21 June 2017 EMA/610895/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: felbamate
Procedure no.: PSUSA/00010155/201609
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
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© European Medicines Agency, 2017. 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
Taloxa®-TABS600 mg Tabletten
FR/H/0061/002
BE171823
MSD BELGIUM BVBA/SPRL
BE
Taloxa®-SUSP 600 mg/5 ml Suspension zum Einnehmen
FR/H/0061/003
BE171832
MSD BELGIUM BVBA/SPRL
BE
Taloxa®-TABS 400 mg Tabletten
FR/H/0061/001
BE171945
MSD BELGIUM BVBA/SPRL
BE
Taloxa®-SUSP, 600 mg/5 ml suspensie voor oraal gebruik
FR/H/0061/003
BE 375112
MSD BELGIUM BVBA/SPRL
BE
Taloxa®-SUSP 600 mg/5 ml suspension buvable
FR/H/0061/003
BE375112
MSD BELGIUM BVBA/SPRL
BE
Taloxa®-SUSP 600 mg/5 ml Suspension zum Einnehmen
FR/H/0061/003
BE375112
MSD BELGIUM BVBA/SPRL
BE
Taloxa®-TABS 600 mg comprimés
FR/H/0061/002
BE375103
MSD BELGIUM BVBA/SPRL
BE
Taloxa®-TABS600 mg Tabletten
FR/H/0061/002
BE375103
MSD BELGIUM BVBA/SPRL
BE
Taloxa-TABS 600 mg tabletten
FR/H/0061/002
BE375103
MSD BELGIUM BVBA/SPRL
BE
List of nationally authorised medicinal products EMA/610895/2017
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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
Taloxa®-TABS 400 mg comprimés
FR/H/0061/001
BE375094
MSD BELGIUM BVBA/SPRL
BE
Taloxa®-TABS 400 mg tabletten
FR/H/0061/001
BE375094
MSD BELGIUM BVBA/SPRL
BE
Taloxa®-TABS 400 mg Tabletten
FR/H/0061/001
BE375094
MSD BELGIUM BVBA/SPRL
BE
TALOXA 400 mg, comprimé
FR/H/0061/001
34009 559 241 3 5
MSD FRANCE
FR
TALOXA 400 mg, comprimé
FR/H/0061/001
34009 559 173 8 0
MSD FRANCE
FR
TALOXA 400 mg, comprimé
FR/H/0061/001
34009 559 171 5 1
MSD FRANCE
FR
TALOXA 400 mg, comprimé
FR/H/0061/001
34009 559 169 0 1
MSD FRANCE
FR
TALOXA 400 mg, comprimé
FR/H/0061/001
34009 559 167 8 9
MSD FRANCE
FR
TALOXA 400 mg, comprimé
FR/H/0061/001
34009 559 240 7 4
MSD FRANCE
FR
List of nationally authorised medicinal products EMA/610895/2017
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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
TALOXA 400 mg, comprimé
FR/H/0061/001
34009 559 172 1 2
MSD FRANCE
FR
TALOXA 400 mg, comprimé
FR/H/0061/001
34009 559 170 9 0
MSD FRANCE
FR
TALOXA 400 mg, comprimé
FR/H/0061/001
34009 559 166 1 1
MSD FRANCE
FR
TALOXA 400 mg, comprimé
FR/H/0061/001
34009 559 168 4 0
MSD FRANCE
FR
TALOXA 600 mg, comprimé
FR/H/0061/002
34009 559 252 5 5
MSD FRANCE
FR
TALOXA 600 mg, comprimé
FR/H/0061/002
34009 559 250 2 6
MSD FRANCE
FR
TALOXA 600 mg, comprimé
FR/H/0061/002
34009 559 248 8 3
MSD FRANCE
FR
TALOXA 600 mg, comprimé
FR/H/0061/002
34009 559 246 5 4
MSD FRANCE
FR
TALOXA 600 mg, comprimé
FR/H/0061/002
34009 559 244 2 5
MSD FRANCE
FR
List of nationally authorised medicinal products EMA/610895/2017
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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
TALOXA 600 mg, comprimé
FR/H/0061/002
34009 559 251 9 4
MSD FRANCE
FR
TALOXA 600 mg, comprimé
FR/H/0061/002
34009 559 249 4 4
MSD FRANCE
FR
TALOXA 600 mg, comprimé
FR/H/0061/002
34009 559 247 1 5
MSD FRANCE
FR
TALOXA 600 mg, comprimé
FR/H/0061/002
34009 559 243 6 4
MSD FRANCE
FR
TALOXA 600 mg/5 ml, suspension buvable
FR/H/0061/003
34009 559 165 5 0
MSD FRANCE
FR
TALOXA 600 mg/5 ml, suspension buvable
FR/H/0061/003
34009 559 162 6 0
MSD FRANCE
FR
TALOXA 600 mg/5 ml, suspension buvable
FR/H/0061/003
34009 559 159 5 9
MSD FRANCE
FR
TALOXA 600 mg/5 ml, suspension buvable
FR/H/0061/003
34009 559 163 2 1
MSD FRANCE
FR
TALOXA 600 mg/5 ml, suspension buvable
FR/H/0061/003
34009 559 160 3 1
MSD FRANCE
FR
List of nationally authorised medicinal products EMA/610895/2017
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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
TALOXA 600 mg/5 ml sospensione orale
FR/H/0061/003
030822011
MSD ITALIA S.R.L.
IT
Taloxa-TABS 600 mg tabletten
FR/H/0061/002
RVG 110909
MERCK SHARP & DOHME BV
NL
TALOXA 400 mg compresse
FR/H/0061/001
030822023
MSD ITALIA S.R.L.
IT
Taloxa 600 mg comprimidos
FR/H/0061/002
4006185
MERCK SHARP & DOHME, LDA.
PT
Taloxa 600 mg comprimidos
FR/H/0061/002
4005989
MERCK SHARP & DOHME, LDA.
PT
Taloxa 600 mg comprimidos
FR/H/0061/002
4001889
MERCK SHARP & DOHME, LDA.
PT
TALOXA 600 mg, comprimé
FR/H/0061/002
34009 559 245 9 3
MSD FRANCE
FR
Taloxa 600 mg comprimidos
FR/H/0061/002
4001988
MERCK SHARP & DOHME, LDA.
PT
TALOXA 600 mg compresse
FR/H/0061/002
030822035
MSD ITALIA S.R.L.
IT
List of nationally authorised medicinal products EMA/610895/2017
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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
TALOXA 600, 600 mg, Tabletten
FR/H/0061/002
30639.01.00
MSD SHARP & DOHME GMBH
DE
Taloxa 600 mg comprimidos
FR/H/0061/002
4006086
MERCK SHARP & DOHME, LDA.
PT
Taloxa 600 mg comprimidos
FR/H/0061/002
4001681
MERCK SHARP & DOHME, LDA.
PT
Taloxa 600 mg comprimidos
FR/H/0061/002
2323186
MERCK SHARP & DOHME, LDA.
PT
Taloxa 600 mg comprimidos
FR/H/0061/002
4005781
MERCK SHARP & DOHME, LDA.
PT
Taloxa 600 mg comprimidos
FR/H/0061/002
4005880
MERCK SHARP & DOHME, LDA.
PT
Taloxa 600 mg comprimidos
FR/H/0061/002
4001780
MERCK SHARP & DOHME, LDA.
PT
Taloxa 600 mg/5 ml suspensão oral
FR/H/0061/003
4004784
MERCK SHARP & DOHME, LDA.
PT
Taloxa 600 mg/5 ml suspensão oral
FR/H/0061/003
4004685
MERCK SHARP & DOHME, LDA.
PT
List of nationally authorised medicinal products EMA/610895/2017
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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
Taloxa 600 mg/5 ml suspensão oral
FR/H/0061/003
4006284
MERCK SHARP & DOHME, LDA.
PT
Taloxa 600 mg/5 ml suspensão oral
FR/H/0061/003
2410793
MERCK SHARP & DOHME, LDA.
PT
TALOXA 600 mg/5 ml, suspension buvable
FR/H/0061/003
34009 559 158 9 8
MSD FRANCE
FR
Taloxa 600 mg/5 ml suspensão oral
FR/H/0061/003
2323285
MERCK SHARP & DOHME, LDA.
PT
Taloxa 600 mg/5 ml suspensão oral
FR/H/0061/003
4006383
MERCK SHARP & DOHME, LDA.
PT
Taloxa 600 mg/5 ml suspensão oral
FR/H/0061/003
2410785
MERCK SHARP & DOHME, LDA.
PT
Taloxa-SUSP, 600 mg/5 ml suspensie voor oraal gebruik
FR/H/0061/003
RVG 16889
MERCK SHARP & DOHME BV
NL
TALOXA Saft, 600 mg/5 ml, Suspension zum Einnehmen
FR/H/0061/003
30639.00.01
MSD SHARP & DOHME GMBH
DE
Taloxa 600 mg/5 ml suspensão oral
FR/H/0061/003
4006482
MERCK SHARP & DOHME, LDA.
PT
List of nationally authorised medicinal products EMA/610895/2017
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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
Taloxa 600 mg/5 ml suspensão oral
FR/H/0061/003
2323293
MERCK SHARP & DOHME, LDA.
PT
Taloxa®-TABS 400 mg comprimés
FR/H/0061/001
BE171945
MSD BELGIUM BVBA/SPRL
BE
Taloxa-TABS 600 mg comprimés
FR/H/0061/002
BE171823
MSD BELGIUM BVBA/SPRL
BE
Taloxa®-TABS 400 mg tabletten
FR/H/0061/001
BE171945
MSD BELGIUM BVBA/SPRL
BE
Taloxa-TABS 600 mg comprimés
FR/H/0061/002
2011010925
MSD BELGIUM BVBA/SPRL
LU
Taloxa®-TABS 400 mg comprimés
FR/H/0061/001
2011010924
MSD BELGIUM BVBA/SPRL
LU
Taloxa®-SUSP 600 mg/5 ml suspension buvable
FR/H/0061/003
1995120385
MSD BELGIUM BVBA/SPRL
LU
Taloxa®-SUSP 600 mg/5 ml suspension buvable
FR/H/0061/003
BE171832
MSD BELGIUM BVBA/SPRL
BE
Taloxa®-SUSP, 600 mg/5 ml suspensie voor oraal gebruik
FR/H/0061/003
BE 171832
MSD BELGIUM BVBA/SPRL
BE
List of nationally authorised medicinal products EMA/610895/2017
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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
Taloxa-TABS 600 mg tabletten
FR/H/0061/002
BE171823
MSD BELGIUM BVBA/SPRL
BE
Taloxa 600 mg/5 ml orale Suspension
not available
1-21405
MERCK SHARP & DOHME GES.M.B.H.
AT
Taloxa 600 mg Tabletten
not available
1-21407
MERCK SHARP & DOHME GES.M.B.H.
AT
Taloxa 600 mg/5 ml orale Suspension
not available
1-21405
MERCK SHARP & DOHME GES.M.B.H.
AT
Taloxa 600 mg Tabletten
not available
1-21407
MERCK SHARP & DOHME GES.M.B.H.
AT
TALOXA 600 mg tabletter
not available
8224
MERCK SHARP & DOHME BV
NO
Taloxa 600 mg tabletter
not available
12705
MERCK SHARP & DOHME BV
SE
Taloxa 120 mg/ml oral suspension
not available
12706
MERCK SHARP & DOHME BV
SE
Taloxa 600 mg tabletta
not available
OGYI-T-5129/02
MSD PHARMA HUNGARY KFT.
HU
List of nationally authorised medicinal products EMA/610895/2017
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Product Name (in authorisation country) TALOXA 120 mg/ml mikstur, suspensjon
MRP/DCP Authorisation number not available
List of nationally authorised medicinal products EMA/610895/2017
National Authorisation Number
8222
MAH of product in the member state MERCK SHARP & DOHME BV
Member State where product is authorised NO
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