50 mg/ml Solution for Injection ZYTRAM ZYTRAM ZYTRAM ZYTRAM Zytram 150 mg comprimidos de liberación prolongada Zytram 200 mg comprimidos de liberación prolongada Zytram 300 mg comprimidos de liberación prolongada
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available
PA 1189/1/6
GRÜNENTHAL LTD.
IE
not available
PL 21727/0003
GRÜNENTHAL LTD.
UK
not available
PA 1189/1/7
GRÜNENTHAL LTD.
IE
not available
PL 21727/0004
GRÜNENTHAL LTD.
UK
not available
PA 1189/1/8
GRÜNENTHAL LTD.
IE
not available
PL 21727/0005
GRÜNENTHAL LTD.
UK
not available
PL 16950/0089
UK
not available
PL 16950/0090
not available
PL 16950/0091
not available
PL 16950/0092
not available
PL 21727/0002
NAPP PHARMACEUTICALS LTD NAPP PHARMACEUTICALS LTD NAPP PHARMACEUTICALS LTD NAPP PHARMACEUTICALS LTD GRÜNENTHAL LTD.
not available not available not available not available UK/H/0306/001
970500 970499 970501 970498 63.130
NORPHARMA A/S NORPHARMA A/S NORPHARMA A/S NORPHARMA A/S MUNDIPHARMA PHARMACEUTICALS SL
IS IS IS IS ES
UK/H/00306/002
63.131
MUNDIPHARMA PHARMACEUTICALS SL
ES
UK/H/0306/003
63.132
MUNDIPHARMA PHARMACEUTICALS SL
ES
List of nationally authorised medicinal products EMA/140794/2018
(IS) (IS) (IS) (IS)
UK UK UK UK
Page 218/220
Product Name (in authorisation country) Zytram 400 mg comprimidos de liberación prolongada Zytram BID 75 mg comprimidos de liberación prolongada ZYTRAM SR 100 mg prolonged release tablets ZYTRAM SR 150 mg prolonged release tablets ZYTRAM SR 200 mg prolonged release tablets ZYTRAM SR 75 mg prolonged release tablets ZYTRAM UNO 150 mg forðatöflur ZYTRAM UNO forðatöflur 200 mg ZYTRAM UNO forðatöflur 300 mg ZYTRAM UNO forðatöflur 400 mg ΣRΑΜΑL® Δλέζηκν δηάιπκα 100 mg/2ml AMP ΤRΑΜΑL® SR 100 mg δισκία παρατεταμένης αποδέσμευσης ΤRΑΜΑL® SR 150 mg δισκία παρατεταμένης αποδέσμευσης ΤRΑΜΑL® SR 200 mg δισκία παρατεταμένης αποδέσμευσης ΤRΑΜΑL® SR 50 mg δισκία παρατεταμένης αποδέσμευσης
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UK/H/0306/004
63.133
MUNDIPHARMA PHARMACEUTICALS SL
ES
UK/H/0330/001
63.134
MUNDIPHARMA PHARMACEUTICALS SL
ES
UK/H/0330/002
PL 16950/0102
UK
UK/H/0330/003
PL 16950/0103
UK/H/0330/004
PL 16950/0104
UK/H/0330/001
PL 16950/0101
not available
970442 (IS)
NAPP PHARMACEUTICALS LTD NAPP PHARMACEUTICALS LTD NAPP PHARMACEUTICALS LTD NAPP PHARMACEUTICALS LTD NORPHARMA A/S
not available
970443
NORPHARMA A/S
IS
not available
970444
NORPHARMA A/S
IS
not available
970445
NORPHARMA A/S
IS
not available
61457
VIANEX S.A.
GR
not available
22043/15/06-03-2017
VIANEX S.A.
GR
not available
22044/15/06-03-2017
VIANEX S.A.
GR
not available
22045/15/06-03-2017
VIANEX S.A.
GR
not available
22042/15/06-03-2017
VIANEX S.A.
GR
List of nationally authorised medicinal products EMA/140794/2018
UK UK UK IS
Page 219/220
Product Name (in authorisation country) ΤRΑΜΑL® Υπόθετα 100 mg Маброн 50 mg капсули Маброн 50 mg/ml инжекционен разтвор Маброн MR 100 mg таблетки с удължено освобождаване Маброн MR 150 mg таблетки с удължено освобождаване Маброн MR 200 mg таблетки с удължено освобождаване Трамадол STADA 50 mg капсула, твърда Трамадол STADA 50 mg капсула, твърда Трамадол STADA 50 mg/ml инжекционен разтвор Трамадол STADA 50 mg/ml инжекционен разтвор Трамалгин 50 mg твърди капсули Трамалгин 50 mg/ml инжекционен разтвор
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
not available not available not available
54399/12 20030082 20030083
VIANEX S.A. MEDOCHEMIE LTD. MEDOCHEMIE LTD.
GR BG BG
not available
20100447
MEDOCHEMIE LTD.
BG
not available
20100448
MEDOCHEMIE LTD.
BG
not available
20100449
MEDOCHEMIE LTD.
BG
not available
9600290
STADA ARZNEIMITTEL AG
BG
not available
9600290
STADA ARZNEIMITTEL AG
BG
not available
9600289
STADA ARZNEIMITTEL AG
BG
not available
9600289
STADA ARZNEIMITTEL AG
BG
not available
20030660
UNIPHARM
BG
not available
20050203
SOPHARMA AD
BG
List of nationally authorised medicinal products EMA/140794/2018
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