8 March 2018 EMA/135395/2018 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: theophylline
Procedure No.: PSUSA/00002921/201706
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)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
DILATRANE 1 POUR
not available
V07675-3400930317808
SOCIETE D'ETUDES ET DE
FR
CENT, sirop
RECHERCHES PHARMACEUTIQUES (SERP)
DILATRANE 100 mg,
not available
V07674-3400930317747
SOCIETE D'ETUDES ET DE
gélule à libération
RECHERCHES
prolongée
PHARMACEUTIQUES (SERP)
Theophyllin STADA® 400
FR
not available
31200.00.00
STADAPHARM GMBH
DE
not available
PL 11648/0080
MERCK SERONO LTD.
UK
not available
PL 11648/0081
MERCK SERONO LTD.
UK
not available
PL 11648/0079
MERCK SERONO LTD.
UK
not available
2707.00.00
SANOFI-AVENTIS
DE
mg Hartkapseln, retardiert Slo-Phyllin 125 mg Capsules Slo-Phyllin 250 mg Capsules Slo-Phyllin 60 mg Capsules SOLOSIN RETARD
DEUTSCHLAND GMBH SOLOSIN RETARD
not available
2707.00.00
SANOFI-AVENTIS
DE
DEUTSCHLAND GMBH SOLOSIN
not available
2707.00.01
INFUSIONSLÖSUNGSKON
SANOFI-AVENTIS
DE
DEUTSCHLAND GMBH
ZENTRAT SOLOSIN
not available
INFUSIONSLÖSUNGSKON
2707.00.01
SANOFI-AVENTIS
DE
DEUTSCHLAND GMBH
ZENTRAT List of nationally authorised medicinal products EMA/135395/2018
Page 2/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
SOLOSIN RETARD MITE
not available
2707.01.00
SANOFI-AVENTIS
DE
DEUTSCHLAND GMBH SOLOSIN RETARD
not available
2707.00.00
SANOFI-AVENTIS
DE
DEUTSCHLAND GMBH SOLOSIN RETARD
not available
2707.00.00
SANOFI-AVENTIS
DE
DEUTSCHLAND GMBH SOLOSIN RETARD
not available
2707.00.00
SANOFI-AVENTIS
DE
DEUTSCHLAND GMBH SOLOSIN
not available
2707.00.01
INFUSIONSLÖSUNGSKON
SANOFI-AVENTIS
DE
DEUTSCHLAND GMBH
ZENTRAT SOLOSIN RETARD MITE
not available
2707.01.00
SANOFI-AVENTIS
DE
DEUTSCHLAND GMBH SOLOSIN RETARD MITE
not available
2707.01.00
SANOFI-AVENTIS
DE
DEUTSCHLAND GMBH SOLOSIN RETARD MITE
not available
2707.01.00
SANOFI-AVENTIS
DE
DEUTSCHLAND GMBH SOLOSIN RETARD MITE
not available
2707.01.00
SANOFI-AVENTIS
DE
DEUTSCHLAND GMBH
List of nationally authorised medicinal products EMA/135395/2018
Page 3/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Theo-Dur 200mg
not available
6607
BIOPHAUSIA AB
NO
not available
6608
BIOPHAUSIA AB
NO
not available
1.891
TAKEDA GMBH (KONSTANZ)
ES
not available
025267016
RECORDATI INDUSTRIA
IT
depottablett Theo-Dur 300mg depottablett Eufilina Venosa 200 mg solución inyectable Theo-dur 300 mg compresse a rilascio
CHIMICA E FARMACEUTICA
prolungato Theo-dur 200 mg
S.P.A. not available
025267028
RECORDATI INDUSTRIA
compresse a rilascio
CHIMICA E FARMACEUTICA
prolungato
S.P.A.
Nuelin Depot 175 mg
IT
not available
8131
MEDA OY
FI
not available
8792
MEDA OY
FI
not available
8132
MEDA OY
FI
not available
56160
MEDA PHARMA S.A.U.
ES
depottabletter Nuelin Depot 350 mg depottabletter Nuelin Depot 250 mg depottabletter Theolair 175 mg, comprimidos de liberación prolongada
List of nationally authorised medicinal products EMA/135395/2018
Page 4/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Theolair 250 mg,
not available
56161
MEDA PHARMA S.A.U.
ES
not available
025730019
MEDA PHARMA S.P.A.
IT
not available
025730021
MEDA PHARMA S.P.A.
IT
not available
6590
MEDA AS
NO
not available
6600
MEDA AS
NO
not available
8131
MEDA OY
FI
not available
8132
MEDA OY
FI
not available
8792
MEDA OY
FI
not available
RVG 09107
MEDA PHARMA B.V.
NL
comprimidos de liberación prolongada THEOLAIR compresse a rilascio prolungato THEOLAIR compresse a rilascio prolungato Nuelin Depot 250 mg depottablett Nuelin Depot 350 mg depottablett Nuelin Depot 175 mg depottabletit Nuelin Depot 250 mg depottabletti Nuelin Depot 350 mg depottabletti Theolair Retard 175, tabletten met gereguleerde afgifte 175 mg
List of nationally authorised medicinal products EMA/135395/2018
Page 5/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Theolair Retard 250,
not available
RVG 08391
MEDA PHARMA B.V.
NL
not available
RVG 08816
MEDA PHARMA B.V.
NL
not available
10557
MEDA AS
DK
not available
10262
MEDA AS
DK
not available
BE128502
LABORATOIRES SMB S.A.
BE
not available
BE 128502
LABORATOIRES SMB S.A.
BE
not available
BE 128502
LABORATOIRES SMB S.A.
BE
not available
0160/99/01/4904
LABORATOIRES SMB S.A.
LU
not available
0160/99/01/4904
LABORATOIRES SMB S.A.
LU
tabletten met gereguleerde afgifte 250 mg Theolair Retard 350, tabletten met gereguleerde afgifte 350 mg Nuelin Retard, depottabletter Nuelin Retard, depottabletter PEDIAPHYLLIN 200 mg Comprimé à libération prolongée PEDIAPHYLLIN 200 mg, tablet met verlengde afgifte PEDIAPHYLLIN 200 mg Retardtablette PEDIAPHYLLIN 200 mg Comprimé à libération prolongée PEDIAPHYLLIN 200 mg Retardtablette
List of nationally authorised medicinal products EMA/135395/2018
Page 6/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Xanthium 200 mg Gélules
not available
BE138573
LABORATOIRES SMB S.A.
BE
not available
BE158365
LABORATOIRES SMB S.A.
BE
not available
BE158365
LABORATOIRES SMB S.A.
BE
not available
BE138573
LABORATOIRES SMB S.A.
BE
not available
BE138564
LABORATOIRES SMB S.A.
BE
not available
BE138564
LABORATOIRES SMB S.A.
BE
not available
BE158365
LABORATOIRES SMB S.A.
BE
not available
BE138573
LABORATOIRES SMB S.A.
BE
not available
BE138564
LABORATOIRES SMB S.A.
BE
à libération prolongée Xanthium 300 mg Gélules à libération prolongée Xanthium 300 mg Capsule met verlengde afgifte, hard Xanthium 200 mg Hartkapseln, retardiert Xanthium 400 mg Gélules à libération prolongée Xanthium 400 mg Hartkapseln, retardiert Xanthium 300 mg Hartkapseln, retardiert Xanthium 200 mg Capsule met verlengde afgifte, hard Xanthium 400 mg Capsule met verlengde afgifte, hard
List of nationally authorised medicinal products EMA/135395/2018
Page 7/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Xanthium 200 mg Gélules
not available
2002116791
LABORATOIRES SMB S.A.
LU
not available
2002116791
LABORATOIRES SMB S.A.
LU
not available
2002116792
LABORATOIRES SMB S.A.
LU
not available
2002116792
LABORATOIRES SMB S.A.
LU
not available
2002116793
LABORATOIRES SMB S.A.
LU
not available
2002116793
LABORATOIRES SMB S.A.
LU
not available
NL13804-3400932787821
SOCIETE D'ETUDES ET DE
FR
à libération prolongée Xanthium 200 mg Hartkapseln, retardiert Xanthium 300 mg Gélules à libération prolongée Xanthium 300 mg Hartkapseln, retardiert Xanthium 400 mg Gélules à libération prolongée Xanthium 400 mg Hartkapseln, retardiert DILATRANE 50 mg, gélule à libération prolongée
RECHERCHES PHARMACEUTIQUES (SERP)
Theo-Dur 300 mg
not available
9446
BIOPHAUSIA AB
SE
not available
9445
BIOPHAUSIA AB
SE
depottabletter Theo-Dur 200 mg depottabletter
List of nationally authorised medicinal products EMA/135395/2018
Page 8/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UNIPHYLLIN® Ελιξίριο
not available
8570/06.02.2007
UNI-PHARMA KLEON TSETIS
GR
50mg/5ml
PHARMACEUTICAL LABORATORIES S.A.
UNIPHYLLIN® Σιρόπι
not available
8570/06.02.2007
50mg/5ml
UNI-PHARMA KLEON TSETIS
GR
PHARMACEUTICAL LABORATORIES S.A.
UNIPHYLLIN® Δισκία
not available
8570/06.02.2007
βραδείας αποδέσμευσης 100mg/tab UNIPHYLLIN® Δισκία
UNI-PHARMA KLEON TSETIS LABORATORIES S.A.
not available
8570/06.02.2007
UNI-PHARMA KLEON TSETIS
βραδείας αποδέσμευσης
PHARMACEUTICAL
200mg/tab
LABORATORIES S.A.
UNIPHYLLIN® Δισκία
not available
8570/06.02.2007
UNI-PHARMA KLEON TSETIS
βραδείας αποδέσμευσης
PHARMACEUTICAL
300mg/tab
LABORATORIES S.A.
UNIPHYLLIN® Κάψουλες
not available
8570/06.02.2007
UNI-PHARMA KLEON TSETIS
βραδείας αποδέσμευσης
PHARMACEUTICAL
100mg/cap
LABORATORIES S.A.
UNIPHYLLIN Κάψουλες
not available
8570/06.02.2007
βραδείας αποδέσμευσης
UNI-PHARMA KLEON TSETIS
GR
GR
GR
GR
PHARMACEUTICAL
350mg/cap UNIPHYLLIN® Υπόθετα
GR
PHARMACEUTICAL
LABORATORIES S.A. not available
8570/06.02.2007
100mg/supp
UNI-PHARMA KLEON TSETIS
GR
PHARMACEUTICAL LABORATORIES S.A.
UNIPHYLLIN® Υπόθετα
not available
350mg/supp
8570/06.02.2007
UNI-PHARMA KLEON TSETIS
GR
PHARMACEUTICAL LABORATORIES S.A.
List of nationally authorised medicinal products EMA/135395/2018
Page 9/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UNIPHYLLIN, Eνέσιμο
not available
8570/06.02.2007
UNI-PHARMA KLEON TSETIS
GR
διάλυμα 240(218)mg/4ml
PHARMACEUTICAL
Amp
LABORATORIES S.A.
DILATRANE 200 mg,
not available
V07672-3400930317686
SOCIETE D'ETUDES ET DE
gélule à libération
RECHERCHES
prolongée
PHARMACEUTIQUES (SERP)
TEDRALAN 200 mg,
not available
VNL6671-3400931035398
gélule à libération
SOCIETE D'ETUDES ET DE
FR
FR
RECHERCHES
prolongée
PHARMACEUTIQUES (SERP)
Theo-Dur, depottabletter
not available
10044
BIOPHAUSIA AB
DK
Theo-Dur, depottabletter
not available
10045
BIOPHAUSIA AB
DK
Euphyllin long, 300 mg,
not available
4502
ASTRAZENECA AB
PL
not available
14/0135/94-S
ASTRAZENECA AB
SK
not available
4501
ASTRAZENECA AB
PL
not available
14/0003/13-S
ASTRAZENECA AB
SK
kapsulki o zmodyfikowanym uwalnianiu, twarde EUPHYLLIN CR N 200 kapsuly s predĺženým uvoľňovaním Euphyllin long, 200 mg, kapsułki o zmodyfikowanym uwalnianiu, twarde EUPHYLLIN CR N 300 kapsuly s predĺženým uvoľňovaním List of nationally authorised medicinal products EMA/135395/2018
Page 10/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
EUPHYLLIN CR N 400
not available
14/0004/13-S
ASTRAZENECA AB
SK
not available
14/078/99-C
ASTRAZENECA AB
CZ
not available
14/079/99-C
ASTRAZENECA AB
CZ
not available
14/080/99-C
ASTRAZENECA AB
CZ
not available
14/081/99-C
ASTRAZENECA AB
CZ
not available
025267016
RECORDATI INDUSTRIA
IT
kapsuly s predĺženým uvoľňovaním Euphyllin CR N 100 Tvrdá tobolka s prodlouženým uvolňováním Euphyllin CR N 200 Tvrdá tobolka s prodlouženým uvolňováním Euphyllin CR N 300 Tvrdá tobolka s prodlouženým uvolňováním Euphyllin CR N 400 Tvrdá tobolka s prodlouženým uvolňováním Theo-dur 300 mg compresse a rilascio
CHIMICA E FARMACEUTICA
prolungato
S.P.A.
Theo-dur 200 mg
not available
025267028
compresse a rilascio
RECORDATI INDUSTRIA
IT
CHIMICA E FARMACEUTICA
prolungato
S.P.A.
THEO-DUR®
not available
42686/09/12-2-2010
LAVIPHARM S.A
GR
THEO-DUR®
not available
42687/09/12-2-2010
LAVIPHARM S.A
GR
List of nationally authorised medicinal products EMA/135395/2018
Page 11/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
THEO-DUR®
not available
20100
LAVIPHARM LIMITED
CY
THEO-DUR®
not available
20099
LAVIPHARM LIMITED
CY
DILATRANE 300 mg,
not available
NL13805-3400932787999
SOCIETE D'ETUDES ET DE
FR
gélule à libération
RECHERCHES
prolongée
PHARMACEUTIQUES (SERP)
DIFFUMAL
not available
025740085
MALESCI ISTITUTO
IT
FARMACOBIOLOGICO S.P.A. DIFFUMAL
not available
025740097
MALESCI ISTITUTO
IT
FARMACOBIOLOGICO S.P.A. AMINOMAL 0,67%
not available
011226091
MALESCI ISTITUTO
soluzione orale (67
FARMACOBIOLOGICO -
mg/10 ml)
S.P.A.
AFONILUM SR 125 125
IT
not available
14/0595/94-S
BGP PRODUCTS S.R.O.
SK
not available
14/0595/94-S
BGP PRODUCTS S.R.O.
SK
not available
14/0595/94-S
BGP PRODUCTS S.R.O.
SK
mg, kapsuly s predlženým uvolnovaním AFONILUM SR 250 250 mg, kapsuly s predlženým uvolnovaním AFONILUM SR 375 375mg|kapsuly s predlženým uvolnovaním
List of nationally authorised medicinal products EMA/135395/2018
Page 12/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
THEOSTAT 100 mg A
not available
326 913-9
PIERRE FABRE MEDICAMENT
FR
not available
327 873.0
SAS PIERRE FABRE
FR
LIBERATION PROLONGEE, comprimé sécable THEOSTAT LP 200 mg, comprimé sécable à
MEDICAMENT
libération prolongée THEOSTAT 300 mg A
not available
34009 326 021 0 0
PIERRE FABRE MEDICAMENT
FR
not available
327 874.7
PIERRE FABRE MEDICAMENT
FR
not available
327 875.3
PIERRE FABRE MEDICAMENT
FR
not available
327 877.6
PIERRE FABRE MEDICAMENT
FR
not available
554 929.7
PIERRE FABRE MEDICAMENT
FR
not available
326 914-5
PIERRE FABRE MEDICAMENT
FR
LIBERATION PROLONGEE, comprimé sécable THEOSTAT LP 200 mg, comprimé sécable à libération prolongée THEOSTAT LP 200 mg, comprimé sécable à libération prolongée THEOSTAT LP 200 mg, comprimé sécable à libération prolongée THEOSTAT LP 200 mg, comprimé sécable à libération prolongée THEOSTAT 100 mg A LIBERATION PROLONGEE, comprimé sécable
List of nationally authorised medicinal products EMA/135395/2018
Page 13/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
THEOSTAT 100 mg A
not available
326 915-1
PIERRE FABRE MEDICAMENT
FR
not available
327 138-9
PIERRE FABRE MEDICAMENT
FR
not available
554 701-6
PIERRE FABRE MEDICAMENT
FR
not available
556 814-2
PIERRE FABRE MEDICAMENT
FR
not available
34009 327 314 1 1
PIERRE FABRE MEDICAMENT
FR
not available
34009 554 187 0 2
PIERRE FABRE MEDICAMENT
FR
not available
14/900//92-C
PIERRE FABRE MEDICAMENT
CZ
LIBERATION PROLONGEE, comprimé sécable THEOSTAT 100 mg A LIBERATION PROLONGEE, comprimé sécable THEOSTAT 100 mg A LIBERATION PROLONGEE, comprimé sécable THEOSTAT 100 mg A LIBERATION PROLONGEE, comprimé sécable THEOSTAT 300 mg A LIBERATION PROLONGEE, comprimé sécable THEOSTAT 300 mg A LIBERATION PROLONGEE, comprimé sécable THEOPLUS 100 Tableta s prodlouženým uvolňováním
List of nationally authorised medicinal products EMA/135395/2018
Page 14/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
THEOPLUS 100
not available
14/0900/92-S
SAS PIERRE FABRE
SK
MEDICAMENT THEOPLUS 300 Tableta s
not available
14/900/92- A/C
PIERRE FABRE MEDICAMENT
CZ
THEOPLUS 300
not available
14/900/92-S
PIERRE FABRE MEDICAMENT
SK
Theophyllin STADA® 200
not available
33294.01.00
STADAPHARM GMBH
DE
not available
33294.02.00
STADAPHARM GMBH
DE
not available
BE128502
LABORATOIRES SMB S.A.
BE
not available
BE 128502
LABORATOIRES SMB S.A.
BE
not available
BE 128502
LABORATOIRES SMB S.A.
BE
not available
0160/99/01/4904
LABORATOIRES SMB S.A.
LU
prodlouženým uvolňováním
mg Hartkapseln, retardiert Theophyllin STADA® 300 mg Hartkapseln, retardiert PEDIAPHYLLIN 200 mg Comprimé à libération prolongée PEDIAPHYLLIN 200 mg, tablet met verlengde afgifte PEDIAPHYLLIN 200 mg Retardtablette PEDIAPHYLLIN 200 mg Comprimé à libération prolongée
List of nationally authorised medicinal products EMA/135395/2018
Page 15/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
PEDIAPHYLLIN 200 mg
not available
0160/99/01/4904
LABORATOIRES SMB S.A.
LU
not available
BE138573
LABORATOIRES SMB S.A.
BE
not available
BE158365
LABORATOIRES SMB S.A.
BE
not available
BE158365
LABORATOIRES SMB S.A.
BE
not available
BE138573
LABORATOIRES SMB S.A.
BE
not available
BE138564
LABORATOIRES SMB S.A.
BE
not available
BE138564
LABORATOIRES SMB S.A.
BE
not available
BE158365
LABORATOIRES SMB S.A.
BE
not available
BE138573
LABORATOIRES SMB S.A.
BE
Retardtablette Xanthium 200 mg Gélules à libération prolongée Xanthium 300 mg Gélules à libération prolongée Xanthium 300 mg Capsule met verlengde afgifte, hard Xanthium 200 mg Hartkapseln, retardiert Xanthium 400 mg Gélules à libération prolongée Xanthium 400 mg Hartkapseln, retardiert Xanthium 300 mg Hartkapseln, retardiert Xanthium 200 mg Capsule met verlengde afgifte, hard
List of nationally authorised medicinal products EMA/135395/2018
Page 16/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Xanthium 400 mg
not available
BE138564
LABORATOIRES SMB S.A.
BE
not available
2002116791
LABORATOIRES SMB S.A.
LU
not available
2002116791
LABORATOIRES SMB S.A.
LU
not available
2002116792
LABORATOIRES SMB S.A.
LU
not available
2002116792
LABORATOIRES SMB S.A.
LU
not available
2002116793
LABORATOIRES SMB S.A.
LU
not available
2002116793
LABORATOIRES SMB S.A.
LU
not available
21810.00.01
TAKEDA GMBH (KONSTANZ)
DE
not available
3003022.01.00
TAKEDA GMBH (KONSTANZ)
DE
Capsule met verlengde afgifte, hard Xanthium 200 mg Gélules à libération prolongée Xanthium 200 mg Hartkapseln, retardiert Xanthium 300 mg Gélules à libération prolongée Xanthium 300 mg Hartkapseln, retardiert Xanthium 400 mg Gélules à libération prolongée Xanthium 400 mg Hartkapseln, retardiert Euphylong® i.v. 200, 200 mg, Injektionslösung Euphylong® 200 mg, Hartkapsel, retardiert
List of nationally authorised medicinal products EMA/135395/2018
Page 17/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Euphylong® 250 mg,
not available
9689.00.00
TAKEDA GMBH (KONSTANZ)
DE
not available
027435078
TAKEDA ITALIA S.P.A.
IT
not available
24676.02.00
TAKEDA GMBH (KONSTANZ)
DE
not available
027435080
TAKEDA ITALIA S.P.A.
IT
not available
3003022.00.00
TAKEDA GMBH (KONSTANZ)
DE
not available
34009 338 494 6 7
TAKEDA FRANCE S.A.S.
FR
not available
R/6654
TAKEDA PHARMA SP.Z.O.O.
PL
not available
027435155
TAKEDA ITALIA S.P.A.
IT
not available
34009 333 752 7 0
TAKEDA FRANCE S.A.S.
FR
Hartkapsel, retardiert Respicur 400 mg capsule rigide a rilascio prolungato Euphylong® 125 mg, Hartkapsel, retardiert Respicur 200 mg capsule rigide a rilascio prolungato Euphylong® 300 mg, Hartkapsel, retardiert EUPHYLLINE L.A. 400 mg, gélule à libération prolongée Euphyllin CR retard, 250 mg, tabletki o przedłużonym uwalnianiu Respicur 300 mg capsule rigide a rilascio prolungato EUPHYLLINE L.A. 100 mg, gélule à libération prolongée
List of nationally authorised medicinal products EMA/135395/2018
Page 18/22
Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
EUPHYLLINE L.A. 300
not available
34009 333 753 3 1
TAKEDA FRANCE S.A.S.
FR
not available
34009 555 162 1 7
TAKEDA FRANCE S.A.S.
FR
not available
34009 553 061 3 9
TAKEDA FRANCE S.A.S.
FR
not available
34009 325 016 3 2
TAKEDA FRANCE S.A.S.
FR
not available
34009 560 449 3 1
TAKEDA FRANCE S.A.S.
FR
not available
34009 333 751 0 2
TAKEDA FRANCE S.A.S.
FR
not available
34009 560 452 4 2
TAKEDA FRANCE S.A.S.
FR
not available
34009 328 014 1 1
TAKEDA FRANCE S.A.S.
FR
not available
34009 325 018 6 1
TAKEDA FRANCE S.A.S.
FR
mg, gélule à libération prolongée EUPHYLLINE L.A. 200 mg, gélule à libération prolongée EUPHYLLINE L.A. 100 mg, gélule à libération prolongée EUPHYLLINE L.A. 100 mg, gélule à libération prolongée EUPHYLLINE L.A. 100 mg, gélule à libération prolongée EUPHYLLINE L.A. 200 mg, gélule à libération prolongée EUPHYLLINE L.A. 200 mg, gélule à libération prolongée EUPHYLLINE L.A. 200 mg, gélule à libération prolongée EUPHYLLINE L.A. 300 mg, gélule à libération prolongée
List of nationally authorised medicinal products EMA/135395/2018
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
EUPHYLLINE L.A. 300
not available
34009 560 450 1 3
TAKEDA FRANCE S.A.S.
FR
not available
34009 553 063 6 8
TAKEDA FRANCE S.A.S.
FR
not available
34009 560 451 8 1
TAKEDA FRANCE S.A.S.
FR
not available
34009 555 168 8 5
TAKEDA FRANCE S.A.S.
FR
not available
34009 328 218 6 0
TAKEDA FRANCE S.A.S.
FR
not available
14/468/95-A/C
BGP PRODUCTS CZECH
CZ
mg, gélule à libération prolongée EUPHYLLINE L.A. 300 mg, gélule à libération prolongée EUPHYLLINE L.A. 400 mg, gélule à libération prolongée EUPHYLLINE L.A. 400 mg, gélule à libération prolongée EUPHYLLINE L.A. 400 mg, gélule à libération prolongée Afonilum SR 125 mg Tvrdá tobolka s
REPUBLIC S.R.O.
prodlouženým uvolňováním Afonilum SR 250 mg
not available
14/468/95-B/C
Tvrdá tobolka s
BGP PRODUCTS CZECH
CZ
REPUBLIC S.R.O.
prodlouženým uvolňováním Uniphyllin® 300 mg
not available
25497.00.00
MUNDIPHARMA GMBH
DE
Uniphyllin® 400 mg
not available
02738.00.00
MUNDIPHARMA GMBH
DE
List of nationally authorised medicinal products EMA/135395/2018
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
Uniphyllin® 600 mg
not available
02738.02.00
MUNDIPHARMA GMBH
DE
Unifyl retard 300 mg
not available
1-18815
MUNDIPHARMA GES.M.B.H
AT
not available
1-18171
MUNDIPHARMA GES.M.B.H
AT
not available
1-17835
MUNDIPHARMA GES.M.B.H
AT
not available
1-18818
MUNDIPHARMA GES.M.B.H
AT
not available
19865
MUNDIPHARMA
CY
Tabletten Unifyl retard 200 mg Tabletten Unifyl retard 400 mg Tabletten Unifyl retard 600 mg Tabletten UNIPHYLLIN CONTINUS tablets 400 mg UNIPHYLLIN®
PHARMACEUTICALS LTD not available
PA 1688/11/1
CONTINUS® 200 mg
MUNDIPHARMA
IE
PHARMACEUTICALS LIMITED
prolonged release tablets UNIPHYLLIN®
not available
PA 1688/11/2
CONTINUS® 300 mg
MUNDIPHARMA
IE
PHARMACEUTICALS LIMITED
prolonged release tablets UNIPHYLLIN®
not available
CONTINUS® 400 mg
PA 1688/11/3
MUNDIPHARMA
IE
PHARMACEUTICALS LIMITED
prolonged release tablets
List of nationally authorised medicinal products EMA/135395/2018
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Product Name (in authorisation country)
MRP/DCP Authorisation number
National Authorisation Number
MAH of product in the member state
Member State where product is authorised
UNIPHYLLIN CONTINUS
not available
PL 16950/0066
NAPP PHARMACEUTICALS
UK
200 mg prolonged
LTD
release tablets UNIPHYLLIN CONTINUS
not available
PL 16950/0067
300 mg prolonged
NAPP PHARMACEUTICALS
UK
LTD
release tablets UNIPHYLLIN CONTINUS
not available
PL 16950/0068
400 mg prolonged
NAPP PHARMACEUTICALS
UK
LTD
release tablets Unicontin 400 mg
not available
9628719
comprimidos de
MEDA PHARMA – PRODUTOS
PT
FARMACÊUTICOS, S.A.
libertação prolongada Unicontin 400 mg
not available
comprimidos de
9628727
MEDA PHARMA – PRODUTOS
PT
FARMACÊUTICOS, S.A.
libertação prolongada
List of nationally authorised medicinal products EMA/135395/2018
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