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7 Westferry Circus ● Canary Wharf ● London E14 4HB ● United Kingdom
An agency of the European Union
Telephone +44 (0)20 7418 8400 Facsimile +44 (0)20 7418 8416
E-mail [email protected] Website www.ema.europa.eu
© European Medicines Agency, 2013. Reproduction is authorised provided the source is acknowledged.
05 November 2013 EMA/678403/2013 Referrals
Annex I
List of the names, pharmaceutical forms, strengths of the medicinal
products, routes of administration, marketing authorisation holders in the
member states for valproate and related substances
Article 31 of Directive 2001/83/EC
Procedure number: EMEA/H/A-31/1387
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 2/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Austria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 100
mg/ml -
Injektionslösung
Valproic acid 100 mg/ml
(sodium
valproate)
solution for
injection/infusion
Intravenous Use
Austria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 150 mg -
Kapseln
Valproic acid 150 mg Gastro-resistant
capsule, soft
Oral Use
Austria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 300 mg -
Kapseln
Valproic acid 300 mg Gastro-resistant
capsule, soft
Oral Use
Austria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 500 mg -
Kapseln
Valproic acid 500 mg Gastro-resistant
capsule, soft
Oral Use
Austria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 300 mg -
Retardtabletten
sodium valproate 300 mg Prolonged-release
tablet
Oral Use
Austria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 500 mg -
Retardtabletten
sodium valproate 500 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 3/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Austria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 300
mg/ml - Lösung
zum Einnehmen
sodium valproate 300 mg/ml Oral solution Oral Use
Austria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 50 mg/ml
- Sirup für Kinder
Valproic acid 50 mg/ml
(sodium
valproate)
Syrup Oral Use
Austria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Natriumvalproat
G.L. 300 mg -
Retardtabletten
sodium valproate 300 mg Prolonged-release
tablet
Oral Use
Austria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Natriumvalproat
G.L. 500 mg -
Retardtabletten
sodium valproate 500 mg Prolonged-release
tablet
Oral Use
Austria sanofi-aventis GmbH
SATURN Tower,
Vienna DC
Leonard-Bernstein-
Straße 10
1220 Wien
Austria
Depakine
Chronosphere 50
mg -
Retardgranulat in
Beuteln
Sodium valproate,
Valproic acid
33,33 mg
sodium
valproate +
14,51 mg
valproic acid
(equivalent to
50 mg sodium
valproate)
Prolonged-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 4/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Austria sanofi-aventis GmbH
SATURN Tower,
Vienna DC
Leonard-Bernstein-
Straße 10
1220 Wien
Austria
Depakine
Chronosphere 100
mg -
Retardgranulat in
Beuteln
Sodium valproate,
Valproic acid
66.66 mg
sodium
valproate +
29.02 mg
valproic acid (=
100 mg sodium
valproate)
Prolonged-release
granules
Oral Use
Austria sanofi-aventis GmbH
SATURN Tower,
Vienna DC
Leonard-Bernstein-
Straße 10
1220 Wien
Austria
Depakine
Chronosphere 250
mg -
Retardgranulat in
Beuteln
Sodium valproate,
Valproic acid
166,76 mg
sodium
valproate +
72,61 mg
valproic acid
(equivalent to
250 mg sodium
valproate)
Prolonged-release
granules
Oral Use
Austria sanofi-aventis GmbH
SATURN Tower,
Vienna DC
Leonard-Bernstein-
Straße 10
1220 Wien
Austria
Depakine
Chronosphere 500
mg -
Retardgranulat in
Beuteln
Sodium valproate,
Valproic acid
333.3 mg
sodium
valproate +
145.09 mg
valproic acid (=
500 mg sodium
valproate)
Prolonged-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 5/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Austria sanofi-aventis GmbH
SATURN Tower,
Vienna DC
Leonard-Bernstein-
Straße 10
1220 Wien
Austria
Depakine
Chronosphere 750
mg -
Retardgranulat in
Beuteln
Sodium valproate,
Valproic acid
500.05 mg
sodium
valproate +
217.68 mg
valproic acid (=
750 mg sodium
valproate)
Prolonged-release
granules
Oral Use
Austria sanofi-aventis GmbH
SATURN Tower,
Vienna DC
Leonard-Bernstein-
Straße 10
1220 Wien
Austria
Depakine
Chronosphere 1000
mg -
Retardgranulat in
Beuteln
Sodium valproate,
Valproic acid
666.58 mg
sodium
valproate +
290.18 mg
valproic acid (=
1000 mg
sodium
valproate)
Prolonged-release
granules
Oral Use
Austria sanofi-aventis GmbH
SATURN Tower,
Vienna DC
Leonard-Bernstein-
Straße 10
1220 Wien
Austria
Depakine chrono
retard 300 mg
Filmtabletten
Sodium valproate,
Valproic acid
199,8 mg
sodium
valproate + 87
mg valproic
acid
(equivalent to
300 mg sodium
valproate)
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 6/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Austria sanofi-aventis GmbH
SATURN Tower,
Vienna DC
Leonard-Bernstein-
Straße 10
1220 Wien
Austria
Depakine chrono
retard 500 mg
Filmtabletten
Sodium valproate,
Valproic acid
333 mg sodium
valproate +
145 mg
valproic acid
(equivalent to
500 mg sodium
valproate)
Prolonged-release
tablet
Oral Use
Austria sanofi-aventis GmbH
SATURN Tower,
Vienna DC
Leonard-Bernstein-
Straße 10
1220 Wien
Austria
Depakine
Trockenstechampul
le mit
Lösungsmittel
sodium valproate 400 mg
/ampoule
Lyophilisate and
solvent for
suspension for
injection
Intravenous Use
Austria sanofi-aventis GmbH
SATURN Tower,
Vienna DC
Leonard-Bernstein-
Straße 10
1220 Wien
Austria
Depakine 300
mg/ml Tropfen
sodium valproate 300 mg/ml Oral solution Oral Use
Belgium Takeda Belgium
Gentsesteenweg 615
1080 Brussels
Belgium
Convulex 300 mg Valproic acid 300 mg Capsule, hard Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 7/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Belgium Takeda Belgium
Gentsesteenweg 615
1080 Brussels
Belgium
Convulex 500 mg Valproic acid 500 mg Gastro-resistant
capsule, hard
Oral Use
Belgium Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine Valproate sodium 300 mg/ml Oral drops, solution Oral Use
Belgium Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine 300 mg/5
ml
Valproate sodium 60 mg/ml Syrup Oral Use
Belgium Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine Chrono
300
Valproate sodium,
Valproic acid
200 mg,
87 mg
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 8/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Belgium Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine Chrono
500
Valproate sodium,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Belgium Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine Enteric
150 mg
Valproate sodium 150 mg Tablet Oral Use
Belgium Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine Enteric
300 mg
Valproate sodium 300 mg Tablet Oral Use
Belgium Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine Enteric
500 mg
Valproate sodium 500 mg Tablet Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 9/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Belgium Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine IV 400
mg
Valproate sodium 400 mg Powder and solvent
for solution for
injection
Intravenous Use
Belgium Mylan BVBA/SPRL
Terhulpsesteenweg 6
box A
1560 Hoeilaart
Belgium
Valproate Mylan Valproate sodium 100 mg/ml Solution for
injection/infusion
Intravenous Use
Belgium Eurogenerics N.V.
Heizel Esplanade
b22
1020 Brussels
Belgium
Valproate Retard
EG 300 mg
Valproate sodium,
Valproic acid
200 mg,
87 mg
Prolonged-release
tablet
Oral Use
Belgium Eurogenerics N.V.
Heizel Esplanade
b22
1020 Brussels
Belgium
Valproate Retard
EG 500 mg
Valproate sodium,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Bulgaria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Chrono Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 10/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Bulgaria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Chrono Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Bulgaria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Valproic acid 500 mg Gastro-resistant
capsule, soft
Oral Use
Bulgaria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Valproic acid 300 mg Gastro-resistant
capsule, soft
Oral Use
Bulgaria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Sodium Valproate 50 mg/ml Syrup Oral Use
Bulgaria G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Sodium Valproate 100 mg/ml Solution for
injection/infusion
Intravenous Use
Bulgaria Sanofi-Aventis
Bulgaria EOOD
103, Alexander
Stamboliiski Blvd
1303 Sofia
Bulgaria
Depakine Sodium Valproate 400 mg Powder and solvent
for solution for
injection
Intravenous Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 11/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Bulgaria Sanofi-Aventis
Bulgaria EOOD
103, Alexander
Stamboliiski Blvd
1303 Sofia
Bulgaria
Depakine Sodium Valproate 57.64 mg/ml Syrup Oral Use
Bulgaria Sanofi-Aventis
Bulgaria EOOD
103, Alexander
Stamboliiski Blvd
1303 Sofia
Bulgaria
Depakine Sodium Valproate 500 mg Gastro-resistant
tablet
Oral Use
Bulgaria Sanofi-Aventis
Bulgaria EOOD
103, Alexander
Stamboliiski Blvd
1303 Sofia
Bulgaria
Depakine Chrono Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
Bulgaria Sanofi-Aventis
Bulgaria EOOD
103, Alexander
Stamboliiski Blvd
1303 Sofia
Bulgaria
Depakine Chrono Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 12/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Croatia Sanofi-Aventis
Croatia d.o.o.
Heinzelova 70
Zagreb 10 000
Croatia
DEPAKINE CHRONO
300 mg filmom
obložene tablete
Valproic Acid,
Sodium Valproate
87 mg valproic
acid + 199.8
mg sodim
valproate
(equivalent to
300 mg sodium
valproate)
Modified-release
tablet
Oral Use
Croatia Sanofi-Aventis
Croatia d.o.o.
Heinzelova 70
Zagreb 10 000
Croatia
DEPAKINE CHRONO
500 mg filmom
obložene tablete
Valproic Acid,
Sodium Valproate
145 mg
valproic acid +
333 mg sodium
valproate
(equivalent to
500 mg sodium
valproate)
Modified-release
tablet
Oral Use
Cyprus Sanofi-Aventis
Cyprus Ltd
Charalambou
Mouskou 14 Street
2015 Strovolos
Nicosia
Cyprus
Depakine Chrono valproate sodium 500 mg Prolonged-release
tablet
Oral Use
Cyprus Sanofi-Aventis
Cyprus Ltd
Charalambou
Mouskou 14 Street
2015 Strovolos
Nicosia
Cyprus
Depakine
Chronosphere
Valproate sodium,
Valproic acid
500 mg Modified-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 13/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Cyprus Sanofi-Aventis
Cyprus Ltd
Charalambou
Mouskou 14 Street
2015 Strovolos
Nicosia
Cyprus
Depakine
Chronosphere
Valproate sodium,
Valproic acid
750 mg Modified-release
granules
Oral Use
Cyprus Sanofi-Aventis
Cyprus Ltd
Charalambou
Mouskou 14 Street
2015 Strovolos
Nicosia
Cyprus
Depakine
Chronosphere
Valproate sodium,
Valproic acid
1000 mg Modified-release
granules
Oral Use
Cyprus Remedica Ltd
Aharnon Street
Limassol Industrial
Estate
3056 Lemesos
Cyprus
Petilin valproate sodium 200 mg Gastro-resistant
tablet
Oral Use
Cyprus Remedica Ltd
Aharnon Street
Limassol Industrial
Estate
3056 Lemesos
Cyprus
Petilin valproate sodium 500 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 14/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Cyprus Remedica Ltd
Aharnon Street
Limassol Industrial
Estate
3056 Lemesos
Cyprus
Petilin valproate sodium 200 mg / 5 ml Syrup Oral Use
Czech Republic Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Valproat Chrono
Sandoz 300 mg
Sodium valproate,
Valproic acid
200 mg,
87 mg
Prolonged-release
tablet
Oral Use
Czech Republic Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
Valproat Chrono
Sandoz 500 mg
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Czech Republic Sanofi-Aventis, s.r.o.
Evropská 846/176a
160 00 Prague 6
Czech Republic
Depakine Chrono
500 mg Sécable
Sodium valproate,
Valproic acid
333 mg,
145 mg
Modified-release
tablet
Oral Use
Czech Republic Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Valproat-
ratiopharm Chrono
300 mg
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Czech Republic Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Valproat-
ratiopharm Chrono
500 mg
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 15/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Czech Republic G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Sodium Valproate 30 mg Oral drops, solution Oral Use
Czech Republic G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Sodium Valproate 50 mg/ml Syrup Oral Use
Czech Republic G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 150 Valproic acid 150 mg Capsule, soft Oral Use
Czech Republic G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 300 Valproic acid 300 mg Capsule, soft Oral Use
Czech Republic G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 500 Valproic acid 500 mg Capsule, soft Oral Use
Czech Republic G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex CR 500
mg
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Czech Republic G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex CR 300
mg
Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 16/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Czech Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Long 150 mg Sodium Valproate 150 mg Prolonged-release
capsule, hard
Oral Use
Czech Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Long 300 mg Sodium Valproate 300 mg Prolonged-release
capsule, hard
Oral Use
Czech Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Long 500 mg Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Czech Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Long 1000
mg
Sodium Valproate 1000 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 17/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Czech Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 300 Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Czech Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 150 Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Czech Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril I.V. Sodium Valproate 300 mg Solution for
injection
Intravenous Use
Czech Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 600 Sodium Valproate 600 mg Gastro-resistant
tablet
Oral Use
Czech Republic Sanofi-Aventis, s.r.o.
Evropská 846/176a
160 00 Prague 6
Czech Republic
Depakine Sodium Valproate 5.764 g / 100
ml
Syrup Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 18/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Czech Republic Sanofi-Aventis, s.r.o.
Evropská 846/176a
160 00 Prague 6
Czech Republic
Depakine Sodium Valproate 400 mg / 4 ml Powder and solvent
for solution for
injection
Intravenous Use
Czech Republic Sanofi-Aventis, s.r.o.
Evropská 846/176a
160 00 Prague 6
Czech Republic
Depakine Chrono
300 mg Sécable
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Modified-release
tablet
Oral Use
Czech Republic Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor 300 mg Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
Czech Republic Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor 500 mg Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Denmark Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Valproic acid 300 mg Gastro-resistant
tablet
Oral Use
Denmark Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Valproic acid 600 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 19/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Denmark Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Valproic acid 60 mg/ml Oral solution Oral Use
Denmark Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Valproic acid 100 mg/ml Solution for
injection
Intravenous Use
Denmark Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Long Valproic acid 150 mg Prolonged-release
capsule
Oral Use
Denmark Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Long Valproic acid 300 mg Prolonged-release
capsule
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 20/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Denmark Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Long Valproic acid 500 mg Prolonged-release
granules
Oral Use
Denmark Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Long Valproic acid 1000 mg Prolonged-release
granules
Oral Use
Denmark Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Retard Valproic acid 300 mg Prolonged-release
tablet
Oral Use
Denmark Sandoz A/S
Edvard Thomsens
Vej 14
DK-2300 København
S
Denmark
Valproat "Sandoz" Valproic acid 300 mg Prolonged-release
capsule
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 21/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Denmark Sandoz A/S
Edvard Thomsens
Vej 14
DK-2300 København
S
Denmark
Valproat "Sandoz" Valproic acid 500 mg Prolonged-release
capsule
Oral Use
Denmark Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Delepsine Valproic acid 300 mg Tablet Oral Use
Denmark Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Delepsine Valproic acid 100 mg Gastro-resistant
tablet
Oral Use
Denmark Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Delepsine Valproic acid 300 mg Gastro-resistant
tablet
Oral Use
Denmark Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Delepsine Valproic acid 500 mg Gastro-resistant
tablet
Oral Use
Denmark Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Delepsine Valproic acid 60 mg/ml Oral solution Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 22/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Denmark Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Delepsine Valproic acid 200 mg/ml Oral drops, solution Oral Use
Denmark Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Delepsine Valproic acid 300 mg Suppository Rectal use
Denmark Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Delepsine Retard Valproic acid 300 mg Prolonged-release
tablet
Oral Use
Denmark Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Delepsine Retard Valproic acid 500 mg Prolonged-release
tablet
Oral Use
Denmark Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Deprakine Valproic acid 300 mg Gastro-resistant
tablet
Oral Use
Denmark Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Deprakine Valproic acid 500 mg Gastro-resistant
tablet
Oral Use
Denmark Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Deprakine Retard Valproic acid 300 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 23/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Denmark Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Deprakine Retard Valproic acid 500 mg Prolonged-release
tablet
Oral Use
Estonia Sanofi-Aventis
Estonia OÜ
Pärnu mnt 139E/2
11317 Tallinn
Estonia
DEPAKINE CHRONO
500 MG
Valproic acid 500 mg Prolonged-release
tablet
Oral Use
Estonia Sanofi-Aventis
Estonia OÜ
Pärnu mnt 139E/2
11317 Tallinn
Estonia
DEPAKINE CHRONO
300 MG
Valproic acid 300 mg Prolonged-release
tablet
Oral Use
Estonia Sanofi-Aventis
Estonia OÜ
Pärnu mnt 139E/2
11317 Tallinn
Estonia
DEPAKINE Valproic acid 400 mg Powder and solvent
for solution for
injection
Intravenous Use
Estonia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
CONVULEX Valproic acid 100 mg/ml Solution for
injection/infusion
Intravenous Use
Estonia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
CONVULEX 300
MG/ML
Valproic acid 300 mg/ml Oral drops, solution Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 24/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Estonia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
CONVULEX Valproic acid 50 mg/ml Syrup Oral Use
Estonia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
CONVULEX 150 MG Valproic acid 150 mg Gastro-resistant
capsule, soft
Oral Use
Estonia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
CONVULEX 300 MG Valproic acid 300 mg Gastro-resistant
capsule, soft
Oral Use
Estonia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
CONVULEX 500 MG Valproic acid 500 mg Gastro-resistant
capsule, soft
Oral Use
Estonia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
CONVULEX RETARD
300MG
Valproic acid 300 mg Prolonged-release
tablet
Oral Use
Estonia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
CONVULEX RETARD
500MG
Valproic acid 500 mg Prolonged-release
tablet
Oral Use
Estonia Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
ABSENOR Valproic acid 300 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 25/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Estonia Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
ABSENOR Valproic acid 500 mg Prolonged-release
tablet
Oral Use
Estonia Sandoz d.d.
Verovškova 57
SI-1000 Ljubljana
Slovenia
VALPROATE
SODIUM SANDOZ
300MG
Valproic acid 300 mg Prolonged-release
tablet
Oral Use
Estonia Sandoz d.d.
Verovškova 57
SI-1000 Ljubljana
Slovenia
VALPROATE
SODIUM SANDOZ
500MG
Valproic acid 500 mg Prolonged-release
tablet
Oral Use
Estonia Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL SAFT Valproic acid 60 mg/ml Oral solution Oral Use
Estonia Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL Valproic acid 100 mg/ml Solution for
injection
Intravenous Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 26/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Estonia Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL 300 Valproic acid 300 mg Gastro-resistant
tablet
Oral Use
Estonia Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL 150 Valproic acid 150 mg Gastro-resistant
tablet
Oral Use
Estonia Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL 600 Valproic acid 600 mg Gastro-resistant
tablet
Oral Use
Estonia Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL LONG 150
MG
Valproic acid 150 mg Prolonged-release
capsule
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 27/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Estonia Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL LONG 300
MG
Valproic acid 300 mg Prolonged-release
capsule
Oral Use
Estonia Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL LONG 500
MG
Valproic acid 500 mg Prolonged-release
capsule
Oral Use
Estonia Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL LONG
1000 MG
Valproic acid 1000 mg Prolonged-release
capsule
Oral Use
Finland Orion Pharma
Orionintie 1
PL 65
02101 Espoo
Finland
ABSENOR Sodium Valproate 100 mg Gastro-resistant
tablet
Oral Use
Finland Orion Pharma
Orionintie 1
PL 65
02101 Espoo
Finland
ABSENOR Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 28/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Finland Orion Pharma
Orionintie 1
PL 65
02101 Espoo
Finland
ABSENOR Sodium Valproate 500 mg Gastro-resistant
tablet
Oral Use
Finland Orion Pharma
Orionintie 1
PL 65
02101 Espoo
Finland
ABSENOR Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
Finland Orion Pharma
Orionintie 1
PL 65
02101 Espoo
Finland
ABSENOR Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Finland Orion Pharma
Orionintie 1
PL 65
02101 Espoo
Finland
ABSENOR Sodium Valproate 60 mg/ml Oral solution Oral Use
Finland Orion Pharma
Orionintie 1
PL 65
02101 Espoo
Finland
ABSENOR Sodium Valproate 200 mg/ml Oral drops, solution Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 29/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Finland Sanofi-aventis Oy
Huopalahdentie 24
PL 22
00351 Helsinki
Finland
DEPRAKINE Sodium Valproate 100 mg Gastro-resistant
tablet
Oral Use
Finland Sanofi-aventis Oy
Huopalahdentie 24
PL 22
00351 Helsinki
Finland
DEPRAKINE Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Finland Sanofi-aventis Oy
Huopalahdentie 24
PL 22
00351 Helsinki
Finland
DEPRAKINE Sodium Valproate 500 mg Gastro-resistant
tablet
Oral Use
Finland Sanofi-aventis Oy
Huopalahdentie 24
PL 22
00351 Helsinki
Finland
DEPRAKINE Sodium valproate,
Valproic acid
300 mg Prolonged-release
tablet
Oral Use
Finland Sanofi-aventis Oy
Huopalahdentie 24
PL 22
00351 Helsinki
Finland
DEPRAKINE Sodium valproate,
Valproic acid
500 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 30/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Finland Sanofi-aventis Oy
Huopalahdentie 24
PL 22
00351 Helsinki
Finland
DEPRAKINE Sodium Valproate 60 mg/ml Oral solution Oral Use
Finland Sanofi-aventis Oy
Huopalahdentie 24
PL 22
00351 Helsinki
Finland
DEPRAKINE Sodium Valproate 200 mg/ml Oral drops, solution Oral Use
Finland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
NATRIUMVALPROA
ATTI LONG
DESITIN
Sodium Valproate 150 mg Prolonged-release
capsule, hard
Oral Use
Finland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
NATRIUMVALPROA
ATTI LONG
DESITIN
Sodium Valproate 300 mg Prolonged-release
capsule, hard
Oral Use
Finland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
NATRIUMVALPROA
ATTI LONG
DESITIN
Sodium Valproate 500 mg Prolonged-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 31/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Finland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
NATRIUMVALPROA
ATTI LONG
DESITIN
Sodium Valproate 1000 mg Prolonged-release
granules
Oral Use
Finland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL Sodium Valproate 100 mg/ml Solution for
injection
Intravenous Use
Finland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL LONG Sodium Valproate 150 mg Prolonged-release
capsule, hard
Oral Use
Finland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL LONG Sodium Valproate 300 mg Prolonged-release
capsule, hard
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 32/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Finland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL LONG Sodium Valproate 500 mg Prolonged-release
granules
Oral Use
Finland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL LONG Sodium Valproate 1000 mg Prolonged-release
granules
Oral Use
Finland Sandoz A/S
C. F. Tietgens
Boulevard 40
5220 ODENSE SØ
Denmark
VALPROAT SANDOZ Sodium valproate,
Valproic acid
300 mg Prolonged-release
tablet
Oral Use
Finland Sandoz A/S
C. F. Tietgens
Boulevard 40
5220 ODENSE SØ
Denmark
VALPROAT SANDOZ Sodium valproate,
Valproic acid
500 mg Prolonged-release
tablet
Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
DEPAKINE 200 mg,
comprimé gastro-
résistant
Sodium Valproate 200 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 33/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
DEPAKINE 200
mg/ml, solution
buvable
Sodium Valproate 200 mg/ml Oral solution Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
DEPAKINE 400
mg/4 ml,
préparation
injectable pour voie
I.V.
Sodium Valproate 400 mg / 4 ml Solution for
injection
IV
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
DEPAKINE 500 mg,
comprimé gastro-
résistant
Sodium Valproate 500 mg Gastro-resistant
tablet
Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
DEPAKINE 57,64
mg/ml, sirop
Sodium Valproate 57.64 mg Syrup Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 34/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
DEPAKINE CHRONO
500 mg, comprimé
pelliculé sécable à
libération
prolongée
Valproic Acid,
Sodium Valproate
500 mg Prolonged-release
tablet
Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
DEPAKOTE 250 mg,
comprimé gastro-
résistant
Valproate Semisodium 250 mg Gastro-resistant
tablet
Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
DEPAKOTE 500 mg,
comprimé gastro-
résistant
Valproate Semisodium 500 mg Gastro-resistant
tablet
Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
DEPAMIDE 300 mg,
comprimé pelliculé
gastro-résistant
Valpromide 300 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 35/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
MICROPAKINE L.P.
100 mg, granulés à
libération
prolongée en
sachet-dose
Valproic Acid,
Sodium Valproate
100 mg Prolonged-release
granules
Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
MICROPAKINE L.P.
1000 mg, granulés
à libération
prolongée en
sachet-dose
Valproic Acid,
Sodium Valproate
1000 mg Prolonged-release
granules
Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
MICROPAKINE L.P.
250 mg, granulés à
libération
prolongée en
sachet-dose
Valproic Acid,
Sodium Valproate
250 mg Prolonged-release
granules
Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
MICROPAKINE L.P.
500 mg, granulés à
libération
prolongée en
sachet-dose
Valproic Acid,
Sodium Valproate
500 mg Prolonged-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 36/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
MICROPAKINE L.P.
750 mg, granulés à
libération
prolongée en
sachet-dose
Valproic Acid,
Sodium Valproate
750 mg Prolonged-release
granules
Oral Use
France CLIPA
17, Parc des Vautes
34983 Saint Gely du
Fesc
France
VALPROATE DE
SODIUM ACIDE
VALPROIQUE CLIPA
L.P. 300 mg,
comprimé pelliculé
sécable à libération
prolongée
Valproic Acid,
Sodium Valproate
300 mg Prolonged-release
tablet
Oral Use
France Laboratoire
AGUETTANT
1, rue Alexander
Fleming
69007 Lyon
France
VALPROATE DE
SODIUM
AGUETTANT 400
mg/4 ml, solution
injectable
Sodium Valproate 400 mg / 4 ml Solution for
injection
IV
France LABORATOIRES
ALTER
3, avenue de la
Baltique,
ZI de Courtaboeuf
91140 Villebon Sur
Yvette
France
VALPROATE DE
SODIUM ALTER L.P.
500 mg, comprimé
pelliculé sécable à
libération
prolongée
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 37/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
France Arrow Generiques
26, avenue Tony
Garnier
69007 Lyon
France
VALPROATE DE
SODIUM ARROW
200 mg/ml,
solution buvable
Sodium Valproate 200 mg Oral solution Oral Use
France Arrow Generiques
26, avenue Tony
Garnier
69007 Lyon
France
VALPROATE DE
SODIUM ARROW
L.P. 500 mg,
comprimé pelliculé
sécable à libération
prolongée
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
France Biogaran
15, boulevard
Charles de Gaulle
92700 Colombes
France
VALPROATE DE
SODIUM
BIOGARAN L.P. 500
mg, comprimé
pelliculé sécable à
libération
prolongée
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
VALPROATE DE
SODIUM DAKOTA
PHARM 200 mg,
comprimé gastro-
résistant
Sodium Valproate 200 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 38/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
VALPROATE DE
SODIUM DAKOTA
PHARM 500 mg,
comprimé gastro-
résistant
Sodium Valproate 500 mg Gastro-resistant
tablet
Oral Use
France EG LABO -
Laboratoires
EuroGenerics
"Le Quintet" -
bâtiment A
12, rue Danjou
92517 Boulogne
Billancourt Cedex
France
VALPROATE DE
SODIUM EG L.P.
500 mg, comprimé
pelliculé sécable à
libération
prolongée
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
France SANDOZ
49, avenue Georges
Pompidou
92300 Levallois-
Perret
France
VALPROATE DE
SODIUM GNR L.P.
500 mg, comprimé
pelliculé sécable à
libération
prolongée
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
France MYLAN SAS
117, allée des Parcs
69800 Saint-Priest
France
VALPROATE DE
SODIUM MYLAN
L.P. 500 mg,
comprimé pelliculé
sécable à libération
prolongée
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 39/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
France Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
VALPROATE DE
SODIUM
RATIOPHARM L.P.
500 mg, comprimé
pelliculé sécable à
libération
prolongée
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
France RANBAXY
PHARMACIE
GENERIQUES
11-15 Quai Dion
Bouton
92800 Puteaux
France
VALPROATE DE
SODIUM RPG L.P.
500 mg, comprimé
pelliculé sécable à
libération
prolongée
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
France SANDOZ
49, avenue Georges
Pompidou
92300 Levallois-
Perret
France
VALPROATE DE
SODIUM SANDOZ
LP 500 mg,
comprimé pelliculé
sécable à libération
prolongée
Valproic Acid,
Sodium Valproate
500 mg Prolonged-release
tablet
Oral Use
France TEVA SANTE
110, Esplanade du
Général de Gaulle
92931 Paris La
Défense Cedex
France
VALPROATE DE
SODIUM TEVA L.P.
500 mg, comprimé
pelliculé sécable à
libération
prolongée
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 40/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
VALPROATE DE
SODIUM ZENTIVA
200 mg, comprimé
gastro-résistant
Sodium Valproate 200 mg Gastro-resistant
tablet
Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
VALPROATE DE
SODIUM ZENTIVA
200 mg/ml,
solution buvable
Sodium Valproate 200 mg Oral solution Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
VALPROATE DE
SODIUM ZENTIVA
500 mg, comprimé
gastro-résistant
Sodium Valproate 500 mg Gastro-resistant
tablet
Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
VALPROATE DE
SODIUM ZENTIVA
L.P. 500 mg,
comprimé pelliculé
sécable à libération
prolongée
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 41/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
VALPROATE DE
SODIUM-ACIDE
VALPROIQUE
DELALANDE L.P.
100 mg, granulés à
libération
prolongée en
sachet-dose
Valproic Acid,
Sodium Valproate
100 mg Prolonged-release
granules
Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
VALPROATE DE
SODIUM-ACIDE
VALPROIQUE
DELALANDE L.P.
1000 mg, granulés
à libération
prolongée en
sachet-dose
Valproic Acid,
Sodium Valproate
1000 mg Prolonged-release
granules
Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
VALPROATE DE
SODIUM-ACIDE
VALPROIQUE
DELALANDE L.P.
250 mg, granulés à
libération
prolongée en
sachet-dose
Valproic Acid,
Sodium Valproate
250 mg Prolonged-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 42/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
VALPROATE DE
SODIUM-ACIDE
VALPROIQUE
DELALANDE L.P. 50
mg, granulés à
libération
prolongée en
sachet-dose
Valproic Acid,
Sodium Valproate
50 mg Prolonged-release
granules
Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
VALPROATE DE
SODIUM-ACIDE
VALPROIQUE
DELALANDE L.P.
500 mg, granulés à
libération
prolongée en
sachet-dose
Valproic Acid,
Sodium Valproate
500 mg Prolonged-release
granules
Oral Use
France SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
VALPROATE DE
SODIUM-ACIDE
VALPROIQUE
DELALANDE L.P.
750 mg, granulés à
libération
prolongée en
sachet-dose
Valproic Acid,
Sodium Valproate
750 mg Prolonged-release
granules
Oral Use
Germany 1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany
Valproat - 1 A
Pharma 150 mg
magensaftresistent
e Filmtabletten
Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 43/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany 1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany
Valproat - 1 A
Pharma 300 mg
magensaftresistent
e Filmtabletten
Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Germany 1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany
Valproat - 1 A
Pharma 300 mg
Retardtabletten
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany 1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany
Valproat - 1 A
Pharma 500 mg
Retardtabletten
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Germany 1 A Pharma GmbH
Keltenring 1 + 3
82041 Oberhaching
Germany
Valproat - 1 A
Pharma 600 mg
magensaftresistent
e Filmtabletten
Sodium Valproate 600 mg Gastro-resistant
tablet
Oral Use
Germany AbZ-Pharma GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Valproat AbZ 300
mg Retardtabletten
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany AbZ-Pharma GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Valproat AbZ 500
mg Retardtabletten
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 44/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany ALIUD PHARMA
GmbH
Gottlieb-Daimler-Str.
19
89150 Laichingen
Germany
Valpro AL 300 mg
Retardtabletten
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany ALIUD PHARMA
GmbH
Gottlieb-Daimler-Str.
19
89150 Laichingen
Germany
Valpro AL 500 mg
Retardtabletten
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Germany Aristo Pharma GmbH
Wallenroder Str. 8-
10
13435 Berlin
Germany
espa-valept 300
mg retard
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany Aristo Pharma GmbH
Wallenroder Str. 8-
10
13435 Berlin
Germany
espa-valept 500
mg retard
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Germany Aristo Pharma GmbH
Wallenroder Str. 8-
10
13435 Berlin
Germany
Valproat Aristo 300
mg
magensaftresistent
e Filmtabletten
Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 45/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Aristo Pharma GmbH
Wallenroder Str. 8-
10
13435 Berlin
Germany
Valproat Aristo 600
mg
magensaftresistent
e Filmtabletten
Sodium Valproate 600 mg Gastro-resistant
tablet
Oral Use
Germany betapharm
Arzneimittel
GmbH
Kobelweg 95
86156 Augsburg
Germany
Valpro beta Sodium Valproate 300 mg Oral solution Oral Use
Germany betapharm
Arzneimittel
GmbH
Kobelweg 95
86156 Augsburg
Germany
Valpro beta 300 Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Germany betapharm
Arzneimittel
GmbH
Kobelweg 95
86156 Augsburg
Germany
Valpro beta chrono
300 mg
Retardtabletten
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 46/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany betapharm
Arzneimittel
GmbH
Kobelweg 95
86156 Augsburg
Germany
Valpro beta chrono
500 mg
Retardtabletten
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Germany CT Arzneimittel
GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Valproat chrono-CT
300 mg
Retardtabletten
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany CT Arzneimittel
GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Vaproat chrono-CT
500 mg
Retardtabletten
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Germany CT Arzneimittel
GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Valproat-CT 150mg
Filmtabletten
Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Germany CT Arzneimittel
GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Valproat-CT 300
mg Filmtabletten
Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 47/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany CT Arzneimittel
GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Valproat-CT 600
mg Filmtabletten
Sodium Valproate 600 mg Gastro-resistant
tablet
Oral Use
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Natriumvalproat
Desitin retard 1000
mg
Sodium Valproate 1000 mg Prolonged-release
tablet
Oral Use
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Natriumvalproat
Desitin retard 150
mg
Sodium Valproate 150 mg Prolonged-release
tablet
Oral Use
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Natriumvalproat
Desitin retard 300
mg
Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 48/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Natriumvalproat
Desitin retard 500
mg
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 100mg/ml
Injektionslösung
Sodium Valproate 100 mg Solution for
injection
Intravenous Use
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 100mg/ml
Injektionslösung
Sodium Valproate 100 mg Solution for
injection
Intravenous Use
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 150 Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 49/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 200 mg Sodium Valproate 200 mg Gastro-resistant
tablet
Oral Use
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 300 Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 500 mg Sodium Valproate 500 mg Gastro-resistant
tablet
Oral Use
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 600 Sodium Valproate 600 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 50/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril long 1000
mg
Sodium Valproate 1000 mg Prolonged-release
tablet
Oral Use
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orifiril long 150 mg Sodium Valproate 150 mg Prolonged-release
capsule
Oral Use
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orifiril long 300 mg Sodium Valproate 300 mg Prolonged-release
capsule
Oral Use
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orifiril long 500 mg Sodium Valproate 500 mg Prolonged-release
capsule
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 51/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Saft Sodium Valproate 60 mg Oral solution Oral Use
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Saft Sodium Valproate 60 mg Oral solution Oral Use
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Valproat chrono
Desitin 300mg
Retardtabletten
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Valproat chrono
Desitin 500mg
Retardtabletten
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 52/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Dolorgiet GmbH &
Co.KG
Otto-von-Guericke-
Str. 1
53757 Sankt
Augustin
Germany
Leptilan 150mg Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Germany Dolorgiet GmbH &
Co.KG
Otto-von-Guericke-
Str. 1
53757 Sankt
Augustin
Germany
Leptilan 300mg Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Germany Dolorgiet GmbH &
Co.KG
Otto-von-Guericke-
Str. 1
53757 Sankt
Augustin
Germany
Leptilan 600mg Sodium Valproate 600 mg Gastro-resistant
tablet
Oral Use
Germany Dr. Lach Pharma
Consulting
Bahnhofstr. 6
79359 Riegel
Germany
Valproat-RPh
150mg
Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 53/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Dr. Lach Pharma
Consulting
Bahnhofstr. 6
79359 Riegel
Germany
Valproat-RPh
300mg
Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Germany Dr. Lach Pharma
Consulting
Bahnhofstr. 6
79359 Riegel
Germany
Valproat-RPh
600mg
Sodium Valproate 600 mg Gastro-resistant
tablet
Oral Use
Germany Dr. Lach Pharma
Consulting
Bahnhofstr. 6
79359 Riegel
Germany
Valproat-RPh
Lösung
Sodium Valproate 300 mg Oral solution Oral Use
Germany G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 300 mg
Retardtabletten
Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
Germany G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 500 mg
Retardtabletten
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 54/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Heumann Pharma
GmbH & Co.
Generica KG
Südwestpark 50
90449 Nürnberg
Germany
Valproat Heumann
150 mg
magensaftresistent
e Tabletten
Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Germany Heumann Pharma
GmbH & Co.
Generica KG
Südwestpark 50
90449 Nürnberg
Germany
Valproat Heumann
300 mg
magensaftresistent
e Tabletten
Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Germany Heumann Pharma
GmbH & Co.
Generica KG
Südwestpark 50
90449 Nürnberg
Germany
Valproat Heumann
600 mg
magensaftresistent
e Tabletten
Sodium Valproate 600 mg Gastro-resistant
tablet
Oral Use
Germany Heumann Pharma
GmbH & Co.
Generica KG
Südwestpark 50
90449 Nürnberg
Germany
Valproat heumann
chrono 300 mg
Retardtabletten
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 55/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Heumann Pharma
GmbH & Co.
Generica KG
Südwestpark 50
90449 Nürnberg
Germany
Valproat heumann
chrono 500 mg
Retardtabletten
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Germany Hexal
Aktiengesellschaft
Industriestr. 25
83607 Hozkirchen
Germany
Valproat HEXAL
150mg
Filmtabletten
Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Germany Hexal
Aktiengesellschaft
Industriestr. 25
83607 Hozkirchen
Germany
Valproat HEXAL
300mg
Filmtabletten
Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Germany Hexal
Aktiengesellschaft
Industriestr. 25
83607 Hozkirchen
Germany
Valproat HEXAL
300mg/ml Lösung
Sodium Valproate 300 mg Oral solution Oral Use
Germany Hexal
Aktiengesellschaft
Industriestr. 25
83607 Hozkirchen
Germany
Valproat HEXAL
600mg
Filmtabletten
Sodium Valproate 600 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 56/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Hexal
Aktiengesellschaft
Industriestr. 25
83607 Hozkirchen
Germany
Valproat Hexal
chrono 300 mg
Retardtabletten
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany Hexal
Aktiengesellschaft
Industriestr. 25
83607 Hozkirchen
Germany
Valproat HEXAL
chrono 300 mg
Retardtabletten
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany Hexal
Aktiengesellschaft
Industriestr. 25
83607 Hozkirchen
Germany
Valproat HEXAL
chrono 500 mg
Retardtabletten
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Germany Hexal
Aktiengesellschaft
Industriestr. 25
83607 Hozkirchen
Germany
Valproat HEXAL
chrono 500 mg
Retardtabletten
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 57/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany IIP - Institut für
industrielle
Pharmazie
Forschungs- und
Entwicklungsgesellsc
haft mbH
Benzstr. 2a
63741
Aschaffenburg
Germany
Valberg PR 300 mg Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany IIP - Institut für
industrielle
Pharmazie
Forschungs- und
Entwicklungsgesellsc
haft mbH
Benzstr. 2a
63741
Aschaffenburg
Germany
Valberg PR 500 mg Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 58/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany IIP - Institut für
industrielle
Pharmazie
Forschungs- und
Entwicklungsgesellsc
haft mbH
Benzstr. 2a
63741
Aschaffenburg
Germany
Valhel PR 300 mg Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany IIP - Institut für
industrielle
Pharmazie
Forschungs- und
Entwicklungsgesellsc
haft mbH
Benzstr. 2a
63741
Aschaffenburg
Germany
Valhel PR 500 mg Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Germany Lundbeck GmbH
Ericusspitze 2
20457 Hamburg
Germany
CONVULEX 150 Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Germany Lundbeck GmbH
Ericusspitze 2
20457 Hamburg
Germany
Convulex 300 Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 59/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Lundbeck GmbH
Ericusspitze 2
20457 Hamburg
Germany
Convulex 500 Sodium Valproate 500 mg Gastro-resistant
tablet
Oral Use
Germany Lundbeck GmbH
Ericusspitze 2
20457 Hamburg
Germany
Convulex
Tropflösung
Sodium Valproate 300 mg Oral solution Oral Use
Germany Mylan dura GmbH
Wittichstr. 6
64295 Darmstadt
Germany
valprodura 150mg Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Germany Mylan dura GmbH
Wittichstr. 6
64295 Darmstadt
Germany
valprodura 300 mg Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Germany Mylan dura GmbH
Wittichstr. 6
64295 Darmstadt
Germany
valprodura 600 mg Sodium Valproate 600 mg Gastro-resistant
tablet
Oral Use
Germany Neuraxpharm
Arzneimittel GmbH
Elisabeth-Selbert-
Str. 23
40764 Langelfeld
Germany
Valproat-
neuraxpharm
Sodium Valproate 300 mg Oral solution Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 60/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Neuraxpharm
Arzneimittel GmbH
Elisabeth-Selbert-
Str. 23
40764 Langelfeld
Germany
Valproat-
neuraxpharm
150 mg
Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Germany Neuraxpharm
Arzneimittel GmbH
Elisabeth-Selbert-
Str. 23
40764 Langelfeld
Germany
Valproat-
neuraxpharm
300 mg
Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Germany Neuraxpharm
Arzneimittel GmbH
Elisabeth-Selbert-
Str. 23
40764 Langelfeld
Germany
Valproat-
neuraxpharm
60 mg/ml
Lösung zum
Einnehmen
Sodium Valproate 60 mg Oral solution Oral Use
Germany Neuraxpharm
Arzneimittel GmbH
Elisabeth-Selbert-
Str. 23
40764 Langelfeld
Germany
Valproat-
neuraxpharm
600 mg
Sodium Valproate 600 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 61/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Neuraxpharm
Arzneimittel GmbH
Elisabeth-Selbert-
Str. 23
40764 Langelfeld
Germany
Valproat-
neuraxpharm
chrono 300 mg
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany Neuraxpharm
Arzneimittel GmbH
Elisabeth-Selbert-
Str. 23
40764 Langelfeld
Germany
Valproat-
neuraxpharm
chrono 300 mg
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany Neuraxpharm
Arzneimittel GmbH
Elisabeth-Selbert-
Str. 23
40764 Langelfeld
Germany
Valproat-
neuraxpharm
chrono 500 mg
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Germany Neuraxpharm
Arzneimittel GmbH
Elisabeth-Selbert-
Str. 23
40764 Langelfeld
Germany
Valproat-
neuraxpharm
chrono 500 mg
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Germany Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Valproat Orion 300
mg Retardtabletten
Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 62/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Valproat Orion 500
mg Retardtabletten
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Germany Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Valproat-
ratiopharm chrono
300 mg
Retardtabletten
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Valproat-
ratiopharm chrono
500 mg
Retardtabletten
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Germany Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Valproinsäure-
ratiopharm 150
Filmtabletten
Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Germany Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Valproinsäure-
ratiopharm 300
Filmtabletten
Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Germany Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Valproinsäure-
ratiopharm 600
Filmtabletten
Sodium Valproate 600 mg Gastro-resistant
tablet
Oral Use
Germany Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Valproinsäure-
ratiopharm Lösung
Sodium Valproate 300 mg Oral solution Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 63/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Sanofi-Aventis
Deutschland GmbH
Industriepark
Höchst, Gebäude
K703
65926 Frankfurt am
Main
Germany
Ergenyl 150 mg Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Germany Sanofi-Aventis
Deutschland GmbH
Industriepark
Höchst, Gebäude
K703
65926 Frankfurt am
Main
Germany
Ergenyl 300 mg Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Germany Sanofi-Aventis
Deutschland GmbH
Industriepark
Höchst, Gebäude
K703
65926 Frankfurt am
Main
Germany
Ergenyl 500 mg Sodium Valproate 500 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 64/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Sanofi-Aventis
Deutschland GmbH
Industriepark
Höchst, Gebäude
K703
65926 Frankfurt am
Main
Germany
Ergenyl chrono
300mg
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany Sanofi-Aventis
Deutschland GmbH
Industriepark
Höchst, Gebäude
K703
65926 Frankfurt am
Main
Germany
Ergenyl chrono
500mg
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Germany Sanofi-Aventis
Deutschland GmbH
Industriepark
Höchst, Gebäude
K703
65926 Frankfurt am
Main
Germany
Ergenyl
Chronosphere 100
mg Retardgranulat
Sodium valproate,
Valproic acid
66.66 mg,
29.03 mg
Prolonged-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 65/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Sanofi-Aventis
Deutschland GmbH
Industriepark
Höchst, Gebäude
K703
65926 Frankfurt am
Main
Germany
Ergenyl
Chronosphere 1000
mg Retardgranulat
Sodium valproate,
Valproic acid
666.6 mg,
290.27 mg
Prolonged-release
granules
Oral Use
Germany Sanofi-Aventis
Deutschland GmbH
Industriepark
Höchst, Gebäude
K703
65926 Frankfurt am
Main
Germany
Ergenyl
Chronosphere 250
mg Retardgranulat
Sodium valproate,
Valproic acid
166.76 mg,
72.61 mg
Prolonged-release
granules
Oral Use
Germany Sanofi-Aventis
Deutschland GmbH
Industriepark
Höchst, Gebäude
K703
65926 Frankfurt am
Main
Germany
Ergenyl
Chronosphere 50
mg Retardgranulat
Sodium valproate,
Valproic acid
33.33 mg,
14.51 mg
Prolonged-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 66/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Sanofi-Aventis
Deutschland GmbH
Industriepark
Höchst, Gebäude
K703
65926 Frankfurt am
Main
Germany
Ergenyl
Chronosphere 500
mg Retardgranulat
Sodium valproate,
Valproic acid
333.3 mg,
145.14 mg
Prolonged-release
granules
Oral Use
Germany Sanofi-Aventis
Deutschland GmbH
Industriepark
Höchst, Gebäude
K703
65926 Frankfurt am
Main
Germany
Ergenyl
Chronosphere 750
mg Retardgranulat
Sodium valproate,
Valproic acid
500.06 mg,
217.75 mg
Prolonged-release
granules
Oral Use
Germany Sanofi-Aventis
Deutschland GmbH
Industriepark
Höchst, Gebäude
K703
65926 Frankfurt am
Main
Germany
Ergenyl intravenös Sodium Valproate 400 mg Solution for
injection
Intravenous Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 67/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany Sanofi-Aventis
Deutschland GmbH
Industriepark
Höchst, Gebäude
K703
65926 Frankfurt am
Main
Germany
Ergenyl Lösung Sodium Valproate 300 mg Oral solution Oral Use
Germany Sanofi-Aventis
Deutschland GmbH
Industriepark
Höchst, Gebäude
K703
65926 Frankfurt am
Main
Germany
Ergenyl vial Sodium Valproate 400 mg Powder and solution
for solution for
injection
Intravenous Use
Germany Stadapharm GmbH
Stadastr 2-18
61118 Bad Vilbel
Germany
Valproat STADA
300 mg
Retardtabletten
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany Stadapharm GmbH
Stadastr 2-18
61118 Bad Vilbel
Germany
Valproat STADA
500 mg
Retardtabletten
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 68/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany TAD Pharma GmbH
Heinz-Lohmann-Str.
5
27472 Cuxhaven
Germany
Valpro TAD 150mg Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Germany TAD Pharma GmbH
Heinz-Lohmann-Str.
5
27472 Cuxhaven
Germany
Valpro TAD 300mg Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Germany TAD Pharma GmbH
Heinz-Lohmann-Str.
5
27472 Cuxhaven
Germany
Valpro TAD 600mg Sodium Valproate 600 mg Gastro-resistant
tablet
Oral Use
Germany TAD Pharma GmbH
Heinz-Lohmann-Str.
5
27472 Cuxhaven
Germany
Valpro TAD chrono
300mg
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany TAD Pharma GmbH
Heinz-Lohmann-Str.
5
27472 Cuxhaven
Germany
Valpro TAD chrono
500mg
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 69/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Germany TAD Pharma GmbH
Heinz-Lohmann-Str.
5
27472 Cuxhaven
Germany
Valpro TAD Lösung Sodium Valproate 300 mg Oral solution Oral Use
Germany TEVA GmbH
Graf-Arco-Str. 3
89079 Ulm
Germany
Convulsofin
Tabletten
calcium divalproate 333 mg Tablet Oral Use
Germany Winthrop
Arzneimittel GmbH
Brüningstr. 50
65926 Frankurt am
main
Germany
Valproat Chrono
Winthrop 300 mg
Retardtabletten
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Germany Winthrop
Arzneimittel GmbH
Brüningstr. 50
65926 Frankurt am
main
Germany
Valproat Chrono
Winthrop 500 mg
Retardtabletten
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Greece Sanofi-Aventis AEBE
348 Syngrou
Avenue, Building A'
17674 Kallithea
Greece
DEPAKINE CHRONO Sodium valproate,
Valproic acid
500 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 70/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Greece Sanofi-Aventis AEBE
348 Syngrou
Avenue, Building A'
17674 Kallithea
Greece
DEPAKINE CHRONO
(SPHERE)
Sodium valproate,
Valproic acid
100 mg/sachet Coated granules in
sachet
Oral Use
Greece Sanofi-Aventis AEBE
348 Syngrou
Avenue, Building A'
17674 Kallithea
Greece
DEPAKINE CHRONO
(SPHERE)
Sodium valproate,
Valproic acid
250 mg/sachet Coated granules in
sachet
Oral Use
Greece Sanofi-Aventis AEBE
348 Syngrou
Avenue, Building A'
17674 Kallithea
Greece
DEPAKINE CHRONO
(SPHERE)
Sodium valproate,
Valproic acid
500 mg/sachet Coated granules in
sachet
Oral Use
Greece Sanofi-Aventis AEBE
348 Syngrou
Avenue, Building A'
17674 Kallithea
Greece
DEPAKINE CHRONO
(SPHERE)
Sodium valproate,
Valproic acid
750 mg/sachet Coated granules in
sachet
Oral Use
Greece Sanofi-Aventis AEBE
348 Syngrou
Avenue, Building A'
17674 Kallithea
Greece
DEPAKINE CHRONO
(SPHERE)
Sodium valproate,
Valproic acid
1000
mg/sachet
Coated granules in
sachet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 71/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Greece Sanofi-Aventis AEBE
348 Syngrou
Avenue, Building A'
17674 Kallithea
Greece
DEPAKINE Sodium Valproate 500 mg/sachet Gastro-resistant
tablet
Oral Use
Greece Sanofi-Aventis AEBE
348 Syngrou
Avenue, Building A'
17674 Kallithea
Greece
DEPAKINE Sodium Valproate 200 mg/ml Oral solution Oral Use
Greece Sanofi-Aventis AEBE
348 Syngrou
Avenue, Building A'
17674 Kallithea
Greece
DEPAKINE Sodium Valproate 200 mg/tab Gastro-resistant
tablet
Oral Use
Greece Sanofi-Aventis AEBE
348 Syngrou
Avenue, Building A'
17674 Kallithea
Greece
DEPAKINE Sodium Valproate 400 mg/vial Powder and solvent
for solution for
injection
Intravenous Use
Greece DEMO ABEE
21st Km Athens-
Lamias National
Highway
14568 Kryoneri
Greece
HEXAQUIN Sodium Valproate 400 mg/vial Powder and solvent
for solution for
injection/infusion
Intravenous Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 72/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Hungary G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
CONVULEX 100
mg/ml oldatos
injekció
Valproic acid 100 mg/ml Solution for
injection
Intravenous Use
Hungary G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
CONVULEX 150 mg
gyomornedv-
ellenálló lágy
kapszula
Valproic acid 150 mg Gastro-resistant
capsule, soft
Oral Use
Hungary G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
CONVULEX 300 mg
gyomornedv-
ellenálló lágy
kapszula
Valproic acid 300 mg Gastro-resistant
capsule, soft
Oral Use
Hungary G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
CONVULEX 300 mg
retard filmtabletta
Valproic acid 300 mg prolonged release
film-coated tablet
Oral Use
Hungary G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
CONVULEX 50
mg/ml szirup
gyermekeknek
Valproic acid 50 mg/ml Syrup Oral Use
Hungary G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
CONVULEX 500 mg
gyomornedv-
ellenálló lágy
kapszula
Valproic acid 500 mg Gastro-resistant
capsule, soft
Oral Use
Hungary G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
CONVULEX 500 mg
retard filmtabletta
Valproic acid 500 mg prolonged release
film-coated tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 73/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Hungary Sanofi-Aventis zrt.
Tó u. 5.
H-1045 Budapest
Hungary
DEPAKINE 100
mg/ml por és
oldószer oldatos
injekcióhoz
Valproic acid 100 mg/ml Powder and solvent
for solution for
injection
Intravenous Use
Hungary Sanofi-Aventis zrt.
Tó u. 5.
H-1045 Budapest
Hungary
DEPAKINE 50
mg/ml szirup
Valproic acid 50 mg/ml Syrup Oral Use
Hungary Sanofi-Aventis zrt.
Tó u. 5.
H-1045 Budapest
Hungary
DEPAKINE CHRONO
300 mg filmtabletta
Valproic Acid,
Sodium Valproate
300 mg Film-coated tablet Oral Use
Hungary Sanofi-Aventis zrt.
Tó u. 5.
H-1045 Budapest
Hungary
DEPAKINE CHRONO
500 mg filmtabletta
Valproic Acid,
Sodium Valproate
500 mg Film-coated tablet Oral Use
Hungary Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL 300 mg
retard tabletta
Valproic acid 300 mg Prolonged-release
tablet
Oral Use
Iceland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 74/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Iceland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Sodium Valproate 600 mg Gastro-resistant
tablet
Oral Use
Iceland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Retard Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
Iceland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Sodium Valproate 60 mg/ml Oral solution Oral Use
Iceland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 75/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Ireland Sanofi-aventis
Ireland Ltd. T/A
SANOFI
Citywest Business
Campus
Dublin 24
Ireland
Epilim 100 mg
Crushable Tablets
Sodium Valproate 100 mg Tablet Oral Use
Ireland Sanofi-aventis
Ireland Ltd. T/A
SANOFI
Citywest Business
Campus
Dublin 24
Ireland
Epilim Enteric 200
mg gastro-resistant
coated tablets
Sodium Valproate 200 mg Gastro-resistant
tablet
Oral Use
Ireland Sanofi-aventis
Ireland Ltd. T/A
SANOFI
Citywest Business
Campus
Dublin 24
Ireland
Epilim Enteric
500mg Gastro-
resistant Coated
Tablets
Sodium Valproate 500 mg Gastro-resistant
tablet
Oral Use
Ireland Sanofi-aventis
Ireland Ltd. T/A
SANOFI
Citywest Business
Campus
Dublin 24
Ireland
Epilim
Chronosphere
100mg prolonged-
release granules
Sodium valproate,
Valproic acid
66.66 mg,
29.03 mg
Prolonged-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 76/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Ireland Sanofi-aventis
Ireland Ltd. T/A
SANOFI
Citywest Business
Campus
Dublin 24
Ireland
Epilim
Chronosphere
250mg prolonged-
release granules
Sodium valproate,
Valproic acid
166.76 mg,
72.61 mg
Prolonged-release
granules
Oral Use
Ireland Sanofi-aventis
Ireland Ltd. T/A
SANOFI
Citywest Business
Campus
Dublin 24
Ireland
Epilim
Chronosphere
500mg prolonged-
release granules
Sodium valproate,
Valproic acid
333.3 mg,
145.14 mg
Prolonged-release
granules
Oral Use
Ireland Sanofi-aventis
Ireland Ltd. T/A
SANOFI
Citywest Business
Campus
Dublin 24
Ireland
Epilim
Chronosphere
750mg prolonged-
release granules
Sodium valproate,
Valproic acid
500.06 mg,
217.75 mg
Prolonged-release
granules
Oral Use
Ireland Sanofi-aventis
Ireland Ltd. T/A
SANOFI
Citywest Business
Campus
Dublin 24
Ireland
Epilim
Chronosphere
1000mg prolonged-
release granules
Sodium valproate,
Valproic acid
666.6 mg,
290.27 mg
Prolonged-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 77/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Ireland Sanofi-aventis
Ireland Ltd. T/A
SANOFI
Citywest Business
Campus
Dublin 24
Ireland
Epilim Chrono
200mg Prolonged
Release Tablets
Sodium valproate,
Valproic acid
133.2 mg,
58 mg
Prolonged-release
tablet
Oral Use
Ireland Sanofi-aventis
Ireland Ltd. T/A
SANOFI
Citywest Business
Campus
Dublin 24
Ireland
Epilim Chrono
300mg Prolonged
Release Tablets
Sodium valproate,
Valproic acid
199.8 mg,
87 mg
Prolonged-release
tablet
Oral Use
Ireland Sanofi-aventis
Ireland Ltd. T/A
SANOFI
Citywest Business
Campus
Dublin 24
Ireland
Epilim Chrono
500mg Prolonged
Release Tablets.
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Ireland Sanofi-aventis
Ireland Ltd. T/A
SANOFI
Citywest Business
Campus
Dublin 24
Ireland
Epilim Intravenous
400 mg, powder
and solvent for
solution for
injection or
infusion.
Sodium Valproate 400 mg Powder and solvent
for solution for
injection/infusion
Intravenous Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 78/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Ireland Sanofi-aventis
Ireland Ltd. T/A
SANOFI
Citywest Business
Campus
Dublin 24
Ireland
Epilim Liquid
200mg/5ml Oral
Solution.
Sodium Valproate 200 mg Oral solution Oral Use
Ireland Sanofi-aventis
Ireland Ltd. T/A
SANOFI
Citywest Business
Campus
Dublin 24
Ireland
Epilim Syrup
200mg/5ml Oral
Solution.
Sodium Valproate 200 mg Oral solution Oral Use
Italy Sanofi-Aventis SpA
Viale Luigi Bodio,
37/B
20158 Milano
Italy
Depamide Valpromide 300 mg Gastro-resistant
tablet
Oral Use
Italy EG SpA
Via Scarlatti
Domenico, 31
20124 Milano
Italy
Acido valproico e
sodio valproato EG
Valproic Acid,
Sodium Valproate
200 mg sodium
valproate + 87
mg valproic
acid
(equivalent to
300 mg sodium
valproate)
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 79/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Italy EG SpA
Via Scarlatti
Domenico, 31
20124 Milano
Italy
Acido valproico e
sodio valproato EG
Valproic Acid,
Sodium Valproate
333 mg sodium
valproate +
145 mg
valproic acid
(equivalent to
500 mg sodium
valproate)
Prolonged-release
tablet
Oral Use
Italy Sanofi-Aventis
France SA
1-13 Boulevard
Romain Rolland
75014 PARIS
France
Depakin Chrono Valproic Acid,
Sodium Valproate
199,8 mg
sodium
valproate + 87
mg valproic
acid
(equivalent to
300 mg sodium
valproate)
Prolonged-release
tablet
Oral Use
Italy Sanofi-Aventis
France SA
1-13 Boulevard
Romain Rolland
75014 PARIS
France
Depakin Chrono Valproic Acid,
Sodium Valproate
333 mg sodium
valproate +
145 mg
valproic acid
(equivalent to
500 mg sodium
valproate)
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 80/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Italy Sandoz SpA
Largo Umberto
Boccioni, 1
21040 Milano
Italy
Acido Valproico
Sandoz
Sodium valproate /
Valproic acid
199,8 mg
sodium
valproate + 87
mg valproic
acid
(equivalent to
300 mg sodium
valproate)
Prolonged-release
tablet
Oral Use
Italy Sandoz SpA
Largo Umberto
Boccioni, 1
21040 Milano
Italy
Acido Valproico
Sandoz
Sodium valproate /
Valproic acid
333 mg sodium
valproate +
145 mg
valproic acid
(equivalent to
500 mg sodium
valproate)
Prolonged-release
tablet
Oral Use
Italy Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Acido Valproico e
Sodio Valproato
Ratiopharm
Sodium valproate /
Valproic acid
200 mg sodium
valproate + 87
mg valproic
acid
(equivalent to
300 mg sodium
valproate)
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 81/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Italy Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Acido Valproico e
Sodio Valproato
Ratiopharm
Sodium valproate /
Valproic acid
333 mg sodium
valproate +
145 mg
valproic acid
(equivalent to
500 mg sodium
valproate)
Prolonged-release
tablet
Oral Use
Italy Sanofi-Aventis
France SA
1-13 Boulevard
Romain Rolland
75014 PARIS
France
Depakin sodium valproate 200 mg Gastro-resistant
tablet
Oral Use
Italy Sanofi-Aventis
France SA
1-13 Boulevard
Romain Rolland
75014 PARIS
France
Depakin sodium valproate 500 mg Gastro-resistant
tablet
Oral Use
Italy Sanofi-Aventis
France SA
1-13 Boulevard
Romain Rolland
75014 PARIS
France
Depakin sodium valproate 200 mg/ml Oral solution Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 82/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Italy Sanofi-Aventis
France SA
1-13 Boulevard
Romain Rolland
75014 PARIS
France
Depakin sodium valproate 400 mg / 4 ml Powder and solvent
for solution for
infusion
Intravenous Use
Italy Sanofi-Aventis
France SA
1-13 Boulevard
Romain Rolland
75014 PARIS
France
Depakin Valproic Acid,
Sodium Valproate
33,33 mg
sodium
valproate +
14,51 mg
valproic acid
(equivalent to
50 mg sodium
valproate)
Modified-release
granules
Oral Use
Italy Sanofi-Aventis
France SA
1-13 Boulevard
Romain Rolland
75014 PARIS
France
Depakin Valproic Acid,
Sodium Valproate
66,66 mg
sodium
valproate +
29,03 mg
valproic acid
equivalent to
100 mg sodium
valproate
Modified-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 83/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Italy Sanofi-Aventis
France SA
1-13 Boulevard
Romain Rolland
75014 PARIS
France
Depakin Valproic Acid,
Sodium Valproate
166,76 mg
sodium
valproate +
72,61 mg
valproic acid
(equivalent to
250 mg sodium
valproate)
Modified-release
granules
Oral Use
Italy Sanofi-Aventis
France SA
1-13 Boulevard
Romain Rolland
75014 PARIS
France
Depakin Valproic Acid,
Sodium Valproate
333,30 mg
sodium
valproate +
145,14 mg
valproic acid
(equivalent to
500 mg sodium
valproate)
Modified-release
granules
Oral Use
Italy Sanofi-Aventis
France SA
1-13 Boulevard
Romain Rolland
75014 PARIS
France
Depakin Valproic Acid,
Sodium Valproate
500.06 mg
sodium
valproate +
217.75 mg
valproic acid
(equivalent to
750 mg sodium
valproate)
Modified-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 84/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Italy Sanofi-Aventis
France SA
1-13 Boulevard
Romain Rolland
75014 PARIS
France
Depakin Valproic Acid,
Sodium Valproate
666.60 mg
sodium
valproate +
290.27 mg
valproic acid
(equivalent to
1000 mg
sodium
valproate)
Modified-release
granules
Oral Use
Italy Zentiva Italia Srl
Viale Bodio 37/B
20158 Milano
Italy
Sodio Valproato
Zentiva
sodium valproate 200 mg Gastro-resistant
tablet
Oral Use
Italy Zentiva Italia Srl
Viale Bodio 37/B
20158 Milano
Italy
Sodio Valproato
Zentiva
sodium valproate 500 mg Gastro-resistant
tablet
Oral Use
Italy Zentiva Italia Srl
Viale Bodio 37/B
20158 Milano
Italy
Sodio Valproato
Zentiva
sodium valproate 200 mg/ml Oral solution Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 85/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Italy Zentiva Italia Srl
Viale Bodio 37/B
20158 Milano
Italy
Sodio Valproato
Zentiva
sodium valproate 199,8 mg
sodium
valproate + 87
mg valproic
acid
(equivalent to
300 mg sodium
valproate)
Prolonged-release
tablet
Oral Use
Italy Zentiva Italia Srl
Viale Bodio 37/B
20158 Milano
Italy
Sodio Valproato
Zentiva
sodium valproate 333 mg sodium
valproate +
145 mg
valproic acid
(equivalent to
500 mg sodium
valproate)
Prolonged-release
tablet
Oral Use
Italy Zentiva Italia Srl
Viale Bodio 37/B
20158 Milano
Italy
Sodio Valproato
Zentiva
sodium valproate 400 mg / 4 ml Powder and solvent
for solution for
infusion
Intravenous Use
Italy Sigma-Tau Industrie
Farmaceutiche
Riunite SpA
Viale Shakespeare,
47
00144 Roma
Italy
Depamag magnesium valproate 200 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 86/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Italy Sigma-Tau Industrie
Farmaceutiche
Riunite SpA
Viale Shakespeare,
47
00144 Roma
Italy
Depamag magnesium valproate 500 mg Gastro-resistant
tablet
Oral Use
Italy Sigma-Tau Industrie
Farmaceutiche
Riunite SpA
Viale Shakespeare,
47
00144 Roma
Italy
Depamag magnesium valproate 100 mg/ml Oral solution Oral Use
Latvia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex retard
300 mg prolonged
release tablets
sodium valproate 300 mg Prolonged-release
tablet
Oral Use
Latvia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex retard
500 mg prolonged
release tablets
sodium valproate 500 mg Prolonged-release
tablet
Oral Use
Latvia sanofi-aventis Latvia
SIA
Kr.Valdemara 33-8
Riga LV1010
Latvia
Depakine Chrono
300 mg slow-
release film-coated
tablets
Valproic Acid,
Sodium Valproate
300 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 87/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Latvia sanofi-aventis Latvia
SIA
Kr.Valdemara 33-8
Riga LV1010
Latvia
Depakine Chrono
500 mg slow-
release film-coated
tablets
Valproic Acid,
Sodium Valproate
500 mg Prolonged-release
tablet
Oral Use
Latvia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 100
mg/ml solution for
injection/concentra
te for solution for
infusion
sodium valproate 100 mg/ml Solution for
injection/infusion
Intravenous Use
Latvia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 50 mg/ml
syrup
sodium valproate 50 mg/ml Syrup Oral Use
Latvia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 300
mg/ml oral solution
sodium valproate 300 mg/ml Oral solution Oral Use
Latvia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 500 mg
gastro-resistant
capsules, soft
Valproic acid 500 mg Gastro-resistant
capsule, soft
Oral Use
Latvia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 150 mg
gastro-resistant
capsules, soft
Valproic acid 150 mg Gastro-resistant
capsule, soft
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 88/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Latvia G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 300 mg
gastro-resistant
capsules, soft
Valproic acid 300 mg Gastro-resistant
capsule, soft
Oral Use
Latvia sanofi-aventis Latvia
SIA
Kr.Valdemara 33-8
Riga LV1010
Latvia
Depakine 57,64
mg/ml syrup
sodium valproate 57.64 mg/ml Syrup Oral Use
Latvia Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor 300 mg
prolonged release
tablets
sodium valproate 300 mg Prolonged-release
tablet
Oral Use
Latvia Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor 500 mg
prolonged release
tablets
sodium valproate 500 mg Prolonged-release
tablet
Oral Use
Lithuania Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
Lithuania Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 89/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Lithuania G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Sodium Valproate 100 mg/ml Solution for
injection/infusion
Intravenous Use
Lithuania G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Valproic acid 150 mg Gastro-resistant
capsule, soft
Oral Use
Lithuania G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Valproic acid 300 mg Gastro-resistant
capsule, soft
Oral Use
Lithuania G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Valproic acid 500 mg Gastro-resistant
capsule, soft
Oral Use
Lithuania G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Sodium Valproate 50 mg/ml Syrup Oral Use
Lithuania G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Sodium Valproate 300 mg/ml Oral solution Oral Use
Lithuania G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex retard Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 90/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Lithuania G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex retard Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Lithuania UAB „SANOFI-
AVENTIS LIETUVA“
A. Juozapavičiaus g.
6/2
LT-09310 Vilnius
Lithuania
DEPAKINE Sodium Valproate 57.64 mg/ml Syrup Oral Use
Lithuania UAB „SANOFI-
AVENTIS LIETUVA“
A. Juozapavičiaus g.
6/2
LT-09310 Vilnius
Lithuania
DEPAKINE CHRONO Sodium Valproate 300 mg Modified-release
tablet
Oral Use
Lithuania UAB „SANOFI-
AVENTIS LIETUVA“
A. Juozapavičiaus g.
6/2
LT-09310 Vilnius
Lithuania
DEPAKINE CHRONO Sodium Valproate 500 mg Modified-release
tablet
Oral Use
Lithuania UAB „SANOFI-
AVENTIS LIETUVA“
A. Juozapavičiaus g.
6/2
LT-09310 Vilnius
Lithuania
DEPAKINE
Chronosphere
Sodium Valproate 250 mg Modified-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 91/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Lithuania UAB „SANOFI-
AVENTIS LIETUVA“
A. Juozapavičiaus g.
6/2
LT-09310 Vilnius
Lithuania
DEPAKINE
Chronosphere
Sodium Valproate 500 mg Modified-release
granules
Oral Use
Lithuania UAB „SANOFI-
AVENTIS LIETUVA“
A. Juozapavičiaus g.
6/2
LT-09310 Vilnius
Lithuania
DEPAKINE
Chronosphere
Sodium Valproate 750 mg Modified-release
granules
Oral Use
Lithuania UAB „SANOFI-
AVENTIS LIETUVA“
A. Juozapavičiaus g.
6/2
LT-09310 Vilnius
Lithuania
DEPAKINE
Chronosphere
Sodium Valproate 1000 mg Modified-release
granules
Oral Use
Lithuania Sandoz d.d.
Verovškova 57
SI-1000 Ljubljana
Slovenia
Valproate sodium
Sandoz
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Luxembourg Takeda Belgium
Chaussée de Gand
615
1080 Bruxelles
Belgium
Convulex gelule
gastro résistante
Valproic acid 300 mg Gastro-resistant
capsule
oral use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 92/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Luxembourg Takeda Belgium
Chaussée de Gand
615
1080 Bruxelles
Belgium
Convulex gelule
gastro résistante
Valproic acid 500 mg Gastro-resistant
capsule
oral use
Luxembourg Mylan BVBA/SPRL
Terhulpsesteenweg 6
box A
1560 Hoeilaart
Belgium
Convulex comprimé
gastro résistant
sodium valproate 300 mg Gastro-resistant
tablet
oral use
Luxembourg Mylan BVBA/SPRL
Terhulpsesteenweg 6
box A
1560 Hoeilaart
Belgium
Convulex comprimé
gastro résistant
sodium valproate 500 mg Gastro-resistant
tablet
oral use
Luxembourg Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine solution sodium valproate 300 mg/ml Oral drops, solution oral use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 93/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Luxembourg Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine sirop sodium valproate 300 mg / 5 ml Syrup oral use
Luxembourg Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine enteric sodium valproate 150 mg Gastro-resistant
tablet
oral use
Luxembourg Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine enteric sodium valproate 300 mg Gastro-resistant
tablet
oral use
Luxembourg Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine enteric sodium valproate 500 mg Gastro-resistant
tablet
oral use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 94/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Luxembourg Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine chrono Sodium valproate,
Valproic acid
200 mg,
87 mg
Prolonged-release
tablet
oral use
Luxembourg Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine chrono Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
oral use
Luxembourg Sanofi Belgium N.V.
Airport Plaza,
Montreal Building
Leonardo Da
Vincilaan 19
1831 Diegem
Belgium
Depakine I.V. sodium valproate 400 mg / 4 ml Powder and solvent
for solution for
injection
Intravenous Use
Luxembourg Hexal AG
Industriestrasse 25
83067 Holzkirchen
Germany
Valproat Hexal
chrono
Sodium valproate,
Valproic acid
200 mg,
87 mg
Prolonged-release
tablet
oral use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 95/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Luxembourg Hexal AG
Industriestrasse 25
83067 Holzkirchen
Germany
Valproat Hexal
chrono
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
oral use
Luxembourg Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Valproat-
ratiopharm chrono
Sodium valproate,
Valproic acid
200 mg,
87 mg
Prolonged-release
tablet
Oral Use
Luxembourg Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Valproat-
ratiopharm chrono
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Luxembourg Eurogenerics SA
Esplanade Heysel
b22
1020 Bruxelles
Belgium
Valproate Retard
EG
Sodium valproate,
Valproic acid
200 mg,
87 mg
Prolonged-release
tablet
oral use
Luxembourg Eurogenerics SA
Esplanade Heysel
b22
1020 Bruxelles
Belgium
Valproate Retard
EG
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
oral use
Malta Sanofi-Aventis Malta
Ltd.
Triq Kan. K. Pirotta
Birkirkara BKR 1114
Malta
Epilim Chrono 200
controlled release
tab
Sodium Valproate 200 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 96/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Malta Sanofi-Aventis Malta
Ltd.
Triq Kan. K. Pirotta
Birkirkara BKR 1114
Malta
Epilim Chrono 500
controlled release
tab
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Malta Sanofi-Aventis Malta
Ltd.
Triq Kan. K. Pirotta
Birkirkara BKR 1114
Malta
Epilim Chrono 300
controlled release
tab
Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
Malta Sanofi-Aventis Malta
Ltd.
Triq Kan. K. Pirotta
Birkirkara BKR 1114
Malta
Epilim Liquid
200mg/5ml
Sodium Valproate 200 mg / 5 ml Oral solution Oral Use
Norway Desitin Arzneimittel
GmbH
Postfach 630164
D-22311 HAMBURG
Deutschland
Orifril retard Sodium valproate 300 mg Prolonged-release
tablet
Oral Use
Norway Desitin Arzneimittel
GmbH
Postfach 630164
D-22311 HAMBURG
Deutschland
Orifril long Sodium valproate 1000 mg Prolonged-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 97/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Norway Desitin Arzneimittel
GmbH
Postfach 630164
D-22311 HAMBURG
Deutschland
Orifril long Sodium valproate 500 mg Prolonged-release
granules
Oral Use
Norway Desitin Arzneimittel
GmbH
Postfach 630164
D-22311 HAMBURG
Deutschland
Orifril long Sodium valproate 150 mg Prolonged-release
capsule
Oral Use
Norway Desitin Arzneimittel
GmbH
Postfach 630164
D-22311 HAMBURG
Deutschland
Orifril long Sodium valproate 300 mg Prolonged-release
capsule
Oral Use
Norway Desitin Arzneimittel
GmbH
Postfach 630164
D-22311 HAMBURG
Deutschland
Orifril Sodium valproate 100 mg/ml Solution for
injection
Oral Use
Norway Desitin Arzneimittel
GmbH
Postfach 630164
D-22311 HAMBURG
Deutschland
Orifril Sodium valproate 60 mg/ml Oral solution Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 98/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Norway Desitin Arzneimittel
GmbH
Postfach 630164
D-22311 HAMBURG
Deutschland
Orifril Sodium valproate 300 mg Gastro-resistant
tablet
Oral Use
Norway Desitin Arzneimittel
GmbH
Postfach 630164
D-22311 HAMBURG
Deutschland
Orifril Sodium valproate 600 mg Gastro-resistant
tablet
Oral Use
Norway Desitin Arzneimittel
GmbH
Postfach 630164
D-22311 HAMBURG
Deutschland
Orifril Sodium valproate 150 mg Gastro-resistant
tablet
Oral Use
Poland Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
Poland Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Poland G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convival Chrono Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 99/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Poland G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Valproic acid 500 mg Capsule, soft Oral Use
Poland G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Sodium Valproate 50 mg/ml Syrup Oral Use
Poland G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 150 Valproic acid 150 mg Capsule, soft Oral Use
Poland G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 300 Valproic acid 300 mg Capsule, soft Oral Use
Poland SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
Depakine Sodium Valproate 288.2 mg / 5
ml
Syrup Oral Use
Poland SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
Depakine Sodium Valproate 400 mg Powder and solvent
for solution for
injection
Intravenous Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 100/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Poland Sanofi-Aventis Sp. z
o.o.
17 Bonifraterska Str.
00-203 Warsaw
Poland
Depakine Chrono
300
Sodium valproate,
Valproic acid
200 mg,
87 mg
Prolonged-release
tablet
Oral Use
Poland Sanofi-Aventis Sp. z
o.o.
17 Bonifraterska Str.
00-203 Warsaw
Poland
Depakine Chrono
500
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
Poland Sanofi-Aventis Sp. z
o.o.
17 Bonifraterska Str.
00-203 Warsaw
Poland
Depakine
Chronosphere 100
Sodium valproate,
Valproic acid
(66,66 mg +
29,03
mg)/sachet
Prolonged-release
granules
Oral Use
Poland Sanofi-Aventis Sp. z
o.o.
17 Bonifraterska Str.
00-203 Warsaw
Poland
Depakine
Chronosphere 1000
Sodium valproate,
Valproic acid
(666,60 mg +
290,27
mg)/sachet
Prolonged-release
granules
Oral Use
Poland Sanofi-Aventis Sp. z
o.o.
17 Bonifraterska Str.
00-203 Warsaw
Poland
Depakine
Chronosphere 250
Sodium valproate,
Valproic acid
(166,76 mg +
72,61
mg)/sachet
Prolonged-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 101/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Poland Sanofi-Aventis Sp. z
o.o.
17 Bonifraterska Str.
00-203 Warsaw
Poland
Depakine
Chronosphere 500
Sodium valproate,
Valproic acid
(333,30 mg +
145,14
mg)/sachet
Prolonged-release
granules
Oral Use
Poland Sanofi-Aventis Sp. z
o.o.
17 Bonifraterska Str.
00-203 Warsaw
Poland
Depakine
Chronosphere 750
Sodium valproate,
Valproic acid
(500,06 mg +
217,75
mg)/sachet
Prolonged-release
granules
Oral Use
Poland PharmaSwiss Ceska
Republika s.r.o.
1569/2c Jankovcova
Praha 7
PSC 170 00
Holesovice
Czech Republic
Dipromal Magnesium Valproate 200 mg Film-coated tablet Oral Use
Poland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Sodium Valproate 60 mg/ml Oral solution Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 102/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Poland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 150 Sodium Valproate 150 mg Gastro-resistant
tablet
Oral Use
Poland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 300 Sodium Valproate 300 mg Gastro-resistant
tablet
Oral Use
Poland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 300 retard Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
Poland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 600 Sodium Valproate 600 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 103/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Poland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Long 1000 Sodium Valproate 1000 mg Prolonged-release
tablet
Oral Use
Poland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Long 150 Sodium Valproate 150 mg Prolonged-release
capsule
Oral Use
Poland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Long 300 Sodium Valproate 300 mg Prolonged-release
capsule
Oral Use
Poland Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril Long 500 Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Poland Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
ValproLEK 300 Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 104/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Poland Sandoz GmbH
Biochemiestrasse 10
6250 Kundl
Austria
ValproLEK 500 Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Portugal Sanofi - Produtos
Farmacêuticos, Lda.
Empreendimento
Lagoas Park Edifício
7, 3º Piso, Porto
Salvo
2740-244 Porto
Salvo
Portugal
Depakine Valproic acid 200 mg/ml Oral solution Oral Use
Portugal Sanofi - Produtos
Farmacêuticos, Lda.
Empreendimento
Lagoas Park Edifício
7, 3º Piso, Porto
Salvo
2740-244 Porto
Salvo
Portugal
Depakine Valproic acid 400 mg / 4 ml Powder and solvent
for solution for
injection
Intravenous Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 105/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Portugal Sanofi - Produtos
Farmacêuticos, Lda.
Empreendimento
Lagoas Park Edifício
7, 3º Piso, Porto
Salvo
2740-244 Porto
Salvo
Portugal
Depakine Valproic acid 40 mg/ml Syrup Oral Use
Portugal Sanofi - Produtos
Farmacêuticos, Lda.
Empreendimento
Lagoas Park Edifício
7, 3º Piso, Porto
Salvo
2740-244 Porto
Salvo
Portugal
Depakine Chrono
300
Valproic acid 300 mg Prolonged-release
tablet
Oral Use
Portugal Sanofi - Produtos
Farmacêuticos, Lda.
Empreendimento
Lagoas Park Edifício
7, 3º Piso, Porto
Salvo
2740-244 Porto
Salvo
Portugal
Depakine Chrono
500
Valproic acid 500 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 106/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Portugal Sanofi - Produtos
Farmacêuticos, Lda.
Empreendimento
Lagoas Park Edifício
7, 3º Piso, Porto
Salvo
2740-244 Porto
Salvo
Portugal
Depakine
Chronosphere
Valproic acid 750 mg Modified-release
granules
Oral Use
Portugal Sanofi - Produtos
Farmacêuticos, Lda.
Empreendimento
Lagoas Park Edifício
7, 3º Piso, Porto
Salvo
2740-244 Porto
Salvo
Portugal
Depakine
Chronosphere
Valproic acid 50 mg Modified-release
granules
Oral Use
Portugal Sanofi - Produtos
Farmacêuticos, Lda.
Empreendimento
Lagoas Park Edifício
7, 3º Piso, Porto
Salvo
2740-244 Porto
Salvo
Portugal
Depakine
Chronosphere
Valproic acid 500-1000 mg Modified-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 107/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Portugal Sanofi - Produtos
Farmacêuticos, Lda.
Empreendimento
Lagoas Park Edifício
7, 3º Piso, Porto
Salvo
2740-244 Porto
Salvo
Portugal
Depakine
Chronosphere
Valproic acid 1000 mg Modified-release
granules
Oral Use
Portugal Sanofi - Produtos
Farmacêuticos, Lda.
Empreendimento
Lagoas Park Edifício
7, 3º Piso, Porto
Salvo
2740-244 Porto
Salvo
Portugal
Depakine
Chronosphere
Valproic acid 100 mg Modified-release
granules
Oral Use
Portugal Sanofi - Produtos
Farmacêuticos, Lda.
Empreendimento
Lagoas Park Edifício
7, 3º Piso, Porto
Salvo
2740-244 Porto
Salvo
Portugal
Depakine
Chronosphere
Valproic acid 50-350 mg Modified-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 108/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Portugal Sanofi - Produtos
Farmacêuticos, Lda.
Empreendimento
Lagoas Park Edifício
7, 3º Piso, Porto
Salvo
2740-244 Porto
Salvo
Portugal
Depakine
Chronosphere
Valproic acid 250 mg Modified-release
granules
Oral Use
Portugal Sanofi - Produtos
Farmacêuticos, Lda.
Empreendimento
Lagoas Park Edifício
7, 3º Piso, Porto
Salvo
2740-244 Porto
Salvo
Portugal
Depakine
Chronosphere
Valproic acid 500 mg Modified-release
granules
Oral Use
Portugal Tecnifar - Indústria
Técnica
Farmacêutica, S.A.
Rua Tierno Galvan -
Amoreiras - Torre 3
- 12º Lisboa
1099-036 Lisboa
Portugal
Diplexil Valproic acid 200 mg Coated tablet Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 109/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Portugal Tecnifar - Indústria
Técnica
Farmacêutica, S.A.
Rua Tierno Galvan -
Amoreiras - Torre 3
- 12º Lisboa
1099-036 Lisboa
Portugal
Diplexil Valproic acid 200 mg/ml Oral solution Oral Use
Portugal Tecnifar - Indústria
Técnica
Farmacêutica, S.A.
Rua Tierno Galvan -
Amoreiras - Torre 3
- 12º Lisboa
1099-036 Lisboa
Portugal
Diplexil Valproic acid 100 mg/ml Solution for
injection
Intravenous Use
Portugal Tecnifar - Indústria
Técnica
Farmacêutica, S.A.
Rua Tierno Galvan -
Amoreiras - Torre 3
- 12º Lisboa
1099-036 Lisboa
Portugal
Diplexil Valproic acid 500 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 110/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Portugal Tecnifar - Indústria
Técnica
Farmacêutica, S.A.
Rua Tierno Galvan -
Amoreiras - Torre 3
- 12º Lisboa
1099-036 Lisboa
Portugal
Diplexil 1000 Valproic acid 1000 mg Prolonged-release
granules
Oral Use
Portugal Tecnifar - Indústria
Técnica
Farmacêutica, S.A.
Rua Tierno Galvan -
Amoreiras - Torre 3
- 12º Lisboa
1099-036 Lisboa
Portugal
Diplexil 150 Valproic acid 150 mg Prolonged-release
capsule, hard
Oral Use
Portugal Tecnifar - Indústria
Técnica
Farmacêutica, S.A.
Rua Tierno Galvan -
Amoreiras - Torre 3
- 12º Lisboa
1099-036 Lisboa
Portugal
Diplexil 300 Valproic acid 300 mg Prolonged-release
capsule, hard
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 111/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Portugal Tecnifar - Indústria
Técnica
Farmacêutica, S.A.
Rua Tierno Galvan -
Amoreiras - Torre 3
- 12º Lisboa
1099-036 Lisboa
Portugal
Diplexil 500 Valproic acid 500 mg Prolonged-release
granules
Oral Use
Portugal Tecnifar - Indústria
Técnica
Farmacêutica, S.A.
Rua Tierno Galvan -
Amoreiras - Torre 3
- 12º Lisboa
1099-036 Lisboa
Portugal
Diplexil-R Valproate Semisodium 500 mg Coated tablet Oral Use
Portugal Tecnifar - Indústria
Técnica
Farmacêutica, S.A.
Rua Tierno Galvan -
Amoreiras - Torre 3
- 12º Lisboa
1099-036 Lisboa
Portugal
Diplexil-R Valproate Semisodium 250 mg Coated tablet Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 112/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Portugal Generis
Farmacêutica, S.A.
Rua João de Deus,
19 Amadora
2700-487 Amadora
Portugal
Ácido Valpróico
Generis
Valproic acid 400 mg / 4 ml Powder and solvent
for solution for
injection
Intravenous Use
Portugal Generis
Farmacêutica, S.A.
Rua João de Deus,
19 Amadora
2700-487 Amadora
Portugal
Ácido Valpróico
Generis
Valproic acid 300 mg Prolonged-release
tablet
Oral Use
Portugal Generis
Farmacêutica, S.A.
Rua João de Deus,
19 Amadora
2700-487 Amadora
Portugal
Ácido Valpróico
Generis
Valproic acid 500 mg Prolonged-release
tablet
Oral Use
Portugal Ratiopharm -
Comércio e Indústria
de Produtos
Farmacêuticos, Lda
Rua Quinta do
Pinheiro - Edifício
Tejo - 6º Piso
Carnaxide
2790-143 Carnaxide
Portugal
Ácido Valpróico
Ratiopharm 300 mg
Comprimidos de
libertação
prolongada
Valproic acid 300 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 113/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Portugal Ratiopharm -
Comércio e Indústria
de Produtos
Farmacêuticos, Lda
Rua Quinta do
Pinheiro - Edifício
Tejo - 6º Piso
Carnaxide
2790-143 Carnaxide
Portugal
Ácido Valpróico
Ratiopharm 500 mg
Comprimidos de
libertação
prolongada
Valproic acid 500 mg Prolonged-release
tablet
Oral Use
Portugal Sandoz
Farmacêutica, Lda.
Alameda da Beloura,
Edifício 1, 2º -
Escritório 15 Sintra
2710-693 Sintra
Portugal
Ácido Valpróico
Sandoz 300 mg
Comprimidos de
libertação
prolongada
Valproic acid 300 mg Prolonged-release
tablet
Oral Use
Portugal Sandoz
Farmacêutica, Lda.
Alameda da Beloura,
Edifício 1, 2º -
Escritório 15 Sintra
2710-693 Sintra
Portugal
Ácido Valpróico
Sandoz 500 mg
Comprimidos de
libertação
prolongada
Valproic acid 500 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 114/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Romania GEROT
PHARMAZEUTIKA
Ges.m.b.H.
Arnethgasse 3
A-1160, Wien
Austria
CONVULEX® 150
mg
Valproic Acid,
Sodium Valproate
150 mg Gastro-resistant
capsule, soft
Oral Use
Romania GEROT
PHARMAZEUTIKA
Ges.m.b.H.
Arnethgasse 3
A-1160, Wien
Austria
CONVULEX® 300
mg
Valproic Acid,
Sodium Valproate
300 mg Gastro-resistant
capsule, soft
Oral Use
Romania GEROT
PHARMAZEUTIKA
Ges.m.b.H.
Arnethgasse 3
A-1160, Wien
Austria
CONVULEX® 500
mg
Valproic Acid,
Sodium Valproate
500 mg Gastro-resistant
capsule, soft
Oral Use
Romania SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
DEPAKINE Valproic Acid,
Sodium Valproate
57.64 mg/ml Syrup Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 115/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Romania SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
DEPAKINE 200 mg Valproic Acid,
Sodium Valproate
200 mg Gastro-resistant
tablet
Oral Use
Romania SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
DEPAKINE CHRONO
300 mg
Valproic Acid,
Sodium Valproate
300 mg Prolonged-release
tablet
Oral Use
Romania SANOFI-AVENTIS
FRANCE
1-13, Boulevard
Romain Rolland
75014 Paris
France
DEPAKINE CHRONO
500 mg
Valproic Acid,
Sodium Valproate
500 mg Prolonged-release
tablet
Oral Use
Romania Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL 150 Valproic Acid,
Sodium Valproate
150 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 116/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Romania Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL 300 Valproic Acid,
Sodium Valproate
300 mg Gastro-resistant
tablet
Oral Use
Romania Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL 600 Valproic Acid,
Sodium Valproate
600 mg Gastro-resistant
tablet
Oral Use
Romania Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL LONG 150
mg
Valproic Acid,
Sodium Valproate
150 mg Prolonged-release
capsule
Oral Use
Romania Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL LONG 300
mg
Valproic Acid,
Sodium Valproate
300 mg Prolonged-release
capsule
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 117/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Romania Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL LONG 500
mg
Valproic Acid,
Sodium Valproate
500 mg Prolonged-release
tablet
Oral Use
Romania Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL LONG
1000 mg
Valproic Acid,
Sodium Valproate
1000 mg Prolonged-release
tablet
Oral Use
Romania Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
ORFIRIL SIROP Valproic Acid,
Sodium Valproate
300 mg / 5 ml Syrup Oral Use
Romania S.C. ARENA GROUP
S.A.
Str. Ştefan
Mihăileanu nr. 31,
Sector 2
Bucureşti
România
VALEPIL Valproic Acid,
Sodium Valproate
200 mg / 5 ml Syrup Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 118/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Slovak Republic Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor 300 mg
tablety s
predĺženým
uvoľňovaním
Valproic acid 300 mg Prolonged-release
tablet
oral use
Slovak Republic Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor 500 mg
tablety s
predĺženým
uvoľňovaním
Valproic acid 500 mg Prolonged-release
tablet
oral use
Slovak Republic G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex sodium valproate 50 mg Syrup oral use
Slovak Republic G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 300
mg/ml kvapky
sodium valproate 300mg/ml Oral drops, solution oral use
Slovak Republic G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 150 mg
kapsuly
Valproic acid 150 mg Capsule oral use
Slovak Republic G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 300 mg
kapsuly
Valproic acid 300 mg Capsule oral use
Slovak Republic G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex 500 mg
kapsuly
Valproic acid 500 mg Capsule oral use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 119/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Slovak Republic G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex CR 500
mg
sodium valproate 500 mg Prolonged-release
tablet
oral use
Slovak Republic Sanofi-Aventis
Slovakia s r.o.
Einsteinova 24
85101 Bratislava
Slovak Republic
Depakine Valproic acid 5.764 g / 100
ml
Syrup oral use
Slovak Republic Sanofi-Aventis
Slovakia s r.o.
Einsteinova 24
85101 Bratislava
Slovak Republic
Depakine Chrono
500 mg
Valproic Acid, Sodium
Valproate
500 mg Prolonged-release
tablet
oral use
Slovak Republic Sanofi-Aventis
Slovakia s r.o.
Einsteinova 24
85101 Bratislava
Slovak Republic
Depakine 400 mg/4
ml
Valproic acid 400 mg / 4 ml Powder and solvent
for solution for
injection
intravenous use
Slovak Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 150mg, Sodium Valproate 150mg Gastro-resistant
tablet
oral use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 120/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Slovak Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 300 Sodium Valproate 300 mg Gastro-resistant
tablet
oral use
Slovak Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril 600 Sodium Valproate 600mg Gastro-resistant
tablet
oral use
Slovak Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril
Injektionslösung
Sodium Valproate 100 mg/ml Solution for
injection
intravenous use
Slovak Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril long 1000
mg
Sodium Valproate 1000 mg Prolonged-release
tablet
oral use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 121/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Slovak Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril long 150 mg Sodium Valproate 150 mg Prolonged-release
capsule
oral use
Slovak Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril long 300 mg Sodium Valproate 300 mg Prolonged-release
capsule
oral use
Slovak Republic Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril long 500 mg Sodium Valproate 500 mg Prolonged-release
tablet
oral use
Slovak Republic Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Valpro-ratiopharm
Chrono 500 mg
Valproid Acid, Sodium
Valproate
500 mg Prolonged-release
tablet
oral use
Slovak Republic Sandoz
Pharmaceuticals d.d
Verovškova 57
1000 Ľubľana
Slovenia
Valproát chrono
Sandoz 300 mg
tablety s
predľženým
uvoľňovaním
Valproid Acid, Sodium
Valproate
300 mg Modified-release
tablet
oral use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 122/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Slovak Republic Sandoz
Pharmaceuticals d.d
Verovškova 57
1000 Ľubľana
Slovenia
Valproát chrono
Sandoz 500 mg
tablety s
predľženým
uvoľňovaním
Valproid Acid, Sodium
Valproate
500 mg Modified-release
tablet
oral use
Slovenia Sanofi-Aventis d.o.o.
Dunajska cesta 151
1000 Ljubljana
Slovenia
Depakine chrono
500 mg tablete s
podaljšanim
sproščanjem
Valproic acid 500 mg Prolonged-release
tablet
Oral Use
Slovenia Sanofi-Aventis d.o.o.
Dunajska cesta 151
1000 Ljubljana
Slovenia
Depakine chrono
300 mg tablete s
podaljšanim
sproščanjem
Valproic acid 300 mg Prolonged-release
tablet
Oral Use
Spain SANOFI AVENTIS,
S.A.
Josep Plá, 2
08019 Barcelona
Spain
Depakine 200 mg
comprimidos
gastrorresistentes
Sodium Valproate 200 mg Gastro-resistant
tablet
Oral Use
Spain SANOFI AVENTIS,
S.A.
Josep Plá, 2
08019 Barcelona
Spain
Depakine 500 mg
comprimidos
gastrorresistentes
Sodium Valproate 500 mg Gastro-resistant
tablet
Oral Use
Spain SANOFI AVENTIS,
S.A.
Josep Plá, 2
08019 Barcelona
Spain
Depakine 200
mg/ml solución oral
Sodium Valproate 200 mg/ml Oral solution Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 123/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Spain SANOFI AVENTIS,
S.A.
Josep Plá, 2
08019 Barcelona
Spain
Depakine 100
mg/ml polvo y
disolvente para
solución inyectable
Sodium Valproate 400 mg / 4 ml Powder and solvent
for solution for
injection
Intravenous Use
Spain GENFARMA
LABORATORIO, S.L.
Cólquide 6, portal
2º, 1ª planta.
Oficina D
28230 Las Rozas
(Madrid)
Spain
Acido Valproico
Genfarma 400 mg
polvo y disolvente
para solución
inyectable EFG
Sodium Valproate 400 mg / 4 ml Powder and solvent
for solution for
injection
Intravenous Use
Spain GES GENERICOS
ESPAÑOLES
LABORATORIO, S.A.
Cólquide 6, portal
2º, 1ª planta.
Oficina D
28230 Las Rozas
(Madrid)
Spain
Acido Valproico
GES 400 mg polvo
y disolvente para
solución inyectable
EFG
Sodium Valproate 400 mg / 4 ml Powder and solvent
for solution for
injection
Intravenous Use
Spain SANOFI AVENTIS,
S.A.
Josep Plá, 2
08019 Barcelona
Spain
Depakine Crono
300 mg
comprimidos
recubiertos
Valproic Acid,
Sodium Valproate
87 mg,
200 mg
Coated tablet Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 124/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Spain SANOFI AVENTIS,
S.A.
Josep Plá, 2
08019 Barcelona
Spain
Depakine Crono
500 mg
comprimidos
recubiertos
Valproic Acid,
Sodium Valproate
145 mg,
333 mg
Coated tablet Oral Use
Spain SANOFI AVENTIS,
S.A.
Josep Plá, 2
08019 Barcelona
Spain
Depamide 300 mg
comprimidos
gastrorresistentes
Valpromide 300 mg Gastro-resistant
tablet
Oral Use
Sweden Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor® sodium valproate 200 mg/ml Oral drops, solution Oral Use
Sweden Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor® sodium valproate 300 mg Tablet Oral Use
Sweden Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor® sodium valproate 100 mg Gastro-resistant
tablet
Oral Use
Sweden Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor® sodium valproate 300 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 125/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Sweden Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor® sodium valproate 500 mg Gastro-resistant
tablet
Oral Use
Sweden Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor® sodium valproate 60 mg/ml Oral solution Oral Use
Sweden Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor® Depot sodium valproate 500 mg Prolonged-release
tablet
Oral Use
Sweden Orion Corporation
Orionintie 1 A
FI-02200 Espoo
Finland
Absenor® Depot sodium valproate 300 mg Prolonged-release
tablet
Oral Use
Sweden Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril sodium valproate 150 mg Gastro-resistant
tablet
Oral Use
Sweden Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril sodium valproate 300 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 126/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Sweden Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril long sodium valproate 150 mg Prolonged-release
capsule, hard
Oral Use
Sweden Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril long sodium valproate 300 mg Prolonged-release
capsule, hard
Oral Use
Sweden Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril long sodium valproate 500 mg Prolonged-release
granules
Oral Use
Sweden Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Orfiril long sodium valproate 1000 mg Prolonged-release
granules
Oral Use
Sweden sanofi-aventis AB
Box 14142
167 14 Bromma
Sweden
Ergenyl sodium valproate 200 mg/ml Oral drops, solution Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 127/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Sweden sanofi-aventis AB
Box 14142
167 14 Bromma
Sweden
Ergenyl sodium valproate 100 mg Gastro-resistant
tablet
Oral Use
Sweden sanofi-aventis AB
Box 14142
167 14 Bromma
Sweden
Ergenyl sodium valproate 300 mg Gastro-resistant
tablet
Oral Use
Sweden sanofi-aventis AB
Box 14142
167 14 Bromma
Sweden
Ergenyl sodium valproate 500 mg Gastro-resistant
tablet
Oral Use
Sweden sanofi-aventis AB
Box 14142
167 14 Bromma
Sweden
Ergenyl sodium valproate 60 mg/ml Oral solution Oral Use
Sweden sanofi-aventis AB
Box 14142
167 14 Bromma
Sweden
Ergenyl sodium valproate 400 mg Powder and solvent
for solution for
injection
Oral Use
Sweden sanofi-aventis AB
Box 14142
167 14 Bromma
Sweden
Ergenyl Retard sodium valproate 100 mg Prolonged-release
tablet
Oral Use
Sweden sanofi-aventis AB
Box 14142
167 14 Bromma
Sweden
Ergenyl Retard sodium valproate 300 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 128/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
Sweden sanofi-aventis AB
Box 14142
167 14 Bromma
Sweden
Ergenyl Retard sodium valproate 500 mg Prolonged-release
tablet
Oral Use
Sweden sanofi-aventis AB
Box 14142
167 14 Bromma
Sweden
Ergenyl Retard sodium valproate 250 mg Prolonged-release
granules in sachet
Oral Use
Sweden sanofi-aventis AB
Box 14142
167 14 Bromma
Sweden
Ergenyl Retard sodium valproate 500 mg Prolonged-release
granules in sachet
Oral Use
Sweden sanofi-aventis AB
Box 14142
167 14 Bromma
Sweden
Ergenyl Retard sodium valproate 750 mg Prolonged-release
granules in sachet
Oral Use
Sweden sanofi-aventis AB
Box 14142
167 14 Bromma
Sweden
Ergenyl Retard sodium valproate 1000 mg Prolonged-release
granules in sachet
Oral Use
The Netherlands Sanofi-Aventis
Netherlands B.V.
Kampenringweg 45
D-E
2803 PE GOUDA
The Netherlands
Depakine Chrono
300, tabletten met
gereguleerde
afgifte 300 mg
Sodium valproate,
Valproic acid
200 mg,
87 mg
Modified-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 129/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
The Netherlands Sanofi-Aventis
Netherlands B.V.
Kampenringweg 45
D-E
2803 PE GOUDA
The Netherlands
Depakine Chrono
500, tabletten met
gereguleerde
afgifte 500 mg
Sodium valproate,
Valproic acid
333 mg,
145 mg
Modified-release
tablet
Oral Use
The Netherlands Sanofi-Aventis
Netherlands B.V.
Kampenringweg 45
D-E
2803 PE GOUDA
The Netherlands
Depakine
Chronosphere 100
mg, granulaat met
gereguleerde
afgifte
Sodium valproate,
Valproic acid
66.66 mg,
29.03 mg
Modified-release
granules
Oral Use
The Netherlands Sanofi-Aventis
Netherlands B.V.
Kampenringweg 45
D-E
2803 PE GOUDA
The Netherlands
Depakine
Chronosphere 1000
mg, granulaat met
gereguleerde
afgifte
Sodium valproate,
Valproic acid
666.6 mg,
290.27 mg
Modified-release
granules
Oral Use
The Netherlands Sanofi-Aventis
Netherlands B.V.
Kampenringweg 45
D-E
2803 PE GOUDA
The Netherlands
Depakine
Chronosphere 250
mg, granulaat met
gereguleerde
afgifte
Sodium valproate,
Valproic acid
166.76 mg,
72.61 mg
Modified-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 130/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
The Netherlands Sanofi-Aventis
Netherlands B.V.
Kampenringweg 45
D-E
2803 PE GOUDA
The Netherlands
Depakine
Chronosphere 500
mg, granulaat met
gereguleerde
afgifte
Sodium valproate,
Valproic acid
333.3 mg,
145.14 mg
Modified-release
granules
Oral Use
The Netherlands Sanofi-Aventis
Netherlands B.V.
Kampenringweg 45
D-E
2803 PE GOUDA
The Netherlands
Depakine
Chronosphere 750
mg, granulaat met
gereguleerde
afgifte
Sodium valproate,
Valproic acid
500.06 mg,
217.75 mg
Modified-release
granules
Oral Use
The Netherlands Sanofi-Aventis
Netherlands B.V.
Kampenringweg 45
D-E
2803 PE GOUDA
The Netherlands
Depakine Enteric,
maagsapresistente
tabletten 150 mg
sodium valproate 150 mg Gastro-resistant
tablet
Oral Use
The Netherlands Sanofi-Aventis
Netherlands B.V.
Kampenringweg 45
D-E
2803 PE GOUDA
The Netherlands
Depakine Enteric,
maagsapresistente
tabletten 300 mg
sodium valproate 300 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 131/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
The Netherlands Sanofi-Aventis
Netherlands B.V.
Kampenringweg 45
D-E
2803 PE GOUDA
The Netherlands
Depakine Enteric,
maagsapresistente
tabletten 500 mg
sodium valproate 500 mg Gastro-resistant
tablet
Oral Use
The Netherlands Sanofi-Aventis
Netherlands B.V.
Kampenringweg 45
D-E
2803 PE GOUDA
The Netherlands
Depakine i.v. 400,
poeder voor
injectievloeistof
400 mg
sodium valproate 400 mg Powder and solvent
for solution for
injection
Intravenous Use
The Netherlands Sanofi-Aventis
Netherlands B.V.
Kampenringweg 45
D-E
2803 PE GOUDA
The Netherlands
Depakine
suikervrije stroop,
drank 200 mg/5 ml
sodium valproate 40 mg/ml Oral solution Oral Use
The Netherlands Sanofi-Aventis
Netherlands B.V.
Kampenringweg 45
D-E
2803 PE GOUDA
The Netherlands
Depakine vloeistof
voor kinderen,
vloeistof voor oraal
gebruik 300 mg/ml
sodium valproate 300 mg/ml Oral liquid Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 132/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
The Netherlands Sanofi-Aventis
Netherlands B.V.
Kampenringweg 45
D-E
2803 PE GOUDA
The Netherlands
Natrii valproas,
maagsapresistente
tabletten 300 mg
sodium valproate 300 mg Gastro-resistant
tablet
Oral Use
The Netherlands Apotex Europe B.V.
Darwinweg 20
2333 CR LEIDEN
The Netherlands
Natriumvalproaat
Apotex 150 mg,
maagsapresistente
tabletten
sodium valproate 150 mg Gastro-resistant
tablet
Oral Use
The Netherlands Apotex Europe B.V.
Darwinweg 20
2333 CR LEIDEN
The Netherlands
Natriumvalproaat
Apotex 300 mg,
maagsapresistente
tabletten
sodium valproate 300 mg Gastro-resistant
tablet
Oral Use
The Netherlands Apotex Europe B.V.
Darwinweg 20
2333 CR LEIDEN
The Netherlands
Natriumvalproaat
Apotex 300 mg/5
ml, drank
sodium valproate 60 mg/ml Oral solution Oral Use
The Netherlands Apotex Europe B.V.
Darwinweg 20
2333 CR LEIDEN
The Netherlands
Natriumvalproaat
Apotex 600 mg,
maagsapresistente
tabletten
sodium valproate 600 mg Gastro-resistant
tablet
Oral Use
The Netherlands Centrafarm B.V.
Nieuwe Donk 3
4879 AC ETTEN
LEUR
The Netherlands
Natriumvalproaat
Chrono CF 300 mg,
tabletten met
verlengde afgifte
Sodium valproate,
Valproic acid
200 mg,
87 mg
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 133/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
The Netherlands Centrafarm B.V.
Nieuwe Donk 3
4879 AC ETTEN
LEUR
The Netherlands
Natriumvalproaat
Chrono CF 500 mg,
tabletten met
verlengde afgifte
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
The Netherlands Sandoz B.V.
Veluwezoom 22
1327 AH ALMERE
The Netherlands
Natriumvalproaat
Chrono Sandoz 300
mg, tabletten met
verlengde afgifte
Sodium valproate,
Valproic acid
200 mg,
87 mg
Prolonged-release
tablet
Oral Use
The Netherlands Sandoz B.V.
Veluwezoom 22
1327 AH ALMERE
The Netherlands
Natriumvalproaat
Chrono Sandoz 500
mg, tabletten met
verlengde afgifte
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
The Netherlands Teva Nederland B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands
Natriumvalproaat
chrono 300 mg
Teva, tabletten met
gereguleerde
afgifte
Sodium valproate,
Valproic acid
200 mg,
87 mg
Modified-release
tablet
Oral Use
The Netherlands Teva Nederland B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands
Natriumvalproaat
chrono 500 mg
Teva, tabletten met
gereguleerde
afgifte
Sodium valproate,
Valproic acid
333 mg,
145 mg
Modified-release
tablet
Oral Use
The Netherlands Sandoz B.V.
Veluwezoom 22
1327 AH ALMERE
The Netherlands
Natriumvalproaat
Sandoz Chrono
300, tabletten met
verlengde afgifte
300 mg
Sodium valproate,
Valproic acid
200 mg,
87 mg
Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 134/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
The Netherlands Sandoz B.V.
Veluwezoom 22
1327 AH ALMERE
The Netherlands
Natriumvalproaat
Sandoz Chrono
500, tabletten met
verlengde afgifte
500 mg
Sodium valproate,
Valproic acid
333 mg,
145 mg
Prolonged-release
tablet
Oral Use
The Netherlands Pharmachemie B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands
Orfiril CR 1000 mg,
granulaat met
gereguleerde
afgifte
sodium valproate 1000 mg Modified-release
granules
Oral Use
The Netherlands Pharmachemie B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands
Orfiril CR 150 mg,
capsules met
gereguleerde
afgifte
sodium valproate 150 mg Modified-release
capsule, hard
Oral Use
The Netherlands Pharmachemie B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands
Orfiril CR 300 mg,
capsules met
gereguleerde
afgifte
sodium valproate 300 mg Modified-release
capsule, hard
Oral Use
The Netherlands Pharmachemie B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands
Orfiril CR 500 mg,
granulaat met
gereguleerde
afgifte
sodium valproate 500 mg Modified-release
granules
Oral Use
The Netherlands Pharmachemie B.V.
Swensweg 5
2031 GA HAARLEM
The Netherlands
Orfiril 100 mg/ml,
oplossing voor
injectie
sodium valproate 100 mg/ml Solution for
injection
Intravenous Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 135/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
The Netherlands Apotex Europe B.V.
Darwinweg 20
2333 CR LEIDEN
The Netherlands
Propymal Enteric
150 mg,
maagsapresistente
capsules
Valproic acid 150 mg Gastro-resistant
capsule
Oral Use
The Netherlands Apotex Europe B.V.
Darwinweg 20
2333 CR LEIDEN
The Netherlands
Propymal Enteric
300 mg,
maagsapresistente
capsules
Valproic acid 300 mg Gastro-resistant
capsule
Oral Use
The Netherlands Apotex Europe B.V.
Darwinweg 20
2333 CR LEIDEN
The Netherlands
Propymal Enteric
450 mg,
maagsapresistente
capsules
Valproic acid 450 mg Gastro-resistant
capsule
Oral Use
The Netherlands Apotex Europe B.V.
Darwinweg 20
2333 CR LEIDEN
The Netherlands
Propymal Enteric
600 mg,
maagsapresistente
capsules
Valproic acid 600 mg Gastro-resistant
capsule
Oral Use
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Depakote 250mg
Tablets
Valproate Semisodium 269.1 mg Gastro-resistant
tablet
Oral Use
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Depakote 500mg
Tablets
Valproate Semisodium 538.2 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 136/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Epilim Liquid Sodium Valproate 200 mg / 5 ml Oral solution Oral Use
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Epilim Syrup
200mg/5ml
Sodium Valproate 200 mg / 5 ml Oral solution Oral Use
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Epilim 200 Gastro-
Resistant Tablets
Sodium Valproate 200 mg Gastro-resistant
tablet
Oral Use
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Epilim 500 Gastro-
Resistant Tablets
Sodium Valproate 500 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 137/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Epilim Chrono
200mg Controlled
Release Tablets
Valproic Acid,
Sodium Valproate
58 mg,
133.2 mg
Modified-release
tablet
Oral Use
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Epilim Chrono
300mg Controlled
Release Tablets
Valproic Acid,
Sodium Valproate
87 mg,
199.8 mg
Modified-release
tablet
Oral Use
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Epilim Chrono
500mg Controlled
Release Tablets
Valproic Acid,
Sodium Valproate
145 mg,
333 mg
Modified-release
tablet
Oral Use
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Epilim
Chronosphere MR
50mg Modified
Release Granules
Valproic Acid,
Sodium Valproate
14.51 mg,
33.33mg
Modified-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 138/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Epilim
Chronosphere MR
100mg Modified
Release Granules
Valproic Acid,
Sodium Valproate
29.03mg,
66.66mg
Modified-release
granules
Oral Use
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Epilim
Chronosphere MR
250mg Modified
Release Granules
Valproic Acid,
Sodium Valproate
72.61mg,
166.76mg
Modified-release
granules
Oral Use
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Epilim
Chronosphere MR
500mg Modified
Release Granules
Valproic Acid,
Sodium Valproate
145.14 mg,
333.3 mg
Modified-release
granules
Oral Use
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Epilim
Chronosphere MR
750mg Modified
Release Granules
Valproic Acid,
Sodium Valproate
217.75mg,
500.06 mg
Modified-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 139/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Epilim
Chronosphere MR
1000mg Modified
Release Granules
Valproic Acid,
Sodium Valproate
290.27 mg,
666.6 mg
Modified-release
granules
Oral Use
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Epilim 100mg
Crushable Tablet
Sodium Valproate 100 mg Tablet Oral Use
United Kingdom Aventis Pharma
Limited
One Onslow Street
Guildford, Surrey
GU1 4SY
UK
Epilim 400mg
Powder & solvent
for solution for
injection
Sodium Valproate 400 mg Powder for injection Intravenous Use
United Kingdom Teva UK Limited
Brampton Road,
Hampden Park
Eastbourne, East
Sussex
BN 22 9AG
United Kingdom
Sodium Valproate
200mg Gastro-
resistant tablets
Sodium Valproate 200 mg Coated tablet Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 140/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
United Kingdom Teva UK Limited
Brampton Road,
Hampden Park
Eastbourne, East
Sussex
BN 22 9AG
United Kingdom
Sodium Valproate
500mg Gastro-
resistant tablets
Sodium Valproate 500 mg Gastro-resistant
tablet
Oral Use
United Kingdom Norton Healthcare
Limited
Ridings Point,
Whistler Drive
Castleford
WF10 5HX
United Kingdom
Sodium Valproate
Oral solution BP
200mg/5ml
Sodium Valproate 200 mg / 5 ml Oral solution Oral Use
United Kingdom Generics UK Limited
Station Close,
Potter's Bar
Hertfordshire
EN6 1TL
United Kingdom
Sodium Valproate
Tablets 200mg
Sodium Valproate 200 mg Coated tablet Oral Use
United Kingdom Generics UK Limited
Station Close,
Potter's Bar
Hertfordshire
EN6 1TL
United Kingdom
Sodium Valproate
Tablets BP 500mg
EC
Sodium Valproate 500 mg Coated tablet Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 141/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
United Kingdom Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Episenta 150mg
Prolonged-release
capsules
Sodium Valproate 150 mg Prolonged-release
capsule
Oral Use
United Kingdom Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Episenta 300mg
Prolonged-release
capsules
Sodium Valproate 300 mg Prolonged-release
capsule
Oral Use
United Kingdom Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Episenta 500mg
Prolonged-release
Granules
Sodium Valproate 500 mg Prolonged-release
granules
Oral Use
United Kingdom Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Episenta 1000mg
Prolonged-release
Granules
Sodium Valproate 1000 mg Prolonged-release
granules
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 142/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
United Kingdom Desitin Arzneimittel
Gmbh
Weg beim Jaeger
214
DE-22335 Hamburg
Germany
Episenta solution
for injection
Sodium Valproate 100 mg/ml Solution for
injection
Intravenous Use
United Kingdom Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Valprotek CR 300
mg (prolonged
release) tablets
Sodium valproate,
Valproic acid
300 mg Prolonged-release
tablet
Oral Use
United Kingdom Ratiopharm GmbH
Graf-Arco-Strasse 3
89079 Ulm
Germany
Valprotek CR 500
mg (prolonged
release) tablets
Sodium valproate,
Valproic acid
500 mg Prolonged-release
tablet
Oral Use
United Kingdom Winthrop
Pharmaceuticals UK
Limited
One Onslow Street
Guildford, Surrey
GU1 4YS
United Kingdom
Sodium valproate
liquid 200mg/5ml
Sodium Valproate 200 mg / 5 ml Oral solution Oral Use
United Kingdom Winthrop
Pharmaceuticals UK
Limited
One Onslow Street
Guildford, Surrey
GU1 4YS
United Kingdom
Sodium valproate
200mg gastro-
resistant tablets
Sodium Valproate 200 mg Gastro-resistant
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 143/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
United Kingdom Winthrop
Pharmaceuticals UK
Limited
One Onslow Street
Guildford, Surrey
GU1 4YS
United Kingdom
Sodium valproate
500mg gastro-
resistant tablets
Sodium Valproate 500 mg Gastro-resistant
tablet
Oral Use
United Kingdom G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Capsules
300mg
Valproic acid 500 mg Gastro-resistant
capsule
Oral Use
United Kingdom G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Capsules
500mg
Valproic acid 300 mg Gastro-resistant
capsule
Oral Use
United Kingdom G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Convulex Capsules
150mg
Valproic acid 150 mg Gastro-resistant
capsule
Oral Use
United Kingdom G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Epival CR 300mg
prolonged-release
tablets
Sodium Valproate 300 mg Prolonged-release
tablet
Oral Use
United Kingdom G.L. Pharma GmbH
Schlossplatz 1
A-8502 Lannach
Austria
Epival CR 500mg
prolonged-release
tablets
Sodium Valproate 500 mg Prolonged-release
tablet
Oral Use
Annex I - List of the medicines affected by the referral
EMA/678403/2013 Page 144/144
Member State in
EEA
Marketing
authorisaton
holder
Product name INN Strength Pharmaceutical
form
Route of
administration
United Kingdom Wockhardt UK
Limited
Ash Road North
Wrexham Industrial
Estate
Wrexham, LL13 9UF
United Kingdom
Orlept (SF) Liquid
or Sodium
Valproate 40mg/ml
oral solution
Sodium Valproate 200 mg / 5 ml Oral solution Oral Use
United Kingdom Wockhardt UK
Limited
Ash Road North
Wrexham Industrial
Estate
Wrexham, LL13 9UF
United Kingdom
Orlept 200mg
gastro-resistant
tablets
Sodium Valproate 200 mg Gastro-resistant
tablet
Oral Use
United Kingdom Wockhardt UK
Limited
Ash Road North
Wrexham Industrial
Estate
Wrexham, LL13 9UF
United Kingdom
Orlept 500mg
gastro-resistant
tablets
Sodium Valproate 500 mg Gastro-resistant
tablet
Oral Use
United Kingdom Wockhardt UK
Limited
Ash Road North
Wrexham Industrial
Estate
Wrexham, LL13 9UF
United Kingdom
Sodium valproate
100mg/ml solution
for injection or
infusion
Sodium Valproate 100 mg Solution for
injection/infusion
Intravenous Use