list of nationally authorised medicinal products...apotex europe b.v. pl epitoram, 50 mg, tabletki...
TRANSCRIPT
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An agency of the European Union Telephone +44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5525 Send a question via our website www.ema.europa.eu/contact
© European Medicines Agency, 2017. Reproduction is authorised provided the source is acknowledged.
1 September 2017 EMA/641616/2017 Human Medicines Evaluation Division
List of nationally authorised medicinal products
Active substance: topiramate
Procedure no.: PSUSA/00002996/201701
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List of nationally authorised medicinal products EMA/641616/2017 Page 2/221
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
Acomicil 100 mg comprimidos recubiertos con película EFG
not available 69.661 ADAMED LABORATORIOS, S.L.U.
ES
Acomicil 200 mg comprimidos recubiertos con película EFG
not available 69.662 ADAMED LABORATORIOS, S.L.U.
ES
Acomicil 25 mg comprimidos recubiertos con película EFG
not available 69.659 ADAMED LABORATORIOS, S.L.U.
ES
Acomicil 50 mg comprimidos recubiertos con película EFG
not available 69.660 ADAMED LABORATORIOS, S.L.U.
ES
ECURAM 100 mg compresse rivestite con film
AT/H/0612/003 039937115 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 100 mg compresse rivestite con film
AT/H/0612/003 039937127 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 100 mg compresse rivestite con film
AT/H/0612/003 039937139 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 100 mg compresse rivestite con film
AT/H/0612/003 039937141 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 100 mg compresse rivestite con film
AT/H/0612/003 039937154 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 200 mg compresse rivestite con film
AT/H/0612/004 039937166 BLUEFISH PHARMACEUTICALS AB
IT
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List of nationally authorised medicinal products EMA/641616/2017 Page 3/221
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
ECURAM 200 mg compresse rivestite con film
AT/H/0612/004 039937178 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 200 mg compresse rivestite con film
AT/H/0612/004 039937180 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 200 mg compresse rivestite con film
AT/H/0612/004 039937192 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 200 mg compresse rivestite con film
AT/H/0612/004 039937204 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 25 mg compresse rivestite con film
AT/H/0612/001 039937014 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 25 mg compresse rivestite con film
AT/H/0612/001 039937216 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 25 mg compresse rivestite con film
AT/H/0612/001 039937026 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 25 mg compresse rivestite con film
AT/H/0612/001 039937038 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 25 mg compresse rivestite con film
AT/H/0612/001 039937040 BLUEFISH PHARMACEUTICALS AB
IT
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List of nationally authorised medicinal products EMA/641616/2017 Page 4/221
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
ECURAM 25 mg compresse rivestite con film
AT/H/0612/001 039937053 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 50 mg compresse rivestite con film
AT/H/0612/002 039937065 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 50 mg compresse rivestite con film
AT/H/0612/002 039937077 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 50 mg compresse rivestite con film
AT/H/0612/002 039937089 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 50 mg compresse rivestite con film
AT/H/0612/002 039937091 BLUEFISH PHARMACEUTICALS AB
IT
ECURAM 50 mg compresse rivestite con film
AT/H/0612/002 039937103 BLUEFISH PHARMACEUTICALS AB
IT
Epiramat 100 mg filmom obložene tablete
not available HR-H-575505055 PLIVA HRVATSKA D.O.O. HR
Epiramat 200 mg filmom obložene tablete
not available HR-H-907959213 PLIVA HRVATSKA D.O.O. HR
Epiramat 25 mg filmom obložene tablete
not available HR-H-363242016 PLIVA HRVATSKA D.O.O. HR
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List of nationally authorised medicinal products EMA/641616/2017 Page 5/221
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
Epiramat 50 mg filmom obložene tablete
not available HR-H-856634477 PLIVA HRVATSKA D.O.O. HR
Epiramat, 100 mg, tabletki powlekane
not available 12581 TEVA PHARMACEUTICALS POLSKA SP. Z O.O.
PL
Epiramat, 200 mg, tabletki powlekane
not available 12583 TEVA PHARMACEUTICALS POLSKA SP. Z O.O.
PL
Epiramat, 25 mg, tabletki powlekane
not available 12582 TEVA PHARMACEUTICALS POLSKA SP. Z O.O.
PL
Epiramat, 50 mg, tabletki powlekane
not available 12580 TEVA PHARMACEUTICALS POLSKA SP. Z O.O.
PL
EPITOMAX 100 mg, comprimé pelliculé
SE/H/0110/003 342 647-8 JANSSEN-CILAG FR
EPITOMAX 100 mg, comprimé pelliculé
SE/H/0110/003 342 645-5 JANSSEN-CILAG FR
EPITOMAX 100 mg, comprimé pelliculé
SE/H/0110/003 356 345-9 JANSSEN-CILAG FR
EPITOMAX 100 mg, comprimé pelliculé
SE/H/0110/003 342 648-4 JANSSEN-CILAG FR
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List of nationally authorised medicinal products EMA/641616/2017 Page 6/221
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
EPITOMAX 100 mg, comprimé pelliculé
SE/H/0110/003 342 646-1 JANSSEN-CILAG FR
EPITOMAX 100 mg, comprimé pelliculé
SE/H/0110/003 356 344-2 JANSSEN-CILAG FR
EPITOMAX 15 mg, gélule SE/H/0110/007 348 109-8 JANSSEN-CILAG FR
EPITOMAX 15 mg, gélule SE/H/0110/007 348 305-1 JANSSEN-CILAG FR
EPITOMAX 200 mg, comprimé pelliculé
SE/H/0110/004 341 148-8 JANSSEN-CILAG FR
EPITOMAX 200 mg, comprimé pelliculé
SE/H/0110/004 341 149-4 JANSSEN-CILAG FR
EPITOMAX 200 mg, comprimé pelliculé
SE/H/0110/004 341 227-5 JANSSEN-CILAG FR
EPITOMAX 200 mg, comprimé pelliculé
SE/H/0110/004 356 347-1 JANSSEN-CILAG FR
EPITOMAX 200 mg, comprimé pelliculé
SE/H/0110/004 341 226-9 JANSSEN-CILAG FR
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List of nationally authorised medicinal products EMA/641616/2017 Page 7/221
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
EPITOMAX 200 mg, comprimé pelliculé
SE/H/0110/004 356 346-5 JANSSEN-CILAG FR
EPITOMAX 25 mg, gélule SE/H/0110/008 348 110-6 JANSSEN-CILAG FR
EPITOMAX 25 mg, gélule SE/H/0110/008 348 306-8 JANSSEN-CILAG FR
EPITOMAX 50 mg, comprimé pelliculé
SE/H/0110/002 341 147-1 JANSSEN-CILAG FR
EPITOMAX 50 mg, comprimé pelliculé
SE/H/0110/002 356 343-6 JANSSEN-CILAG FR
EPITOMAX 50 mg, comprimé pelliculé
SE/H/0110/002 341 146-5 JANSSEN-CILAG FR
EPITOMAX 50 mg, comprimé pelliculé
SE/H/0110/002 341 224-6 JANSSEN-CILAG FR
EPITOMAX 50 mg, comprimé pelliculé
SE/H/0110/002 341 225-2 JANSSEN-CILAG FR
EPITOMAX 50 mg, comprimé pelliculé
SE/H/0110/002 356 341-3 JANSSEN-CILAG FR
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List of nationally authorised medicinal products EMA/641616/2017 Page 8/221
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
EPITOMAX 50 mg, gélule SE/H/0110/009 348 111-2 JANSSEN-CILAG FR
EPITOMAX 50 mg, gélule SE/H/0110/009 348 307-4 JANSSEN-CILAG FR
Epitoram, 100 mg, tabletki powlekane
NL/H/1231/003 14665 APOTEX EUROPE B.V. PL
Epitoram, 200 mg, tabletki powlekane
NL/H/1231/004 14664 APOTEX EUROPE B.V. PL
Epitoram, 25 mg, tabletki powlekane
NL/H/1231/001 14667 APOTEX EUROPE B.V. PL
Epitoram, 50 mg, tabletki powlekane
NL/H/1231/002 14666 APOTEX EUROPE B.V. PL
Erravia 100 mg filmom obalené tablety
DK/H/0930/003 21/0512/08-S PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SK
Erravia 200 mg filmom obalené tablety
DK/H/0930/004 21/0513/08-S PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SK
Erravia 25 mg filmom obalené tablety
DK/H/0930/001 21/0510/08-S PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SK
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List of nationally authorised medicinal products EMA/641616/2017 Page 9/221
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
Erravia 50 mg filmom obalené tablety
DK/H/0930/002 21/0511/08-S PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
SK
Etopro 100 mg filmtabletta
DK/H/0930/003 OGYI-T- 20648/05 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Etopro 100 mg filmtabletta
DK/H/0930/003 OGYI-T- 20648/06 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Etopro 200 mg filmtabletta
DK/H/0930/004 OGYI-T- 20648/08 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Etopro 200 mg filmtabletta
DK/H/0930/004 OGYI-T- 20648/07 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Etopro 25 mg filmtabletta DK/H/0930/001 OGYI-T- 20648/01 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Etopro 25 mg filmtabletta DK/H/0930/001 OGYI-T- 20648/02 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Etopro 50 mg filmtabletta DK/H/0930/002 OGYI-T- 20648/03 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
Etopro 50 mg filmtabletta DK/H/0930/002 OGYI-T- 20648/04 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
HU
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List of nationally authorised medicinal products EMA/641616/2017 Page 10/221
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
Etopro, 100 mg, tabletki powlekane
DK/H/0930/003 12895 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
PL
Etopro, 200 mg, tabletki powlekane
DK/H/0930/004 12896 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
PL
Etopro, 25 mg, tabletki powlekane
DK/H/0930/001 12893 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
PL
Etopro, 50 mg, tabletki powlekane
DK/H/0930/002 12894 PHARMASWISS ČESKÁ REPUBLIKA S.R.O.
PL
FAGODOL 25 mg comprimidos recubiertos con pelicula EFG
not available 69001 ARAFARMA GROUP, S.A ES
FAGODOL 25 mg comprimidos recubiertos con pelicula EFG
not available 69001 ARAFARMA GROUP, S.A ES
FAGODOL100 mg comprimidos recubiertos con película EFG
not available 69003 ARAFARMA GROUP, S.A ES
FAGODOL100 mg comprimidos recubiertos con película EFG
not available 69003 ARAFARMA GROUP, S.A ES
FAGODOL200 mg comprimidos recubiertos con película EFG
not available 69004 ARAFARMA GROUP, S.A ES
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List of nationally authorised medicinal products EMA/641616/2017 Page 11/221
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
FAGODOL200 mg comprimidos recubiertos con película EFG
not available 69004 ARAFARMA GROUP, S.A ES
FAGODOL50 mg comprimidos recubiertos con película EFG
not available 69002 ARAFARMA GROUP, S.A ES
FAGODOL50 mg comprimidos recubiertos con película EFG
not available 69002 ARAFARMA GROUP, S.A ES
JADIX® 100mg Επικαλυμμένα με λεπτό υμένιο δισκία
PT/H/0199/003 89042/ 28-12-2010 PHARMAZAC SA GR
JADIX® 200mg Επικαλυμμένα με λεπτό υμένιο δισκία
PT/H/0199/004 89043/ 28-12-2010 PHARMAZAC SA GR
JADIX® 25mg Επικαλυμμένα με λεπτό υμένιο δισκία
PT/H/0199/001 50711/ 29-12-2010 PHARMAZAC SA GR
JADIX® 50mg Επικαλυμμένα με λεπτό υμένιο δισκία
PT/H/0199/002 89039/ 28-12-2010 PHARMAZAC SA GR
LUSITRAX 100 mg film-coated tablets
PT/H/0198/003 6591/2014/01-03 ROMASTRU TRADING SRL RO
LUSITRAX 200 mg film-coated tablets
PT/H/0198/004 6592/2014/01-03 ROMASTRU TRADING SRL RO
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List of nationally authorised medicinal products EMA/641616/2017 Page 12/221
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
LUSITRAX 25 mg film-coated tablets
PT/H/0198/001 6589/2014/01-03 ROMASTRU TRADING SRL RO
LUSITRAX 50 mg film-coated tablets
PT/H/0198/002 6590/2014/01-03 ROMASTRU TRADING SRL RO
Maritop, filmovertrukne tabletter
DK/H/1354/001 41827 G.L. PHARMA GMBH DK
Maritop, filmovertrukne tabletter
DK/H/1354/002 41828 G.L. PHARMA GMBH DK
Maritop, filmovertrukne tabletter
DK/H/1354/003 41829 G.L. PHARMA GMBH DK
Maritop, filmovertrukne tabletter
DK/H/1354/004 41830 G.L. PHARMA GMBH DK
Oritop, 100 mg, tabletki powlekane
FI/H/0800/003 15634 ORION CORPORATION PL
Oritop, 25 mg, tabletki powlekane
FI/H/0800/001 15632 ORION CORPORATION PL
Oritop, 50 mg, tabletki powlekane
FI/H/0800/002 15633 ORION CORPORATION PL
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List of nationally authorised medicinal products EMA/641616/2017 Page 13/221
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
Piraleps 100 mg Film-coated tablets
not available ML 21350 DELORBIS PHARMACEUTICALS LTD
CY
Piraleps 200 mg Film-coated tablets
not available ML 21351 DELORBIS PHARMACEUTICALS LTD
CY
Piraleps 25 mg Film-coated tablets
not available ML 21348 DELORBIS PHARMACEUTICALS LTD
CY
Piraleps 50 mg Film-coated tablets
not available ML 21349 DELORBIS PHARMACEUTICALS LTD
CY
Pirantal 100 mg επικαλυμμένα με λεπτό υμένιο δισκία
DK/H/1355/003 59454_26-07-2016 PHARMANEL COMMERCIAL PHARMACEUTICAL S.A.
GR
Pirantal 200 mg επικαλυμμένα με λεπτό υμένιο δισκία
DK/H/1355/004 59455_26-07-2016 PHARMANEL COMMERCIAL PHARMACEUTICAL S.A.
GR
Pirantal 25 mg επικαλυμμένα με λεπτό υμένιο δισκία
DK/H/1355/001 59452_26-07-2016 PHARMANEL COMMERCIAL PHARMACEUTICAL S.A.
GR
Pirantal 50 mg επικαλυμμένα με λεπτό υμένιο δισκία
DK/H/1355/002 59453_26-07-2016 PHARMANEL COMMERCIAL PHARMACEUTICAL S.A.
GR
Pirepil 100 mg comprimidos revestidos por película
not available 5138821 DECOMED FARMACÊUTICA, S.A.
PT
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List of nationally authorised medicinal products EMA/641616/2017 Page 14/221
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
Pirepil 100 mg comprimidos revestidos por película
not available 5138839 DECOMED FARMACÊUTICA, S.A.
PT
Pirepil 100 mg comprimidos revestidos por película
not available 5138847 DECOMED FARMACÊUTICA, S.A.
PT
Pirepil 100 mg comprimidos revestidos por película
not available 5138813 DECOMED FARMACÊUTICA, S.A.
PT
Pirepil 200 mg comprimidos revestidos por película
not available 5138862 DECOMED FARMACÊUTICA, S.A.
PT
Pirepil 200 mg comprimidos revestidos por película
not available 5138870 DECOMED FARMACÊUTICA, S.A.
PT
Pirepil 200 mg comprimidos revestidos por película
not available 5138904 DECOMED FARMACÊUTICA, S.A.
PT
Pirepil 200 mg comprimidos revestidos por película
not available 5138854 DECOMED FARMACÊUTICA, S.A.
PT
Pirepil 25 mg comprimidos revestidos por película
not available 5138722 DECOMED FARMACÊUTICA, S.A.
PT
Pirepil 25 mg comprimidos revestidos por película
not available 5138730 DECOMED FARMACÊUTICA, S.A.
PT
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List of nationally authorised medicinal products EMA/641616/2017 Page 15/221
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
Pirepil 25 mg comprimidos revestidos por película
not available 5138748 DECOMED FARMACÊUTICA, S.A.
PT
Pirepil 25 mg comprimidos revestidos por película
not available 5138714 DECOMED FARMACÊUTICA, S.A.
PT
Pirepil 50 mg comprimidos revestidos por película
not available 5138763 DECOMED FARMACÊUTICA, S.A.
PT
Pirepil 50 mg comprimidos revestidos por película
not available 5138771 DECOMED FARMACÊUTICA, S.A.
PT
Pirepil 50 mg comprimidos revestidos por película
not available 5138805 DECOMED FARMACÊUTICA, S.A.
PT
Pirepil 50 mg comprimidos revestidos por película
not available 5138755 DECOMED FARMACÊUTICA, S.A.
PT
Ramas 100 mg compresse rivestite con film
FI/H/0599/003 037707205 SANDOZ S.P.A. IT
Ramas 100 mg compresse rivestite con film
FI/H/0599/003 037707229 SANDOZ S.P.A. IT
Ramas 100 mg compresse rivestite con film
FI/H/0599/003 037707395 SANDOZ S.P.A. IT
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List of nationally authorised medicinal products EMA/641616/2017 Page 16/221
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
Ramas 100 mg compresse rivestite con film
FI/H/0599/003 037707559 SANDOZ S.P.A. IT
Ramas 100 mg compresse rivestite con film
FI/H/0599/003 037707585 SANDOZ S.P.A. IT
Ramas 100 mg compresse rivestite con film
FI/H/0599/003 037707217 SANDOZ S.P.A. IT
Ramas 100 mg compresse rivestite con film
FI/H/0599/003 037707193 SANDOZ S.P.A. IT
Ramas 100 mg compresse rivestite con film
FI/H/0599/003 037707231 SANDOZ S.P.A. IT
Ramas 100 mg compresse rivestite con film
FI/H/0599/003 037707546 SANDOZ S.P.A. IT
Ramas 100 mg compresse rivestite con film
FI/H/0599/003 037707561 SANDOZ S.P.A. IT
Ramas 100 mg compresse rivestite con film
FI/H/0599/003 037707573 SANDOZ S.P.A. IT
Ramas 100 mg compresse rivestite con film
FI/H/0599/003 037707534 SANDOZ S.P.A. IT
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List of nationally authorised medicinal products EMA/641616/2017 Page 17/221
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
Ramas 200 mg compresse rivestite con film
FI/H/0599/004 037707623 SANDOZ S.P.A. IT
Ramas 200 mg compresse rivestite con film
FI/H/0599/004 037707282 SANDOZ S.P.A. IT
Ramas 200 mg compresse rivestite con film
FI/H/0599/004 037707294 SANDOZ S.P.A. IT
Ramas 200 mg compresse rivestite con film
FI/H/0599/004 037707306 SANDOZ S.P.A. IT
Ramas 200 mg compresse rivestite con film
FI/H/0599/004 037707320 SANDOZ S.P.A. IT
Ramas 200 mg compresse rivestite con film
FI/H/0599/004 037707407 SANDOZ S.P.A. IT
Ramas 200 mg compresse rivestite con film
FI/H/0599/004 037707597 SANDOZ S.P.A. IT
Ramas 200 mg compresse rivestite con film
FI/H/0599/004 037707611 SANDOZ S.P.A. IT
Ramas 200 mg compresse rivestite con film
FI/H/0599/004 037707318 SANDOZ S.P.A. IT
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List of nationally authorised medicinal products EMA/641616/2017 Page 18/221
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
Ramas 200 mg compresse rivestite con film
FI/H/0599/004 037707609 SANDOZ S.P.A. IT
Ramas 200 mg compresse rivestite con film
FI/H/0599/004 037707635 SANDOZ S.P.A. IT
Ramas 200 mg compresse rivestite con film
FI/H/0599/004 037707647 SANDOZ S.P.A. IT
Ramas 25 mg compresse rivestite con film
FI/H/0599/001 037707054 SANDOZ S.P.A. IT
Ramas 25 mg compresse rivestite con film
FI/H/0599/001 037707371 SANDOZ S.P.A. IT
Ramas 25 mg compresse rivestite con film
FI/H/0599/001 037707421 SANDOZ S.P.A. IT
Ramas 25 mg compresse rivestite con film
FI/H/0599/001 037707433 SANDOZ S.P.A. IT
Ramas 25 mg compresse rivestite con film
FI/H/0599/001 037707027 SANDOZ S.P.A. IT
Ramas 25 mg compresse rivestite con film
FI/H/0599/001 037707039 SANDOZ S.P.A. IT
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List of nationally authorised medicinal products EMA/641616/2017 Page 19/221
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
Ramas 25 mg compresse rivestite con film
FI/H/0599/001 037707460 SANDOZ S.P.A. IT
Ramas 25 mg compresse rivestite con film
FI/H/0599/001 037707041 SANDOZ S.P.A. IT
Ramas 25 mg compresse rivestite con film
FI/H/0599/001 037707015 SANDOZ S.P.A. IT
Ramas 25 mg compresse rivestite con film
FI/H/0599/001 037707419 SANDOZ S.P.A. IT
Ramas 25 mg compresse rivestite con film
FI/H/0599/001 037707445 SANDOZ S.P.A. IT
Ramas 25 mg compresse rivestite con film
FI/H/0599/001 037707458 SANDOZ S.P.A. IT
Ramas 50 mg compresse rivestite con film
FI/H/0599/002 037707104 SANDOZ S.P.A. IT
Ramas 50 mg compresse rivestite con film
FI/H/0599/002 037707130 SANDOZ S.P.A. IT
Ramas 50 mg compresse rivestite con film
FI/H/0599/002 037707508 SANDOZ S.P.A. IT
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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
Ramas 50 mg compresse rivestite con film
FI/H/0599/002 037707116 SANDOZ S.P.A. IT
Ramas 50 mg compresse rivestite con film
FI/H/0599/002 037707142 SANDOZ S.P.A. IT
Ramas 50 mg compresse rivestite con film
FI/H/0599/002 037707472 SANDOZ S.P.A. IT
Ramas 50 mg compresse rivestite con film
FI/H/0599/002 037707510 SANDOZ S.P.A. IT
Ramas 50 mg compresse rivestite con film
FI/H/0599/002 037707522 SANDOZ S.P.A. IT
Ramas 50 mg compresse rivestite con film
FI/H/0599/002 037707128 SANDOZ S.P.A. IT
Ramas 50 mg compresse rivestite con film
FI/H/0599/002 037707496 SANDOZ S.P.A. IT
Ramas 50 mg compresse rivestite con film
FI/H/0599/002 037707484 SANDOZ S.P.A. IT
Ramas 50 mg compresse rivestite con film
FI/H/0599/002 037707383 SANDOZ S.P.A. IT
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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
SINCRONIL 100 mg compresse rivestite con film
DK/H/1355/003 039469085 FIDIA FARMACEUTICI S.P.A IT
SINCRONIL 100 mg compresse rivestite con film
DK/H/1355/003 039469097 FIDIA FARMACEUTICI S.P.A IT
SINCRONIL 100 mg compresse rivestite con film
DK/H/1355/001-004/MR
039469073 FIDIA FARMACEUTICI S.P.A IT
SINCRONIL 200 mg compresse rivestite con film
DK/H/1355/004 039469111 FIDIA FARMACEUTICI S.P.A IT
SINCRONIL 200 mg compresse rivestite con film
DK/H/1355/004 039469123 FIDIA FARMACEUTICI S.P.A IT
SINCRONIL 200 mg compresse rivestite con film
DK/H/1355/001-004/MR
039469109 FIDIA FARMACEUTICI S.P.A IT
SINCRONIL 25 mg compresse rivestite con film
DK/H/1355/001 039469022 FIDIA FARMACEUTICI S.P.A IT
SINCRONIL 25 mg compresse rivestite con film
DK/H/1355/001 039469034 FIDIA FARMACEUTICI S.P.A IT
SINCRONIL 25 mg compresse rivestite con film
DK/H/1355/001-004/MR
039469010 FIDIA FARMACEUTICI S.P.A IT
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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
SINCRONIL 50 mg compresse rivestite con film
DK/H/1355/002 039469059 FIDIA FARMACEUTICI S.P.A IT
SINCRONIL 50 mg compresse rivestite con film
DK/H/1355/002 039469061 FIDIA FARMACEUTICI S.P.A IT
SINCRONIL 50 mg compresse rivestite con film
DK/H/1355/001-004/MR
039469046 FIDIA FARMACEUTICI S.P.A IT
Talopam 100 mg film-coated tablets
PT/H/0231/003 MA628/06803 ACTAVIS GROUP PTC EHF. MT
Talopam 100 mg filmom obalené tablety
PT/H/0231/003 21/0757/09-S ACTAVIS GROUP PTC EHF. SK
Talopam 200 mg film-coated tablets
PT/H/0231/004 MA628/06804 ACTAVIS GROUP PTC EHF. MT
Talopam 25 mg film-coated tablets
PT/H/0231/001 MA628/06801 ACTAVIS GROUP PTC EHF. MT
Talopam 25 mg filmom obalené tablety
PT/H/0231/001 21/0755/09-S ACTAVIS GROUP PTC EHF. SK
Talopam 50 mg film-coated tablets
PT/H/0231/002 MA628/06802 ACTAVIS GROUP PTC EHF. MT
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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
Talopam 50 mg filmom obalené tablety
PT/H/0231/002 21/0756/09-S ACTAVIS GROUP PTC EHF. SK
TIRAMAT 100 mg filmom obložene tablete
not available UP/I-530-09/12-02/194 BELUPO D.D. HR
TIRAMAT 25 mg filmom obložene tablete
not available UP/I-530-09/12-02/192 BELUPO D.D. HR
TIRAMAT 50 mg filmom obložene tablete
not available UP/I-530-09/12-02/193 BELUPO D.D. HR
Topaben 100 mg filmovertrukne tabletter
DK/H/1355/003 41833 PHARMATHEN S.A. DK
Topaben 100 mg filmovertrukne tabletter
DK/H/1355/003 41833 PHARMATHEN S.A. DK
Topaben 200 mg filmovertrukne tabletter
DK/H/1355/004 41834 PHARMATHEN S.A. DK
Topaben 200 mg filmovertrukne tabletter
DK/H/1355/004 41834 PHARMATHEN S.A. DK
Topaben 25 mg filmovertrukne tabletter
DK/H/1355/001 41831 PHARMATHEN S.A. DK
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List of nationally authorised medicinal products EMA/641616/2017 Page 24/221
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
Topaben 25 mg filmovertrukne tabletter
DK/H/1355/001 41831 PHARMATHEN S.A. DK
Topaben 50 mg filmovertrukne tabletter
DK/H/1355/002 41832 PHARMATHEN S.A. DK
Topaben 50 mg filmovertrukne tabletter
DK/H/1355/002 41832 PHARMATHEN S.A. DK
Topamac 100 mg επικαλυμμένα με λεπτό υμένιο δισκία
SE/H/0110/003 36170/26.05.2015 JANSSEN-CILAG PHARMACEUTICAL S.A.C.I.
GR
Topamac 15 mg καψάκια, σκληρά
SE/H/0110/007 36172/26.05.2015 JANSSEN-CILAG PHARMACEUTICAL S.A.C.I.
GR
Topamac 200 mg επικαλυμμένα με λεπτό υμένιο δισκία
SE/H/0110/004 36179/26.05.2015 JANSSEN-CILAG PHARMACEUTICAL S.A.C.I.
GR
Topamac 25 mg επικαλυμμένα με λεπτό υμένιο δισκία
SE/H/0110/001 36176/26.05.2015 JANSSEN-CILAG PHARMACEUTICAL S.A.C.I.
GR
Topamac 25 mg καψάκια, σκληρά
SE/H/0110/008 36173/26.05.2015 JANSSEN-CILAG PHARMACEUTICAL S.A.C.I.
GR
Topamac 50 mg επικαλυμμένα με λεπτό υμένιο δισκία
SE/H/0110/002 36178/26.05.2015 JANSSEN-CILAG PHARMACEUTICAL S.A.C.I.
GR
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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
Topamac 50 mg καψάκια, σκληρά
SE/H/0110/009 36175/26.05.2015 JANSSEN-CILAG PHARMACEUTICAL S.A.C.I.
GR
TOPAMAX SE/H/0110/007 018/00305 JANSSEN-CILAG INTERNATIONAL NV
MT
TOPAMAX SE/H/0110/009 018/00307 JANSSEN-CILAG INTERNATIONAL NV
MT
TOPAMAX SE/H/0110/003 018/00303 JANSSEN-CILAG INTERNATIONAL NV
MT
TOPAMAX SE/H/0110/008 018/00306 JANSSEN-CILAG INTERNATIONAL NV
MT
TOPAMAX SE/H/0110/001 018/00301 JANSSEN-CILAG INTERNATIONAL NV
MT
TOPAMAX SE/H/0110/004 018/00304 JANSSEN-CILAG INTERNATIONAL NV
MT
TOPAMAX SE/H/0110/002 018/00302 JANSSEN-CILAG INTERNATIONAL NV
MT
Topamax 100 SE/H/0110/003 21/0121/11-S JOHNSON & JOHNSON, S.R.O SK
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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
Topamax 100 mg apvalkotās tabletes
SE/H/0110/003 00-0122 UAB JOHNSON & JOHNSON LV
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023552 JANSSEN-CILAG SPA IT
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023285 JANSSEN-CILAG SPA IT
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023261 JANSSEN-CILAG SPA IT
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023741 JANSSEN-CILAG SPA IT
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023549 JANSSEN-CILAG SPA IT
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023828 JANSSEN-CILAG SPA IT
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023273 JANSSEN-CILAG SPA IT
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023501 JANSSEN-CILAG SPA IT
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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
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023537 JANSSEN-CILAG SPA IT
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023246 JANSSEN-CILAG SPA IT
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023499 JANSSEN-CILAG SPA IT
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023525 JANSSEN-CILAG SPA IT
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023780 JANSSEN-CILAG SPA IT
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023513 JANSSEN-CILAG SPA IT
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023259 JANSSEN-CILAG SPA IT
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023234 JANSSEN-CILAG SPA IT
Topamax 100 mg compresse rivestite con film
SE/H/0110/003 032023032 JANSSEN-CILAG SPA IT
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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
Topamax 100 mg comprimate filmate
SE/H/0110/003 4506/2012/01-17 JOHNSON & JOHNSON PRODAJA MEDICINSKIH IN FARMACEVTSKIH IZDELKOV, D.O.O.
RO
Topamax 100 mg comprimés pelliculés
SE/H/0110/003 1997120543 JANSSEN-CILAG NV LU
Topamax 100 mg comprimés pelliculés
SE/H/0110/003 0162/97/12/0543 JANSSEN-CILAG NV LU
Topamax 100 mg comprimidos recubiertos con película
SE/H/0110/003 61.875 JANSSEN-CILAG S.A. ES
Topamax 100 mg comprimidos revestidos por película
SE/H/0110/003 3481298 JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
Topamax 100 mg comprimidos revestidos por película
SE/H/0110/003 5320197 JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
Topamax 100 mg comprimidos revestidos por película
SE/H/0110/003 3481199 JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
Topamax 100 mg film-coated tablets
SE/H/0110/003 PA 0748/012/003 JANSSEN-CILAG LIMITED IE
Topamax 100 mg filmom obložene tablete
not available HR-H-839682871 JOHNSON & JOHNSON S.E. D.O.O.
HR
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List of nationally authorised medicinal products EMA/641616/2017 Page 29/221
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
Topamax 100 mg filmomhulde tabletten
SE/H/0110/003 BE184371 JANSSEN-CILAG NV BE
Topamax 100 mg filmomhulde tabletten
SE/H/0110/003 BE398596 JANSSEN-CILAG NV BE
Topamax 100 mg filmtabletta
SE/H/0110/003 OGYI-T-6268/08 JANSSEN-CILAG KFT. HU
Topamax 100 mg filmtabletta
SE/H/0110/003 OGYI-T-6268/07 JANSSEN-CILAG KFT. HU
Topamax 100 mg Filmtabletten
SE/H/0110/003 1-22142 JANSSEN-CILAG PHARMA GMBH
AT
Topamax 100 mg Filmtabletten
SE/H/0110/003 35027.02.00 JANSSEN-CILAG GMBH DE
Topamax 100 mg plėvele dengtos tabletės
SE/H/0110/003 LT/1/98/0093/003 UAB JOHNSON & JOHNSON LT
Topamax 100 mg επικαλυμμένα με λεπτό υμένιο δισκία
SE/H/0110/003 18275 JANSSEN-CILAG INTERNATIONAL NV
CY
Topamax 100 mg potahované tablety
SE/H/0110/003 21/512/97-C JANSSEN-CILAG S.R.O CZ
-
List of nationally authorised medicinal products EMA/641616/2017 Page 30/221
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
Topamax 100 mg, filmomhulde tabletten
SE/H/0110/003 RVG 24167 JANSSEN-CILAG BV NL
Topamax 15 mg cápsulas SE/H/0110/007 3221595 JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
Topamax 15 mg cápsulas SE/H/0110/007 3221496 JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
Topamax 15 mg capsule rigide
SE/H/0110/007 032023640 JANSSEN-CILAG SPA IT
Topamax 15 mg capsule rigide
SE/H/0110/007 032023638 JANSSEN-CILAG SPA IT
Topamax 15 mg capsule rigide
SE/H/0110/007 032023653 JANSSEN-CILAG SPA IT
Topamax 15 mg capsule rigide
SE/H/0110/007 032023083 JANSSEN-CILAG SPA IT
Topamax 15 mg gélules SE/H/0110/007 0162/00/01/0043 JANSSEN-CILAG NV LU
Topamax 15 mg Granulat in Kapseln
SE/H/0110/007 1-23233 JANSSEN-CILAG PHARMA GMBH
AT
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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
Topamax 15 mg harde capsules
SE/H/0110/007 BE207426 JANSSEN-CILAG NV BE
Topamax 15 mg καψάκια, σκληρά
SE/H/0110/007 19558 JANSSEN-CILAG INTERNATIONAL NV
CY
Topamax 15 mg, tvrdé tobolky
SE/H/0110/007 21/653/99-C JANSSEN-CILAG S.R.O CZ
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023311 JANSSEN-CILAG SPA IT
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023335 JANSSEN-CILAG SPA IT
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023754 JANSSEN-CILAG SPA IT
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023626 JANSSEN-CILAG SPA IT
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023588 JANSSEN-CILAG SPA IT
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023576 JANSSEN-CILAG SPA IT
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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
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023297 JANSSEN-CILAG SPA IT
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023830 JANSSEN-CILAG SPA IT
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023347 JANSSEN-CILAG SPA IT
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023614 JANSSEN-CILAG SPA IT
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023792 JANSSEN-CILAG SPA IT
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023590 JANSSEN-CILAG SPA IT
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023309 JANSSEN-CILAG SPA IT
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023323 JANSSEN-CILAG SPA IT
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023602 JANSSEN-CILAG SPA IT
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List of nationally authorised medicinal products EMA/641616/2017 Page 33/221
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
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023564 JANSSEN-CILAG SPA IT
Topamax 200 mg compresse rivestite con film
SE/H/0110/004 032023044 JANSSEN-CILAG SPA IT
Topamax 200 mg comprimés pelliculés
SE/H/0110/004 0162/97/12/0544 JANSSEN-CILAG NV LU
Topamax 200 mg comprimés pelliculés
SE/H/0110/004 1997120544 JANSSEN-CILAG NV LU
Topamax 200 mg comprimidos recubiertos con película
SE/H/0110/004 61.876 JANSSEN-CILAG S.A. ES
Topamax 200 mg comprimidos revestidos por película
SE/H/0110/004 3481496 JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
Topamax 200 mg comprimidos revestidos por película
SE/H/0110/004 3481397 JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
Topamax 200 mg film-coated tablets
SE/H/0110/004 PA 0748/012/004 JANSSEN-CILAG LIMITED IE
Topamax 200 mg filmom obložene tablete
not available HR-H-668959661 JOHNSON & JOHNSON S.E. D.O.O.
HR
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List of nationally authorised medicinal products EMA/641616/2017 Page 34/221
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
Topamax 200 mg filmomhulde tabletten
SE/H/0110/004 BE184362 JANSSEN-CILAG NV BE
Topamax 200 mg filmomhulde tabletten
SE/H/0110/004 BE398605 JANSSEN-CILAG NV BE
Topamax 200 mg filmsko obložene tablete
SE/H/0110/004 H/97/01540/056 JOHNSON & JOHNSON PRODAJA MEDICINSKIH IN FARMACEVTSKIH IZDELKOV, D.O.O.
SI
Topamax 200 mg filmtabletta
SE/H/0110/004 OGYI-T-6268/09 JANSSEN-CILAG KFT. HU
Topamax 200 mg filmtabletta
SE/H/0110/004 OGYI-T-6268/10 JANSSEN-CILAG KFT. HU
Topamax 200 mg Filmtabletten
SE/H/0110/004 1-22143 JANSSEN-CILAG PHARMA GMBH
AT
Topamax 200 mg Filmtabletten
SE/H/0110/004 35027.03.00 JANSSEN-CILAG GMBH DE
Topamax 200 mg plėvele dengtos tabletės
SE/H/0110/004 LT/1/98/0093/004 UAB JOHNSON & JOHNSON LT
Topamax 200 mg επικαλυμμένα με λεπτό υμένιο δισκία
SE/H/0110/004 18278 JANSSEN-CILAG INTERNATIONAL NV
CY
-
List of nationally authorised medicinal products EMA/641616/2017 Page 35/221
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
Topamax 200 mg, filmomhulde tabletten
SE/H/0110/004 RVG 24168 JANSSEN-CILAG BV NL
Topamax 25 SE/H/0110/001 21/0108/98-S JOHNSON & JOHNSON, S.R.O SK
Topamax 25 mg SE/H/0110/001 21/510/97-C JANSSEN-CILAG S.R.O CZ
Topamax 25 mg SE/H/0110/008 21/654/99-C JANSSEN-CILAG S.R.O CZ
Topamax 25 mg apvalkotās tabletes
SE/H/0110/001 00-0120 UAB JOHNSON & JOHNSON LV
Topamax 25 mg cápsulas SE/H/0110/008 3221694 JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
Topamax 25 mg capsule rigide
SE/H/0110/008 032023677 JANSSEN-CILAG SPA IT
Topamax 25 mg capsule rigide
SE/H/0110/008 032023689 JANSSEN-CILAG SPA IT
Topamax 25 mg capsule rigide
SE/H/0110/008 032023665 JANSSEN-CILAG SPA IT
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List of nationally authorised medicinal products EMA/641616/2017 Page 36/221
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
Topamax 25 mg capsule rigide
SE/H/0110/008 032023095 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023362 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023400 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023133 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023412 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023158 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023727 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023804 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023121 JANSSEN-CILAG SPA IT
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List of nationally authorised medicinal products EMA/641616/2017 Page 37/221
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
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023160 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023386 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023350 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023374 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023766 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023119 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023398 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023145 JANSSEN-CILAG SPA IT
Topamax 25 mg compresse rivestite con film
SE/H/0110/001 032023071 JANSSEN-CILAG SPA IT
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List of nationally authorised medicinal products EMA/641616/2017 Page 38/221
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
Topamax 25 mg comprimate filmate
SE/H/0110/001 4504/2012/01-17 JOHNSON & JOHNSON PRODAJA MEDICINSKIH IN FARMACEVTSKIH IZDELKOV, D.O.O.
RO
Topamax 25 mg comprimés pelliculés
SE/H/0110/001 0162/97/12/0591 JANSSEN-CILAG NV LU
Topamax 25 mg comprimés pelliculés
SE/H/0110/001 1997120591 JANSSEN-CILAG NV LU
Topamax 25 mg comprimidos recubiertos con película
SE/H/0110/001 61.873 JANSSEN-CILAG S.A. ES
Topamax 25 mg comprimidos revestidos por película
SE/H/0110/001 3480894 JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
Topamax 25 mg comprimidos revestidos por película
SE/H/0110/001 3480795 JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
Topamax 25 mg film-coated tablets
SE/H/0110/001 PA 0748/012/001 JANSSEN-CILAG LIMITED IE
Topamax 25 mg filmom obložene tablete
not available HR-H-239773821 JOHNSON & JOHNSON S.E. D.O.O.
HR
Topamax 25 mg filmomhulde tabletten
SE/H/0110/001 BE398571 JANSSEN-CILAG NV BE
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List of nationally authorised medicinal products EMA/641616/2017 Page 39/221
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
Topamax 25 mg filmomhulde tabletten
SE/H/0110/001 BE184405 JANSSEN-CILAG NV BE
Topamax 25 mg filmtabletta
SE/H/0110/001 OGYI-T-6268/03 JANSSEN-CILAG KFT. HU
Topamax 25 mg filmtabletta
SE/H/0110/001 OGYI-T-6268/04 JANSSEN-CILAG KFT. HU
Topamax 25 mg Filmtabletten
SE/H/0110/001 1-22139 JANSSEN-CILAG PHARMA GMBH
AT
Topamax 25 mg Filmtabletten
SE/H/0110/001 35027.00.00 JANSSEN-CILAG GMBH DE
Topamax 25 mg gélules SE/H/0110/008 0162/00/01/0044 JANSSEN-CILAG NV LU
Topamax 25 mg Granulat in Kapseln
SE/H/0110/008 1-23234 JANSSEN-CILAG PHARMA GMBH
AT
Topamax 25 mg harde capsules
SE/H/0110/008 BE207435 JANSSEN-CILAG NV BE
Topamax 25 mg Hartkapseln
SE/H/0110/008 35033.00.00 JANSSEN-CILAG GMBH DE
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List of nationally authorised medicinal products EMA/641616/2017 Page 40/221
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
Topamax 25 mg plėvele dengtos tabletės
SE/H/0110/001 LT/1/98/0093/001 UAB JOHNSON & JOHNSON LT
Topamax 25 mg επικαλυμμένα με λεπτό υμένιο δισκία
SE/H/0110/001 18277 JANSSEN-CILAG INTERNATIONAL NV
CY
Topamax 25 mg καψάκια σκληρά
SE/H/0110/008 19576 JANSSEN-CILAG INTERNATIONAL NV
CY
Topamax 25 mg, filmomhulde tabletten
SE/H/0110/001 RVG 24165 JANSSEN-CILAG BV NL
Topamax 50 SE/H/0110/002 21/0120/11-S JOHNSON & JOHNSON, S.R.O SK
Topamax 50 mg SE/H/0110/002 21/511/97-C JANSSEN-CILAG S.R.O CZ
Topamax 50 mg apvalkotās tabletes
SE/H/0110/002 00-0121 UAB JOHNSON & JOHNSON LV
Topamax 50 mg cápsulas SE/H/0110/009 3221793 JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
Topamax 50 mg capsule rigide
SE/H/0110/009 032023703 JANSSEN-CILAG SPA IT
-
List of nationally authorised medicinal products EMA/641616/2017 Page 41/221
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
Topamax 50 mg capsule rigide
SE/H/0110/009 032023691 JANSSEN-CILAG SPA IT
Topamax 50 mg capsule rigide
SE/H/0110/009 032023715 JANSSEN-CILAG SPA IT
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023222 JANSSEN-CILAG SPA IT
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023196 JANSSEN-CILAG SPA IT
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023816 JANSSEN-CILAG SPA IT
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023463 JANSSEN-CILAG SPA IT
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023739 JANSSEN-CILAG SPA IT
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023487 JANSSEN-CILAG SPA IT
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023448 JANSSEN-CILAG SPA IT
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List of nationally authorised medicinal products EMA/641616/2017 Page 42/221
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
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023451 JANSSEN-CILAG SPA IT
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023475 JANSSEN-CILAG SPA IT
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023208 JANSSEN-CILAG SPA IT
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023778 JANSSEN-CILAG SPA IT
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023210 JANSSEN-CILAG SPA IT
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023184 JANSSEN-CILAG SPA IT
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023172 JANSSEN-CILAG SPA IT
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023424 JANSSEN-CILAG SPA IT
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023436 JANSSEN-CILAG SPA IT
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List of nationally authorised medicinal products EMA/641616/2017 Page 43/221
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
Topamax 50 mg compresse rivestite con film
SE/H/0110/002 032023020 JANSSEN-CILAG SPA IT
Topamax 50 mg comprimate filmate
SE/H/0110/002 4505/2012/01-17 JOHNSON & JOHNSON PRODAJA MEDICINSKIH IN FARMACEVTSKIH IZDELKOV, D.O.O.
RO
Topamax 50 mg comprimés pelliculés
SE/H/0110/002 1997120542 JANSSEN-CILAG NV LU
Topamax 50 mg comprimés pelliculés
SE/H/0110/002 0162/97/12/0542 JANSSEN-CILAG NV LU
Topamax 50 mg comprimidos recubiertos con película
SE/H/0110/002 61.874 JANSSEN-CILAG S.A. ES
Topamax 50 mg comprimidos revestidos por película
SE/H/0110/002 3481090 JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
Topamax 50 mg comprimidos revestidos por película
SE/H/0110/002 3480993 JANSSEN-CILAG FARMACÊUTICA, LDA.
PT
Topamax 50 mg film-coated tablets
SE/H/0110/002 PA 0748/012/002 JANSSEN-CILAG LIMITED IE
Topamax 50 mg filmom obložene tablete
not available HR-H-610277393 JOHNSON & JOHNSON S.E. D.O.O.
HR
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List of nationally authorised medicinal products EMA/641616/2017 Page 44/221
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
Topamax 50 mg filmomhulde tabletten
SE/H/0110/002 BE184387 JANSSEN-CILAG NV BE
Topamax 50 mg filmomhulde tabletten
SE/H/0110/002 BE398587 JANSSEN-CILAG NV BE
Topamax 50 mg filmtabletta
SE/H/0110/002 OGYI-T-6268/06 JANSSEN-CILAG KFT. HU
Topamax 50 mg filmtabletta
SE/H/0110/002 OGYI-T-6268/05 JANSSEN-CILAG KFT. HU
Topamax 50 mg Filmtabletten
SE/H/0110/002 1-22141 JANSSEN-CILAG PHARMA GMBH
AT
Topamax 50 mg Filmtabletten
SE/H/0110/002 35027.01.00 JANSSEN-CILAG GMBH DE
Topamax 50 mg gélules SE/H/0110/009 0162/00/01/0045 JANSSEN-CILAG NV LU
Topamax 50 mg Granulat in Kapseln
SE/H/0110/009 1-23235 JANSSEN-CILAG PHARMA GMBH
AT
Topamax 50 mg harde capsules
SE/H/0110/009 BE207444 JANSSEN-CILAG NV BE
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List of nationally authorised medicinal products EMA/641616/2017 Page 45/221
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
Topamax 50 mg Hartkapseln
SE/H/0110/009 35033.01.00 JANSSEN-CILAG GMBH DE
Topamax 50 mg plėvele dengtos tabletės
SE/H/0110/002 LT/1/98/0093/002 UAB JOHNSON & JOHNSON LT
Topamax 50 mg επικαλυμμένα με λεπτό υμένιο δισκία
SE/H/0110/002 18276 JANSSEN-CILAG INTERNATIONAL NV
CY
Topamax 50 mg καψάκια σκληρά
SE/H/0110/009 19577 JANSSEN-CILAG INTERNATIONAL NV
CY
Topamax dispersable 15 mg cápsulas duras
SE/H/0110/007 63.957 JANSSEN-CILAG S.A. ES
Topamax dispersable 25 mg cápsulas duras
SE/H/0110/008 63.959 JANSSEN-CILAG S.A. ES
Topamax dispersable 50 mg cápsulas duras
SE/H/0110/009 63.960 JANSSEN-CILAG S.A. ES
Topamax Sprinkle 15 mg hard capsules
SE/H/0110/007 PA 0748/012/007 JANSSEN-CILAG LIMITED IE
Topamax Sprinkle 15 mg, harde capsules
SE/H/0110/007 RVG 25836 JANSSEN-CILAG BV NL
-
List of nationally authorised medicinal products EMA/641616/2017 Page 46/221
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
Topamax Sprinkle 25 mg, harde capsules
SE/H/0110/008 RVG 25837 JANSSEN-CILAG BV NL
Topamax Sprinkle 50 mg, harde capsules
SE/H/0110/009 RVG 25838 JANSSEN-CILAG BV NL
TOPAMAX, 100 mg õhukese polümeerikattega tabletid
SE/H/0110/003 314400 UAB JOHNSON & JOHNSON EE
Topamax, 100 mg, tabletki powlekane
SE/H/0110/003 7590 JANSSEN-CILAG INTERNATIONAL NV
PL
Topamax, 15 mg, kapsułki twarde
SE/H/0110/007 8615 JANSSEN-CILAG INTERNATIONAL NV
PL
TOPAMAX, 200 mg õhukese polümeerikattega tabletid
SE/H/0110/004 314100 UAB JOHNSON & JOHNSON EE
Topamax, 200 mg, tabletki powlekane
SE/H/0110/004 7591 JANSSEN-CILAG INTERNATIONAL NV
PL
TOPAMAX, 25 mg õhukese polümeerikattega tabletid
SE/H/0110/001 314500 UAB JOHNSON & JOHNSON EE
Topamax, 25 mg, kapsułki twarde
SE/H/0110/008 8616 JANSSEN-CILAG INTERNATIONAL NV
PL
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List of nationally authorised medicinal products EMA/641616/2017 Page 47/221
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
Topamax, 25 mg, tabletki powlekane
SE/H/0110/001 7588 JANSSEN-CILAG INTERNATIONAL NV
PL
TOPAMAX, 50 mg õhukese polümeerikattega tabletid
SE/H/0110/002 314300 UAB JOHNSON & JOHNSON EE
Topamax, 50 mg, tabletki powlekane
SE/H/0110/002 7589 JANSSEN-CILAG INTERNATIONAL NV
PL
Topamax® 100 mg film-coated tablets
SE/H/0110/003 PL 00242/0303 JANSSEN-CILAG LIMITED UK
Topamax® 200 mg film-coated tablets
SE/H/0110/004 PL 00242/0304 JANSSEN-CILAG LIMITED UK
Topamax® 25 mg film-coated tablets
SE/H/0110/001 PL 00242/0301 JANSSEN-CILAG LIMITED UK
Topamax® 50 mg film-coated tablets
SE/H/0110/002 PL 00242/0302 JANSSEN-CILAG LIMITED UK
Topamax® Sprinkle 15 mg hard capsules
SE/H/0110/007 PL 00242/0348 JANSSEN-CILAG LIMITED UK
Topamax® Sprinkle 25 mg hard capsules
SE/H/0110/008 PA 0748/012/008 JANSSEN-CILAG LIMITED IE
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List of nationally authorised medicinal products EMA/641616/2017 Page 48/221
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
Topamax® Sprinkle 25 mg hard capsules
SE/H/0110/008 PL 00242/0349 JANSSEN-CILAG LIMITED UK
Topamax® Sprinkle 50 mg hard capsules
SE/H/0110/009 PA 0748/012/009 JANSSEN-CILAG LIMITED IE
Topamax® Sprinkle 50 mg hard capsules
SE/H/0110/009 PL 00242/0350 JANSSEN-CILAG LIMITED UK
Topepsil 100 mg filmtabletta
NL/H/0863/003/DC OGYI-T-20604/01-04 EGIS PHARMACEUTICALS PLC
HU
Topepsil 200 mg filmom obalené tablety
NL/H/0864/004/DC 21/0377/07-S EGIS PHARMACEUTICALS PLC
SK
Topepsil 200 mg filmtabletta
NL/H/0863/004/DC OGYI-T-20604/05-08 EGIS PHARMACEUTICALS PLC
HU
Topepsill00 mg filmom obalené tablety
NL/H/0864/003 2 1 /03 76/07-S EGIS PHARMACEUTICALS PLC
SK
TOPIBRAIN 100 mg comprimidos recubiertos con película
not available 68666 FERRER INTERNACIONAL, S.A.
ES
TOPIBRAIN 200 mg comprimidos recubiertos con película
not available 68676 FERRER INTERNACIONAL, S.A.
ES
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List of nationally authorised medicinal products EMA/641616/2017 Page 49/221
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
TOPIBRAIN 25 mg comprimidos recubiertos con película
not available 68664 FERRER INTERNACIONAL, S.A.
ES
TOPIBRAIN 50 mg comprimidos recubiertos con película
not available 68665 FERRER INTERNACIONAL, S.A.
ES
TopiLEK 100, 100 mg, tabletki powlekane
FI/H/0599/003 12684 SANDOZ GMBH PL
TopiLEK 200, 200 mg, tabletki powlekane
FI/H/0599/004 12685 SANDOZ GMBH PL
TopiLEK 25, 25 mg, tabletki powlekane
FI/H/0599/001 12680 SANDOZ GMBH PL
TopiLEK 50, 50 mg, tabletki powlekane
FI/H/0599/002 12683 SANDOZ GMBH PL
Topilept 100 mg filmomhulde tabletten
NL/H/864/003-004/DC RVG 34255 EGIS PHARMACEUTICALS PLC
NL
Topilept 200 mg filmomhulde tabletten
NL/H/864/003-004/DC RVG 34256 EGIS PHARMACEUTICALS PLC
NL
Topilex 100 mg DK/H/1354/003 21/0402/08-S G.L. PHARMA GMBH SK
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List of nationally authorised medicinal products EMA/641616/2017 Page 50/221
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
Topilex 100 mg comprimate filmate
DK/H/1354/003 5531/2013/04 LANNACHER HEILMITTEL GES.M.B.H.,
RO
Topilex 100 mg comprimate filmate
DK/H/1354/003 5531/2013/01 LANNACHER HEILMITTEL GES.M.B.H.,
RO
Topilex 100 mg comprimate filmate
DK/H/1354/003 5531/2013/02 LANNACHER HEILMITTEL GES.M.B.H.,
RO
Topilex 100 mg comprimate filmate
DK/H/1354/003 5531/2013/03 LANNACHER HEILMITTEL GES.M.B.H.,
RO
Topilex 100 mg potahované tablety
DK/H/1354/003 21/456/08-C G.L. PHARMA GMBH CZ
Topilex 100 mg-Filmtabletten
DK/H/1354/003 1–27686 G.L. PHARMA GMBH AT
Topilex 200 mg DK/H/1354/004 21/0403/08-S G.L. PHARMA GMBH SK
Topilex 200 mg comprimate filmate
DK/H/1354/004 5532/2013/04 LANNACHER HEILMITTEL GES.M.B.H.,
RO
Topilex 200 mg comprimate filmate
DK/H/1354/004 5532/2013/01 LANNACHER HEILMITTEL GES.M.B.H.,
RO
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List of nationally authorised medicinal products EMA/641616/2017 Page 51/221
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
Topilex 200 mg comprimate filmate
DK/H/1354/004 5532/2013/02 LANNACHER HEILMITTEL GES.M.B.H.,
RO
Topilex 200 mg comprimate filmate
DK/H/1354/004 5532/2013/03 LANNACHER HEILMITTEL GES.M.B.H.,
RO
Topilex 200 mg-Filmtabletten
DK/H/1354/004 1–27687 G.L. PHARMA GMBH AT
Topilex 25 mg DK/H/1354/001 21/0400/08-S G.L. PHARMA GMBH SK
Topilex 25 mg comprimate filmate
DK/H/1354/001 5529/2013/04 LANNACHER HEILMITTEL GES.M.B.H.,
RO
Topilex 25 mg comprimate filmate
DK/H/1354/001 5529/2013/01 LANNACHER HEILMITTEL GES.M.B.H.,
RO
Topilex 25 mg comprimate filmate
DK/H/1354/001 5529/2013/02 LANNACHER HEILMITTEL GES.M.B.H.,
RO
Topilex 25 mg comprimate filmate
DK/H/1354/001 5529/2013/03 LANNACHER HEILMITTEL GES.M.B.H.,
RO
Topilex 25 mg potahované tablety
DK/H/1354/001 21/454/08-C G.L. PHARMA GMBH CZ
-
List of nationally authorised medicinal products EMA/641616/2017 Page 52/221
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
Topilex 25 mg-Filmtabletten
DK/H/1354/001 1–27684 G.L. PHARMA GMBH AT
Topilex 50 mg DK/H/1354/002 21/0401/08-S G.L. PHARMA GMBH SK
Topilex 50 mg comprimate filmate
DK/H/1354/002 5530/2013/04 LANNACHER HEILMITTEL GES.M.B.H.,
RO
Topilex 50 mg comprimate filmate
DK/H/1354/002 5530/2013/01 LANNACHER HEILMITTEL GES.M.B.H.,
RO
Topilex 50 mg comprimate filmate
DK/H/1354/002 5530/2013/02 LANNACHER HEILMITTEL GES.M.B.H.,
RO
Topilex 50 mg comprimate filmate
DK/H/1354/002 5530/2013/03 LANNACHER HEILMITTEL GES.M.B.H.,
RO
Topilex 50 mg potahované tablety
DK/H/1354/002 21/455/08-C G.L. PHARMA GMBH CZ
Topilex 50 mg-Filmtabletten
DK/H/1354/002 1–27685 G.L. PHARMA GMBH AT
Topimark 100 mg filmom obalené tablety
DE/H/0984/003 21/0187/08-S GLENMARK PHARMACEUTICALS S.R.O.
SK
-
List of nationally authorised medicinal products EMA/641616/2017 Page 53/221
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
Topimark 100 mg potahované tablety
DE/H/0984/003 21/245/08-C GLENMARK PHARMACEUTICALS S.R.O.
CZ
Topimark 200 mg filmom obalené tablety
DE/H/0984/004 21/0188/08-S GLENMARK PHARMACEUTICALS S.R.O.
SK
Topimark 25 mg filmom obalené tablety
DE/H/0984/001 21/0185/08-S GLENMARK PHARMACEUTICALS S.R.O.
SK
Topimark 25 mg potahované tablety
DE/H/0984/001 21/243/08-C GLENMARK PHARMACEUTICALS S.R.O.
CZ
Topimark 50 mg filmom obalené tablety
DE/H/0984/002 21/0186/08-S GLENMARK PHARMACEUTICALS S.R.O.
SK
TOPIMARK 50 MG POTAHOVANÉ TABLETY
DE/H/0984/002 21/244/08-C GLENMARK PHARMACEUTICALS S.R.O.
CZ
Topimax 100 mg filmdragerade tabletter
SE/H/0110/003 12439 JANSSEN-CILAG AB SE
Topimax 100 mg filmovertrukne tabletter
SE/H/0110/003 17269 JANSSEN-CILAG A/S DK
Topimax 100 mg filmuhúðaðar töflur
SE/H/0110/003 950035 JANSSEN-CILAG AB IS
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List of nationally authorised medicinal products EMA/641616/2017 Page 54/221
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
Topimax 100 mg tabletter, filmdrasjerte
SE/H/0110/003 95-792 JANSSEN-CILAG A/S NO
Topimax 100 mg tabletti, kalvopäällysteinen
SE/H/0110/003 11953 JANSSEN-CILAG OY FI
Topimax 15 mg hörð hylki
SE/H/0110/007 980529 JANSSEN-CILAG AB IS
Topimax 15 mg kapseli, kova
SE/H/0110/007 16128 JANSSEN-CILAG OY FI
Topimax 15 mg kapslar, hårda
SE/H/0110/007 14348 JANSSEN-CILAG AB SE
Topimax 15 mg kapsler, harde
SE/H/0110/007 98/3715 JANSSEN-CILAG A/S NO
Topimax 15 mg kapsler, hårde
SE/H/0110/007 19589 JANSSEN-CILAG A/S DK
Topimax 200 mg filmdragerade tabletter
SE/H/0110/004 12440 JANSSEN-CILAG AB SE
Topimax 200 mg filmovertrukne tabletter
SE/H/0110/004 17270 JANSSEN-CILAG A/S DK
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List of nationally authorised medicinal products EMA/641616/2017 Page 55/221
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
Topimax 200 mg filmuhúðaðar töflur
SE/H/0110/004 950036 JANSSEN-CILAG AB IS
Topimax 200 mg tabletter, filmdrasjerte
SE/H/0110/004 95-793 JANSSEN-CILAG A/S NO
Topimax 200 mg tabletti, kalvopäällysteinen
SE/H/0110/004 11954 JANSSEN-CILAG OY FI
Topimax 25 mg filmdragerade tabletter
SE/H/0110/001 12437 JANSSEN-CILAG AB SE
Topimax 25 mg filmovertrukne tabletter
SE/H/0110/001 17267 JANSSEN-CILAG A/S DK
Topimax 25 mg filmuhúðaðar töflur
SE/H/0110/001 950033 JANSSEN-CILAG AB IS
Topimax 25 mg hörð hylki
SE/H/0110/008 980530 JANSSEN-CILAG AB IS
Topimax 25 mg kapseli, kova
SE/H/0110/008 16129 JANSSEN-CILAG OY FI
Topimax 25 mg kapslar, hårda
SE/H/0110/008 14349 JANSSEN-CILAG AB SE
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List of nationally authorised medicinal products EMA/641616/2017 Page 56/221
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
Topimax 25 mg kapsler, harde
SE/H/0110/008 98/3716 JANSSEN-CILAG A/S NO
Topimax 25 mg kapsler, hårde
SE/H/0110/008 19590 JANSSEN-CILAG A/S DK
Topimax 25 mg tabletter, filmdrasjerte
SE/H/0110/001 95-790 JANSSEN-CILAG A/S NO
Topimax 25 mg tabletti, kalvopäällysteinen
SE/H/0110/001 11951 JANSSEN-CILAG OY FI
Topimax 50 mg filmdragerade tabletter
SE/H/0110/002 12438 JANSSEN-CILAG AB SE
Topimax 50 mg filmovertrukne tabletter
SE/H/0110/002 17268 JANSSEN-CILAG A/S DK
Topimax 50 mg filmuhúðaðar töflur
SE/H/0110/002 950034 JANSSEN-CILAG AB IS
Topimax 50 mg hörð hylki
SE/H/0110/009 980531 JANSSEN-CILAG AB IS
Topimax 50 mg kapseli, kova
SE/H/0110/009 16130 JANSSEN-CILAG OY FI
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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
Topimax 50 mg kapslar, hårda
SE/H/0110/009 14350 JANSSEN-CILAG AB SE
Topimax 50 mg kapsler, harde
SE/H/0110/009 98/3717 JANSSEN-CILAG A/S NO
Topimax 50 mg kapsler, hårde
SE/H/0110/009 19591 JANSSEN-CILAG A/S DK
Topimax 50 mg tabletter, filmdrasjerte
SE/H/0110/002 95-791 JANSSEN-CILAG A/S NO
Topiramaat 100 mg PCH, filmomhulde tabletten
NO/H/0136/003 RVG 101530 PHARMACHEMIE B.V NL
Topiramaat 200 mg PCH, filmomhulde tabletten
NO/H/0136/004 RVG 101533 PHARMACHEMIE B.V NL
Topiramaat 25 mg PCH, filmomhulde tabletten
NO/H/0136/001 RVG 101527 PHARMACHEMIE B.V NL
Topiramaat 50 mg PCH, filmomhulde tabletten
NO/H/0136/002 RVG 101529 PHARMACHEMIE B.V NL
Topiramaat Accord 100 mg filmomhulde tabletten
UK/H/1438/003 RVG 102980 ACCORD HEALTHCARE LIMITED
NL
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List of nationally authorised medicinal products EMA/641616/2017 Page 58/221
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
Topiramaat Accord 200 mg filmomhulde tabletten
UK/H/1438/004 RVG 102981 ACCORD HEALTHCARE LIMITED
NL
Topiramaat Accord 25 mg filmomhulde tabletten
UK/H/1438/001 RVG 102978 ACCORD HEALTHCARE LIMITED
NL
Topiramaat Accord 50 mg filmomhulde tabletten
UK/H/1438/002 RVG 102979 ACCORD HEALTHCARE LIMITED
NL
Topiramaat Apotex 100 mg, filmomhulde tabletten
NL/H/1231/003 RVG 33206 APOTEX EUROPE B.V. NL
Topiramaat Apotex 200 mg, filmomhulde tabletten
NL/H/1231/004 RVG 33207 APOTEX EUROPE B.V. NL
Topiramaat Apotex 25 mg, filmomhulde tabletten
NL/H/1231/001 RVG 33204 APOTEX EUROPE B.V. NL
Topiramaat Apotex 50 mg, filmomhulde tabletten
NL/H/1231/002 RVG 33205 APOTEX EUROPE B.V. NL
Topiramaat Auro 100 mg, filmomhulde tabletten
PT/H/0231/003 RVG 104817 AUROBINDO PHARMA B.V. NL
Topiramaat Auro 200 mg, filmomhulde tabletten
PT/H/0231/004 RVG 104818 AUROBINDO PHARMA B.V. NL
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List of nationally authorised medicinal products EMA/641616/2017 Page 59/221
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
Topiramaat Auro 25 mg, filmomhulde tabletten
PT/H/0231/001 RVG 104812 AUROBINDO PHARMA B.V. NL
Topiramaat Auro 50 mg, filmomhulde tabletten
PT/H/0231/002 RVG 104816 AUROBINDO PHARMA B.V. NL
Topiramaat Aurobindo 100 mg filmomhulde tabletten
not available RVG 105864 AUROBINDO PHARMA B.V. NL
Topiramaat Aurobindo 200 mg filmomhulde tabletten
not available RVG 105865 AUROBINDO PHARMA B.V. NL
Topiramaat Aurobindo 25 mg filmomhulde tabletten
not available RVG 105862 AUROBINDO PHARMA B.V. NL
Topiramaat Aurobindo 50 mg filmomhulde tabletten
not available RVG 105863 AUROBINDO PHARMA B.V. NL
Topiramaat CF 100 mg, filmomhulde tabletten
NL/H/0947/003 RVG 34571 CENTRAFARM B.V. NL
Topiramaat CF 200 mg, filmomhulde tabletten
NL/H/0947/004 RVG 34572 CENTRAFARM B.V. NL
Topiramaat CF 25 mg, filmomhulde tabletten
NL/H/0947/001 RVG 34569 CENTRAFARM B.V. NL
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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
Topiramaat CF 50 mg, filmomhulde tabletten
NL/H/0947/002 RVG 34570 CENTRAFARM B.V. NL
Topiramaat Desitin 100 mg filmomhulde tabletten
NL/H/0876/003 RVG 34263 DESITIN ARZNEIMITTEL GMBH
NL
Topiramaat Desitin 200 mg filmomhulde tabletten
NL/H/0876/004 RVG 34264 DESITIN ARZNEIMITTEL GMBH
NL
Topiramaat Desitin 25 mg filmomhulde tabletten
NL/H/1202/001 RVG 101285 DESITIN ARZNEIMITTEL GMBH
NL
Topiramaat Desitin 50 mg filmomhulde tabletten
NL/H/1202/002 RVG 101286 DESITIN ARZNEIMITTEL GMBH
NL
Topiramaat Glenmark 100 mg, filmomhulde tabletten
DE/H/0984/003 RVG 103744 GLENMARK PHARMACEUTICALS EUROPE LIMITED
NL
Topiramaat Glenmark 200 mg, filmomhulde tabletten
DE/H/0984/004 RVG 103745 GLENMARK PHARMACEUTICALS EUROPE LIMITED
NL
Topiramaat Glenmark 25 mg, filmomhulde tabletten
DE/H/0984/001 RVG 103742 GLENMARK PHARMACEUTICALS EUROPE LIMITED
NL
Topiramaat Glenmark 50 mg, filmomhulde tabletten
DE/H/0984/002 RVG 103743 GLENMARK PHARMACEUTICALS EUROPE LIMITED
NL
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List of nationally authorised medicinal products EMA/641616/2017 Page 61/221
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
Topiramaat Mylan 100 mg, filmomhulde tabletten
NL/H/0717/003 RVG 33420 MYLAN B.V. NL
Topiramaat Mylan 200 mg, filmomhulde tabletten
NL/H/0717/004 RVG 33421 MYLAN B.V. NL
Topiramaat Mylan 25 mg, filmomhulde tabletten
NL/H/0717/001 RVG 33418 MYLAN B.V. NL
Topiramaat Mylan 50 mg, filmomhulde tabletten
NL/H/0717/002 RVG 33419 MYLAN B.V. NL
Topiramaat Sandoz tablet 100 mg, filmomhulde tabletten
FI/H/0599/003 RVG 33977 SANDOZ B.V. NL
Topiramaat Sandoz tablet 25 mg, filmomhulde tabletten
FI/H/0599/001 RVG 33976 SANDOZ B.V. NL
Topiramaat Torrent 100 mg filmomhulde tabletten
NL/H/1667/001-005 RVG 104612 TORRENT PHARMA GMBH NL
Topiramaat Torrent 200 mg filmomhulde tabletten
NL/H/1667/001-005 RVG 104613 TORRENT PHARMA GMBH NL
Topiramaat Torrent 25 mg filmomhulde tabletten
NL/H/1667/001-005 RVG 104609 TORRENT PHARMA GMBH NL
-
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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
Topiramaat Torrent 400 mg filmomhulde tabletten
NL/H/1667/001-005 RVG 104614 TORRENT PHARMA GMBH NL
Topiramaat Torrent 50 mg filmomhulde tabletten
NL/H/1667/001-005 RVG 104611 TORRENT PHARMA GMBH NL
Topiramat - 1 A Pharma® 100 mg Filmtabletten
DE/H/3334/003 67659.00.00 1 A PHARMA GMBH DE
Topiramat - 1 A Pharma® 15 mg Hartkapseln
DE/H/3334/005 67654.00.00 1 A PHARMA GMBH DE
Topiramat - 1 A Pharma® 25 mg Filmtabletten
DE/H/3334/001 67657.00.00 1 A PHARMA GMBH DE
Topiramat - 1 A Pharma® 25 mg Filmtabletten
DE/H/3334/004 67660.00.00 1 A PHARMA GMBH DE
Topiramat - 1 A Pharma® 25 mg Hartkapseln
DE/H/3334/006 67655.00.00 1 A PHARMA GMBH DE
Topiramat - 1 A Pharma® 50 mg Filmtabletten
DE/H/3334/002 67658.00.00 1 A PHARMA GMBH DE
Topiramat - 1 A Pharma® 50 mg Hartkapseln
DE/H/3334/007 67656.00.00 1 A PHARMA GMBH DE
-
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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
Topiramat Sandoz 100 mg filmdrasjerte tabletter
FI/H/0599/003 06-4082 SANDOZ A/S NO
Topiramat Sandoz 200 mg filmdrasjerte tabletter
FI/H/0599/004 06-4083 SANDOZ A/S NO
Topiramat Sandoz 25 mg filmdrasjerte tabletter
FI/H/0599/001 06-4080 SANDOZ A/S NO
Topiramat Sandoz 50 mg filmdrasjerte tabletter
FI/H/0599/002 06-4081 SANDOZ A/S NO
Topiramat ”Actavis”, filmovertrukne tabletter
PT/H/0231/002 44904 ACTAVIS GROUP PTC EHF. DK
Topiramat ”Actavis”, filmovertrukne tabletter
PT/H/0231/001 44903 ACTAVIS GROUP PTC EHF. DK
Topiramat ”Actavis”, filmovertrukne tabletter
PT/H/0231/004 44906 ACTAVIS GROUP PTC EHF. DK
Topiramat ”Actavis”, filmovertrukne tabletter
PT/H/0231/003 44905 ACTAVIS GROUP PTC EHF. DK
Topiramat ”Amneal”, filmovertrukne tabletter
UK/H/1166/001 41723 AMNEAL PHARMA EUROPE LIMITED
DK
-
List of nationally authorised medicinal products EMA/641616/2017 Page 64/221
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
Topiramat ”Amneal”, filmovertrukne tabletter
UK/H/1166/002 41724 AMNEAL PHARMA EUROPE LIMITED
DK
Topiramat ”Amneal”, filmovertrukne tabletter
UK/H/1166/003 41725 AMNEAL PHARMA EUROPE LIMITED
DK
Topiramat ”Amneal”, filmovertrukne tabletter
UK/H/1166/004 41726 AMNEAL PHARMA EUROPE LIMITED
DK
Topiramat ”Amneal”, filmovertrukne tabletter
UK/H/1166/001 41723 AMNEAL PHARMA EUROPE LIMITED
DK
Topiramat ”Amneal”, filmovertrukne tabletter
UK/H/1166/002 41724 AMNEAL PHARMA EUROPE LIMITED
DK
Topiramat ”Amneal”, filmovertrukne tabletter
UK/H/1166/003 41725 AMNEAL PHARMA EUROPE LIMITED
DK
Topiramat ”Amneal”, filmovertrukne tabletter
UK/H/1166/004 41726 AMNEAL PHARMA EUROPE LIMITED
DK
Topiramat ”Hexal”, filmovertrukne tabletter
DE/H/3333/001 40209 HEXAL A/S DK
Topiramat ”Hexal”, filmovertrukne tabletter
DE/H/3333/002 40210 HEXAL A/S DK
-
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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
Topiramat ”Hexal”, filmovertrukne tabletter
DE/H/3333/003 40211 HEXAL A/S DK
Topiramat ”Hexal”, filmovertrukne tabletter
DE/H/3333/004 40212 HEXAL A/S DK
Topiramat ”Orion”, filmovertrukne tabletter
FI/H/0800/001 42108 ORION CORPORATION DK
Topiramat ”Orion”, filmovertrukne tabletter
FI/H/0800/002 42109 ORION CORPORATION DK
Topiramat ”Orion”, filmovertrukne tabletter
FI/H/0800/003 42110 ORION CORPORATION DK
Topiramat ”Orion”, filmovertrukne tabletter
FI/H/0800/004 42111 ORION CORPORATION DK
Topiramat 1A Farma 100 mg filmdragerade tabletter
FI/H/0599/003 23824 1A FARMA A/S SE
Topiramat 1A Farma 200 mg filmdragerade tabletter
FI/H/0599/004 23825 1A FARMA A/S SE
Topiramat 1A Farma 25 mg filmdragerade tabletter
FI/H/0599/001 23822 1A FARMA A/S SE
-
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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
Topiramat 1A Farma 50 mg filmdragerade tabletter
FI/H/0599/002 23823 1A FARMA A/S SE
Topiramat 1A Pharma 100 mg - Filmtabletten
DE/H/3334/003 1-27614 1A PHARMA GMBH AT
Topiramat 1A Pharma 200 mg - Filmtabletten
DE/H/3334/004 1-27615 1A PHARMA GMBH AT
Topiramat 1A Pharma 25 mg - Filmtabletten
DE/H/3334/001 1-27612 1A PHARMA GMBH AT
Topiramat 1A Pharma 50 mg - Filmtabletten
DE/H/3334/002 1-27613 1A PHARMA GMBH AT
Topiramat Actavis 100 mg comprimate filmate
815/2008/01-23 815/2008/01-23 ACTAVIS GROUP HF. RO
TOPIRAMAT ACTAVIS 100 MG FILMDRAGERADE TABLETTER
PT/H/0231/003 42362 ACTAVIS GROUP PTC EHF. SE
Topiramat Actavis 100 mg Filmtabletten
PT/H/0231/003 1-28639 ACTAVIS GROUP PTC EHF. AT
Topiramat Actavis 100 mg filmuhúðaðar töflur
PT/H/0231/003 IS/1/09/069/03 ACTAVIS GROUP PTC EHF. IS
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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
TOPIRAMAT ACTAVIS 100 MG POTAHOVANÉ TABLETY
PT/H/0231/003 21/607/09-C ACTAVIS GROUP PTC EHF. CZ
TOPIRAMAT ACTAVIS 200 MG FILMDRAGERADE TABLETTER
PT/H/0231/004 42363 ACTAVIS GROUP PTC EHF. SE
Topiramat Actavis 200 mg Filmtabletten
PT/H/0231/004 1-28640 ACTAVIS GROUP PTC EHF. AT
Topiramat Actavis 200 mg filmuhúðaðar töflur
PT/H/0231/004 IS/1/09/069/04 ACTAVIS GROUP PTC EHF. IS
Topiramat Actavis 25 mg comprimate filmate
813/2008/01-21 813/2008/01-21 ACTAVIS GROUP HF. RO
Topiramat Actavis 25 mg filmdragerade tabletter
PT/H/0231/001 42360 ACTAVIS GROUP PTC EHF. SE
Topiramat Actavis 25 mg Filmtabletten
PT/H/0231/001 1-28637 ACTAVIS GROUP PTC EHF. AT
Topiramat Actavis 25 mg filmuhúðaðar töflur
PT/H/0231/001 IS/1/09/069/01 ACTAVIS GROUP PTC EHF. IS
TOPIRAMAT ACTAVIS 25 MG POTAHOVANÉ TABLETY
PT/H/0231/001 21/605/09-C ACTAVIS GROUP PTC EHF. CZ
-
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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
Topiramat Actavis 50 mg comprimate filmate
814/2008/01-21 814/2008/01-21 ACTAVIS GROUP HF. RO
Topiramat Actavis 50 mg film-coated tablets
PT/H/0231/002 42361 ACTAVIS GROUP PTC EHF. SE
Topiramat Actavis 50 mg Filmtabletten
PT/H/0231/002 1-28638 ACTAVIS GROUP PTC EHF. AT
Topiramat Actavis 50 mg filmuhúðaðar töflur
PT/H/0231/002 IS/1/09/069/02 ACTAVIS GROUP PTC EHF. IS
TOPIRAMAT ACTAVIS 50 MG POTAHOVANÉ TABLETY
PT/H/0231/002 21/606/09-C ACTAVIS GROUP PTC EHF. CZ
Topiramat AL 100 mg Filmtabletten
not available 67235.00.00 ALIUD PHARMA GMBH DE
Topiramat AL 200 mg Filmtabletten
not available 67236.00.00 ALIUD PHARMA GMBH DE
Topiramat AL 25 mg Filmtabletten
not available 67233.00.00 ALIUD PHARMA GMBH DE
Topiramat AL 50 mg Filmtabletten
not available 67234.00.00 ALIUD PHARMA GMBH DE
-
List of nationally authorised medicinal products EMA/641616/2017 Page 69/221
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
Topiramat AL Migräne 25 mg Filmtabletten
not available 76480.00.00 ALIUD PHARMA GMBH DE
Topiramat AL Migräne 50 mg Filmtabletten
not available 76481.00.00 ALIUD PHARMA GMBH DE
Topiramat Aurobindo 100 mg comprimate filmate
NL/H/2916/003 7386/2015/01 AUROBINDO PHARMA (MALTA) LIMITED
RO
Topiramat Aurobindo 100 mg comprimate filmate
NL/H/2916/003 7386/2015/02 AUROBINDO PHARMA (MALTA) LIMITED
RO
Topiramat Aurobindo 100 mg Filmtabletten
not available 82082.00.00 AUROBINDO PHARMA GMBH DE
Topiramat Aurobindo 200 mg comprimate filmate
NL/H/2916/004 7387/2015/01 AUROBINDO PHARMA (MALTA) LIMITED
RO
Topiramat Aurobindo 200 mg comprimate filmate
NL/H/2916/004 7387/2015/02 AUROBINDO PHARMA (MALTA) LIMITED
RO
Topiramat Aurobindo 200 mg Filmtabletten
not available 82083.00.00 AUROBINDO PHARMA GMBH DE
Topiramat Aurobindo 25 mg comprimate filmate
NL/H/2916/001 7384/2015/01 AUROBINDO PHARMA (MALTA) LIMITED
RO
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List of nationally authorised medicinal products EMA/641616/2017 Page 70/221
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
Topiramat Aurobindo 25 mg comprimate filmate
NL/H/2916/001 7384/2015/02 AUROBINDO PHARMA (MALTA) LIMITED
RO
Topiramat Aurobindo 25 mg Filmtabletten
not available 82080.00.00 AUROBINDO PHARMA GMBH DE
Topiramat Aurobindo 50 mg comprimate filmate
NL/H/2916/002 7385/2015/01 AUROBINDO PHARMA (MALTA) LIMITED
RO
Topiramat Aurobindo 50 mg comprimate filmate
NL/H/2916/002 7385/2015/02 AUROBINDO PHARMA (MALTA) LIMITED
RO
Topiramat Aurobindo 50 mg Filmtabletten
not available 82081.00.00 AUROBINDO PHARMA GMBH DE
Topiramat Bluefish 100 mg Filmtabletten
AT/H/0612/003 1-29028 BLUEFISH PHARMACEUTICALS AB
AT
Topiramat Bluefish 100 mg Filmtabletten
AT/H/0612/003 74682.00.00 BLUEFISH PHARMACEUTICALS AB
DE
Topiramat Bluefish 100 mg filmuhúðaðar töflur
AT/H/0612/003 IS/1/13/031/03 BLUEFISH PHARMACEUTICALS AB
IS
Topiramat Bluefish 100 mg tabletter, filmdrasjerte
AT/H/0612/003 08-6138 BLUEFISH PHARMACEUTICALS AB
NO
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List of nationally authorised medicinal products EMA/641616/2017 Page 71/221
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
Topiramat Bluefish 200 mg Filmtabletten
AT/H/0612/004 1-29030 BLUEFISH PHARMACEUTICALS AB
AT
Topiramat Bluefish 200 mg Filmtabletten
AT/H/0612/004 74683.00.00 BLUEFISH PHARMACEUTICALS AB
DE
Topiramat Bluefish 200 mg filmuhúðaðar töflur
AT/H/0612/004 IS/1/13/031/04 BLUEFISH PHARMACEUTICALS AB
IS
Topiramat Bluefish 200 mg tabletter, filmdrasjerte
AT/H/0612/004 08-6139 BLUEFISH PHARMACEUTICALS AB
NO
Topiramat Bluefish 25 mg Filmtabletten
AT/H/0612/001 1-29026 BLUEFISH PHARMACEUTICALS AB
AT
Topiramat Bluefish 25 mg Filmtabletten
AT/H/0612/001 74680.00.00 BLUEFISH PHARMACEUTICALS AB
DE
Topiramat Bluefish 25 mg filmuhúðaðar töflur
AT/H/0612/001 IS/1/13/031/01 BLUEFISH PHARMACEUTICALS AB
IS
Topiramat Bluefish 25 mg tabletter, filmdrasjerte
AT/H/0612/001 08-6136 BLUEFISH PHARMACEUTICALS AB
NO
Topiramat Bluefish 50 mg Filmtabletten
AT/H/0612/002 1-29027 BLUEFISH PHARMACEUTICALS AB
AT
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List of nationally authorised medicinal products EMA/641616/2017 Page 72/221
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
Topiramat Bluefish 50 mg Filmtabletten
AT/H/0612/002 74681.00.00 BLUEFISH PHARMACEUTICALS AB
DE
Topiramat Bluefish 50 mg filmuhúðaðar töflur
AT/H/0612/002 IS/1/1