Valproate - Art 31 - 1387 - Annex I for publication · DEPAKINE CHRONO 300 mg filmom obložene...

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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 /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


Schlossplatz 1

A-8502 Lannach

Austria

Convulex 150 mg -

Kapseln

Valproic acid 150 mg Gastro-resistant

capsule, soft

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex 300 mg -

Kapseln


capsule, soft

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex 500 mg -

Kapseln


capsule, soft

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex 300 mg -

Retardtabletten

sodium valproate 300 mg Prolonged-release

tablet

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex 500 mg -

Retardtabletten


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Schlossplatz 1

A-8502 Lannach

Austria

Convulex 300

mg/ml - Lösung

zum Einnehmen

sodium valproate 300 mg/ml Oral solution Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex 50 mg/ml

- Sirup für Kinder

Valproic acid 50 mg/ml

(sodium

valproate)

Syrup Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Natriumvalproat

G.L. 300 mg -

Retardtabletten


tablet

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Natriumvalproat

G.L. 500 mg -

Retardtabletten


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


SATURN Tower,

Vienna DC

Leonard-Bernstein-

Straße 10

1220 Wien

Austria

Depakine 300

mg/ml Tropfen


Belgium Takeda Belgium

Gentsesteenweg 615

1080 Brussels

Belgium

Convulex 300 mg Valproic acid 300 mg Capsule, hard Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


Airport Plaza,

Montreal Building

Leonardo Da

Vincilaan 19

1831 Diegem

Belgium

Depakine 300 mg/5

ml

Valproate sodium 60 mg/ml Syrup Oral Use


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


Airport Plaza,

Montreal Building

Leonardo Da

Vincilaan 19

1831 Diegem

Belgium

Depakine Enteric

150 mg

Valproate sodium 150 mg Tablet Oral Use


Airport Plaza,

Montreal Building

Leonardo Da

Vincilaan 19

1831 Diegem

Belgium

Depakine Enteric

300 mg



Airport Plaza,

Montreal Building

Leonardo Da

Vincilaan 19

1831 Diegem

Belgium

Depakine Enteric

500 mg



EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Schlossplatz 1

A-8502 Lannach

Austria

Convulex Chrono Sodium Valproate 500 mg Prolonged-release

tablet

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex Valproic acid 500 mg Gastro-resistant

capsule, soft

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria


capsule, soft

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex Sodium Valproate 50 mg/ml Syrup Oral Use


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Bulgaria EOOD

103, Alexander

Stamboliiski Blvd

1303 Sofia

Bulgaria

Depakine Sodium Valproate 57.64 mg/ml Syrup Oral Use


Bulgaria EOOD

103, Alexander

Stamboliiski Blvd

1303 Sofia

Bulgaria

Depakine Sodium Valproate 500 mg Gastro-resistant

tablet

Oral Use


Bulgaria EOOD

103, Alexander

Stamboliiski Blvd

1303 Sofia

Bulgaria

Depakine Chrono Sodium Valproate 300 mg Prolonged-release

tablet

Oral Use


Bulgaria EOOD

103, Alexander

Stamboliiski Blvd

1303 Sofia

Bulgaria

Depakine Chrono Sodium Valproate 500 mg Prolonged-release

tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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 Ltd

Charalambou

Mouskou 14 Street

2015 Strovolos

Nicosia

Cyprus

Depakine

Chronosphere

Valproate sodium,

Valproic acid

500 mg Modified-release

granules

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Cyprus Ltd

Charalambou

Mouskou 14 Street

2015 Strovolos

Nicosia

Cyprus

Depakine

Chronosphere

Valproate sodium,

Valproic acid


granules

Oral Use


Cyprus Ltd

Charalambou

Mouskou 14 Street

2015 Strovolos

Nicosia

Cyprus

Depakine

Chronosphere

Valproate sodium,

Valproic acid


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


Schlossplatz 1

A-8502 Lannach

Austria



Schlossplatz 1

A-8502 Lannach

Austria

Convulex 150 Valproic acid 150 mg Capsule, soft Oral Use


Schlossplatz 1

A-8502 Lannach

Austria



Schlossplatz 1

A-8502 Lannach

Austria



Schlossplatz 1

A-8502 Lannach

Austria

Convulex CR 500

mg

Sodium Valproate 500 mg Prolonged-release

tablet

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex CR 300

mg


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


capsule, hard

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril Long 1000

mg


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril 300 Sodium Valproate 300 mg Gastro-resistant

tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril I.V. Sodium Valproate 300 mg Solution for

injection

Intravenous Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

Oral Use


Evropská 846/176a

160 00 Prague 6

Czech Republic

Depakine Sodium Valproate 5.764 g / 100

ml

Syrup Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril Valproic acid 600 mg Gastro-resistant

tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril Valproic acid 60 mg/ml Oral solution Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril Valproic acid 100 mg/ml Solution for

injection

Intravenous Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril Long Valproic acid 150 mg Prolonged-release

capsule

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


capsule

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


granules

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


granules

Oral Use


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


Orionintie 1 A

FI-02200 Espoo

Finland

Delepsine Valproic acid 100 mg Gastro-resistant

tablet

Oral Use


Orionintie 1 A

FI-02200 Espoo

Finland


tablet

Oral Use


Orionintie 1 A

FI-02200 Espoo

Finland


tablet

Oral Use


Orionintie 1 A

FI-02200 Espoo

Finland

Delepsine Valproic acid 60 mg/ml Oral solution Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Orionintie 1 A

FI-02200 Espoo

Finland

Delepsine Valproic acid 200 mg/ml Oral drops, solution Oral Use


Orionintie 1 A

FI-02200 Espoo

Finland

Delepsine Valproic acid 300 mg Suppository Rectal use


Orionintie 1 A

FI-02200 Espoo

Finland

Delepsine Retard Valproic acid 300 mg Prolonged-release

tablet

Oral Use


Orionintie 1 A

FI-02200 Espoo

Finland

Delepsine Retard Valproic acid 500 mg Prolonged-release

tablet

Oral Use


Orionintie 1 A

FI-02200 Espoo

Finland

Deprakine Valproic acid 300 mg Gastro-resistant

tablet

Oral Use


Orionintie 1 A

FI-02200 Espoo

Finland

Deprakine Valproic acid 500 mg Gastro-resistant

tablet

Oral Use


Orionintie 1 A

FI-02200 Espoo

Finland

Deprakine Retard Valproic acid 300 mg Prolonged-release

tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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 OÜ

Pärnu mnt 139E/2

11317 Tallinn

Estonia

DEPAKINE CHRONO

300 MG


tablet

Oral Use


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


Schlossplatz 1

A-8502 Lannach

Austria

CONVULEX 300

MG/ML

Valproic acid 300 mg/ml Oral drops, solution Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Schlossplatz 1

A-8502 Lannach

Austria

CONVULEX Valproic acid 50 mg/ml Syrup Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

CONVULEX 150 MG Valproic acid 150 mg Gastro-resistant

capsule, soft

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria


capsule, soft

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria


capsule, soft

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

CONVULEX RETARD

300MG


tablet

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

CONVULEX RETARD

500MG


tablet

Oral Use

Estonia Orion Corporation

Orionintie 1 A

FI-02200 Espoo

Finland

ABSENOR Valproic acid 300 mg Prolonged-release

tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


tablet

Oral Use

Estonia Sandoz d.d.

Verovškova 57

SI-1000 Ljubljana

Slovenia

VALPROATE

SODIUM SANDOZ

500MG


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


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

ORFIRIL Valproic acid 100 mg/ml Solution for

injection

Intravenous Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

ORFIRIL 300 Valproic acid 300 mg Gastro-resistant

tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

ORFIRIL LONG 150

MG


capsule

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

ORFIRIL LONG 300

MG


capsule

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

ORFIRIL LONG 500

MG


capsule

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

ORFIRIL LONG

1000 MG


capsule

Oral Use

Finland Orion Pharma

Orionintie 1

PL 65

02101 Espoo

Finland

ABSENOR Sodium Valproate 100 mg Gastro-resistant

tablet

Oral Use


Orionintie 1

PL 65

02101 Espoo

Finland


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Orionintie 1

PL 65

02101 Espoo

Finland


tablet

Oral Use


Orionintie 1

PL 65

02101 Espoo

Finland

ABSENOR Sodium Valproate 300 mg Prolonged-release

tablet

Oral Use


Orionintie 1

PL 65

02101 Espoo

Finland

ABSENOR Sodium Valproate 500 mg Prolonged-release

tablet

Oral Use


Orionintie 1

PL 65

02101 Espoo

Finland

ABSENOR Sodium Valproate 60 mg/ml Oral solution Oral Use


Orionintie 1

PL 65

02101 Espoo

Finland

ABSENOR Sodium Valproate 200 mg/ml Oral drops, solution Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


Huopalahdentie 24

PL 22

00351 Helsinki

Finland


tablet

Oral Use


Huopalahdentie 24

PL 22

00351 Helsinki

Finland


tablet

Oral Use


Huopalahdentie 24

PL 22

00351 Helsinki

Finland

DEPRAKINE Sodium valproate,

Valproic acid

300 mg Prolonged-release

tablet

Oral Use


Huopalahdentie 24

PL 22

00351 Helsinki

Finland

DEPRAKINE Sodium valproate,

Valproic acid


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Huopalahdentie 24

PL 22

00351 Helsinki

Finland

DEPRAKINE Sodium Valproate 60 mg/ml Oral solution Oral Use


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


capsule, hard

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

NATRIUMVALPROA

ATTI LONG

DESITIN


capsule, hard

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

NATRIUMVALPROA

ATTI LONG

DESITIN


granules

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

NATRIUMVALPROA

ATTI LONG

DESITIN


granules

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

ORFIRIL Sodium Valproate 100 mg/ml Solution for

injection

Intravenous Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

ORFIRIL LONG Sodium Valproate 150 mg Prolonged-release

capsule, hard

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


capsule, hard

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


granules

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


granules

Oral Use

Finland Sandoz A/S

C. F. Tietgens

Boulevard 40

5220 ODENSE SØ

Denmark

VALPROAT SANDOZ Sodium valproate,

Valproic acid


tablet

Oral Use

Finland Sandoz A/S

C. F. Tietgens

Boulevard 40

5220 ODENSE SØ

Denmark

VALPROAT SANDOZ Sodium valproate,

Valproic acid


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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

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

1-13, Boulevard

Romain Rolland

75014 Paris

France

DEPAKINE 500 mg,

comprimé gastro-

résistant


tablet

Oral Use


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

DEPAKINE 57,64

mg/ml, sirop

Sodium Valproate 57.64 mg Syrup Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

DEPAKINE CHRONO

500 mg, comprimé

pelliculé sécable à

libération

prolongée

Valproic Acid,

Sodium Valproate


tablet

Oral Use


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

1-13, Boulevard

Romain Rolland

75014 Paris

France

DEPAKOTE 500 mg,

comprimé gastro-

résistant

Valproate Semisodium 500 mg Gastro-resistant

tablet

Oral Use


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

DEPAMIDE 300 mg,

comprimé pelliculé

gastro-résistant

Valpromide 300 mg Gastro-resistant

tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


granules

Oral Use


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


granules

Oral Use


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

MICROPAKINE L.P.


libération

prolongée en

sachet-dose

Valproic Acid,

Sodium Valproate


granules

Oral Use


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

MICROPAKINE L.P.


libération

prolongée en

sachet-dose

Valproic Acid,

Sodium Valproate


granules

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

MICROPAKINE L.P.


libération

prolongée en

sachet-dose

Valproic Acid,

Sodium Valproate


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,


sécable à libération

prolongée

Valproic Acid,

Sodium Valproate


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


libération

prolongée


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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,



prolongée


tablet

Oral Use

France Biogaran

15, boulevard

Charles de Gaulle

92700 Colombes

France

VALPROATE DE

SODIUM

BIOGARAN L.P. 500

mg, comprimé


libération

prolongée


tablet

Oral Use


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

VALPROATE DE

SODIUM DAKOTA

PHARM 200 mg,

comprimé gastro-

résistant


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

VALPROATE DE

SODIUM DAKOTA

PHARM 500 mg,

comprimé gastro-

résistant


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


libération

prolongée


tablet

Oral Use

France SANDOZ

49, avenue Georges

Pompidou

92300 Levallois-

Perret

France

VALPROATE DE

SODIUM GNR L.P.

500 mg, comprimé


libération

prolongée


tablet

Oral Use

France MYLAN SAS

117, allée des Parcs

69800 Saint-Priest

France

VALPROATE DE

SODIUM MYLAN

L.P. 500 mg,



prolongée


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration

France Ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

VALPROATE DE

SODIUM

RATIOPHARM L.P.

500 mg, comprimé


libération

prolongée


tablet

Oral Use

France RANBAXY

PHARMACIE

GENERIQUES

11-15 Quai Dion

Bouton

92800 Puteaux

France

VALPROATE DE

SODIUM RPG L.P.

500 mg, comprimé


libération

prolongée


tablet

Oral Use

France SANDOZ

49, avenue Georges

Pompidou

92300 Levallois-

Perret

France

VALPROATE DE

SODIUM SANDOZ

LP 500 mg,



prolongée

Valproic Acid,

Sodium Valproate


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


libération

prolongée


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

VALPROATE DE

SODIUM ZENTIVA

200 mg, comprimé

gastro-résistant


tablet

Oral Use


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

VALPROATE DE

SODIUM ZENTIVA

200 mg/ml,

solution buvable



FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

VALPROATE DE

SODIUM ZENTIVA

500 mg, comprimé

gastro-résistant


tablet

Oral Use


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

VALPROATE DE

SODIUM ZENTIVA

L.P. 500 mg,



prolongée


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

VALPROATE DE

SODIUM-ACIDE

VALPROIQUE

DELALANDE L.P.


libération

prolongée en

sachet-dose

Valproic Acid,

Sodium Valproate


granules

Oral Use


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


granules

Oral Use


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

VALPROATE DE

SODIUM-ACIDE

VALPROIQUE

DELALANDE L.P.


libération

prolongée en

sachet-dose

Valproic Acid,

Sodium Valproate


granules

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


granules

Oral Use


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

VALPROATE DE

SODIUM-ACIDE

VALPROIQUE

DELALANDE L.P.


libération

prolongée en

sachet-dose

Valproic Acid,

Sodium Valproate


granules

Oral Use


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

VALPROATE DE

SODIUM-ACIDE

VALPROIQUE

DELALANDE L.P.


libération

prolongée en

sachet-dose

Valproic Acid,

Sodium Valproate


granules

Oral Use

Germany 1 A Pharma GmbH

Keltenring 1 + 3

82041 Oberhaching

Germany

Valproat - 1 A

Pharma 150 mg

magensaftresistent

e Filmtabletten


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Keltenring 1 + 3

82041 Oberhaching

Germany

Valproat - 1 A

Pharma 300 mg

magensaftresistent

e Filmtabletten


tablet

Oral Use


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


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


Keltenring 1 + 3

82041 Oberhaching

Germany

Valproat - 1 A

Pharma 600 mg

magensaftresistent

e Filmtabletten


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


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


Wallenroder Str. 8-

10

13435 Berlin

Germany

Valproat Aristo 300

mg

magensaftresistent

e Filmtabletten


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Wallenroder Str. 8-

10

13435 Berlin

Germany

Valproat Aristo 600

mg

magensaftresistent

e Filmtabletten


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


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


GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Valproat-CT 150mg

Filmtabletten


tablet

Oral Use


GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Valproat-CT 300

mg Filmtabletten


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


GmbH

Graf-Arco-Str. 3

89079 Ulm

Germany

Valproat-CT 600

mg Filmtabletten


tablet

Oral Use

Germany Desitin Arzneimittel

Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Natriumvalproat

Desitin retard 1000

mg


tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Natriumvalproat

Desitin retard 150

mg


tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Natriumvalproat

Desitin retard 300

mg


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Natriumvalproat

Desitin retard 500

mg


tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril 100mg/ml

Injektionslösung

Sodium Valproate 100 mg Solution for

injection

Intravenous Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril 100mg/ml

Injektionslösung


injection

Intravenous Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril 200 mg Sodium Valproate 200 mg Gastro-resistant

tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril 500 mg Sodium Valproate 500 mg Gastro-resistant

tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril long 1000

mg


tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orifiril long 150 mg Sodium Valproate 150 mg Prolonged-release

capsule

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


capsule

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


capsule

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril Saft Sodium Valproate 60 mg Oral solution Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril Saft Sodium Valproate 60 mg Oral solution Oral Use


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


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


Co.KG

Otto-von-Guericke-

Str. 1

53757 Sankt

Augustin

Germany


tablet

Oral Use


Co.KG

Otto-von-Guericke-

Str. 1

53757 Sankt

Augustin

Germany


tablet

Oral Use

Germany Dr. Lach Pharma

Consulting

Bahnhofstr. 6

79359 Riegel

Germany

Valproat-RPh

150mg


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Consulting

Bahnhofstr. 6

79359 Riegel

Germany

Valproat-RPh

300mg


tablet

Oral Use


Consulting

Bahnhofstr. 6

79359 Riegel

Germany

Valproat-RPh

600mg


tablet

Oral Use


Consulting

Bahnhofstr. 6

79359 Riegel

Germany

Valproat-RPh

Lösung


Germany G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Convulex 300 mg

Retardtabletten


tablet

Oral Use

Germany G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Convulex 500 mg

Retardtabletten


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration

Germany Heumann Pharma

GmbH & Co.

Generica KG

Südwestpark 50

90449 Nürnberg

Germany

Valproat Heumann

150 mg

magensaftresistent

e Tabletten


tablet

Oral Use


GmbH & Co.

Generica KG

Südwestpark 50

90449 Nürnberg

Germany

Valproat Heumann

300 mg

magensaftresistent

e Tabletten


tablet

Oral Use


GmbH & Co.

Generica KG

Südwestpark 50

90449 Nürnberg

Germany

Valproat Heumann

600 mg

magensaftresistent

e Tabletten


tablet

Oral Use


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


tablet

Oral Use

Germany Hexal

Aktiengesellschaft

Industriestr. 25

83607 Hozkirchen

Germany

Valproat HEXAL

300mg

Filmtabletten


tablet

Oral Use

Germany Hexal

Aktiengesellschaft

Industriestr. 25

83607 Hozkirchen

Germany

Valproat HEXAL

300mg/ml Lösung


Germany Hexal

Aktiengesellschaft

Industriestr. 25

83607 Hozkirchen

Germany

Valproat HEXAL

600mg

Filmtabletten


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


industrielle

Pharmazie

Forschungs- und


haft mbH

Benzstr. 2a

63741

Aschaffenburg

Germany

Valberg PR 500 mg Sodium valproate,

Valproic acid

333 mg,

145 mg

Prolonged-release

tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


industrielle

Pharmazie

Forschungs- und


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


industrielle

Pharmazie

Forschungs- und


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


Ericusspitze 2

20457 Hamburg

Germany

Convulex 300 Sodium Valproate 300 mg Gastro-resistant

tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Ericusspitze 2

20457 Hamburg

Germany

Convulex 500 Sodium Valproate 500 mg Gastro-resistant

tablet

Oral Use


Ericusspitze 2

20457 Hamburg

Germany

Convulex

Tropflösung


Germany Mylan dura GmbH

Wittichstr. 6

64295 Darmstadt

Germany

valprodura 150mg Sodium Valproate 150 mg Gastro-resistant

tablet

Oral Use


Wittichstr. 6

64295 Darmstadt

Germany

valprodura 300 mg Sodium Valproate 300 mg Gastro-resistant

tablet

Oral Use


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



EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration

Germany Neuraxpharm

Arzneimittel GmbH

Elisabeth-Selbert-

Str. 23

40764 Langelfeld

Germany

Valproat-

neuraxpharm

150 mg


tablet

Oral Use

Germany Neuraxpharm

Arzneimittel GmbH

Elisabeth-Selbert-

Str. 23

40764 Langelfeld

Germany

Valproat-

neuraxpharm

300 mg


tablet

Oral Use

Germany Neuraxpharm

Arzneimittel GmbH

Elisabeth-Selbert-

Str. 23

40764 Langelfeld

Germany

Valproat-

neuraxpharm

60 mg/ml

Lösung zum

Einnehmen


Germany Neuraxpharm

Arzneimittel GmbH

Elisabeth-Selbert-

Str. 23

40764 Langelfeld

Germany

Valproat-

neuraxpharm

600 mg


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration

Germany Orion Corporation

Orionintie 1 A

FI-02200 Espoo

Finland

Valproat Orion 500

mg Retardtabletten


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


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


Graf-Arco-Strasse 3

89079 Ulm

Germany

Valproinsäure-

ratiopharm 150

Filmtabletten


tablet

Oral Use


Graf-Arco-Strasse 3

89079 Ulm

Germany

Valproinsäure-

ratiopharm 300

Filmtabletten


tablet

Oral Use


Graf-Arco-Strasse 3

89079 Ulm

Germany

Valproinsäure-

ratiopharm 600

Filmtabletten


tablet

Oral Use


Graf-Arco-Strasse 3

89079 Ulm

Germany

Valproinsäure-

ratiopharm Lösung



EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


Deutschland GmbH

Industriepark

Höchst, Gebäude

K703

65926 Frankfurt am

Main

Germany


tablet

Oral Use


Deutschland GmbH

Industriepark

Höchst, Gebäude

K703

65926 Frankfurt am

Main

Germany


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


Deutschland GmbH

Industriepark

Höchst, Gebäude

K703

65926 Frankfurt am

Main

Germany

Ergenyl intravenös Sodium Valproate 400 mg Solution for

injection

Intravenous Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Deutschland GmbH

Industriepark

Höchst, Gebäude

K703

65926 Frankfurt am

Main

Germany

Ergenyl Lösung Sodium Valproate 300 mg Oral solution Oral Use


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


Heinz-Lohmann-Str.

5

27472 Cuxhaven

Germany


tablet

Oral Use


Heinz-Lohmann-Str.

5

27472 Cuxhaven

Germany


tablet

Oral Use


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


Heinz-Lohmann-Str.

5

27472 Cuxhaven

Germany

Valpro TAD chrono

500mg

Sodium valproate,

Valproic acid

333 mg,

145 mg

Prolonged-release

tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


348 Syngrou

Avenue, Building A'

17674 Kallithea

Greece

DEPAKINE CHRONO

(SPHERE)

Sodium valproate,

Valproic acid

100 mg/sachet Coated granules in

sachet

Oral Use


348 Syngrou

Avenue, Building A'

17674 Kallithea

Greece

DEPAKINE CHRONO

(SPHERE)

Sodium valproate,

Valproic acid


sachet

Oral Use


348 Syngrou

Avenue, Building A'

17674 Kallithea

Greece

DEPAKINE CHRONO

(SPHERE)

Sodium valproate,

Valproic acid


sachet

Oral Use


348 Syngrou

Avenue, Building A'

17674 Kallithea

Greece

DEPAKINE CHRONO

(SPHERE)

Sodium valproate,

Valproic acid


sachet

Oral Use


348 Syngrou

Avenue, Building A'

17674 Kallithea

Greece

DEPAKINE CHRONO

(SPHERE)

Sodium valproate,

Valproic acid

1000

mg/sachet

Coated granules in

sachet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


348 Syngrou

Avenue, Building A'

17674 Kallithea

Greece

DEPAKINE Sodium Valproate 500 mg/sachet Gastro-resistant

tablet

Oral Use


348 Syngrou

Avenue, Building A'

17674 Kallithea

Greece

DEPAKINE Sodium Valproate 200 mg/ml Oral solution Oral Use


348 Syngrou

Avenue, Building A'

17674 Kallithea

Greece

DEPAKINE Sodium Valproate 200 mg/tab Gastro-resistant

tablet

Oral Use


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


Schlossplatz 1

A-8502 Lannach

Austria

CONVULEX 150 mg

gyomornedv-

ellenálló lágy

kapszula


capsule, soft

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

CONVULEX 300 mg

gyomornedv-

ellenálló lágy

kapszula


capsule, soft

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

CONVULEX 300 mg

retard filmtabletta

Valproic acid 300 mg prolonged release

film-coated tablet

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

CONVULEX 50

mg/ml szirup

gyermekeknek

Valproic acid 50 mg/ml Syrup Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

CONVULEX 500 mg

gyomornedv-

ellenálló lágy

kapszula


capsule, soft

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

CONVULEX 500 mg

retard filmtabletta

Valproic acid 500 mg prolonged release

film-coated tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


Tó u. 5.

H-1045 Budapest

Hungary

DEPAKINE 50

mg/ml szirup

Valproic acid 50 mg/ml Syrup Oral Use


Tó u. 5.

H-1045 Budapest

Hungary

DEPAKINE CHRONO

300 mg filmtabletta

Valproic Acid,

Sodium Valproate

300 mg Film-coated tablet Oral Use


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


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril Retard Sodium Valproate 300 mg Prolonged-release

tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril Sodium Valproate 60 mg/ml Oral solution Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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 Ltd. T/A

SANOFI

Citywest Business

Campus

Dublin 24

Ireland

Epilim Enteric 200

mg gastro-resistant

coated tablets


tablet

Oral Use


Ireland Ltd. T/A

SANOFI

Citywest Business

Campus

Dublin 24

Ireland

Epilim Enteric

500mg Gastro-

resistant Coated

Tablets


tablet

Oral Use


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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 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 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 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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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 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 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 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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Ireland Ltd. T/A

SANOFI

Citywest Business

Campus

Dublin 24

Ireland

Epilim Liquid

200mg/5ml Oral

Solution.



Ireland Ltd. T/A

SANOFI

Citywest Business

Campus

Dublin 24

Ireland

Epilim Syrup

200mg/5ml Oral

Solution.


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


France SA

1-13 Boulevard

Romain Rolland

75014 PARIS

France

Depakin sodium valproate 200 mg Gastro-resistant

tablet

Oral Use


France SA

1-13 Boulevard

Romain Rolland

75014 PARIS

France

Depakin sodium valproate 500 mg Gastro-resistant

tablet

Oral Use


France SA

1-13 Boulevard

Romain Rolland

75014 PARIS

France

Depakin sodium valproate 200 mg/ml Oral solution Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


France SA

1-13 Boulevard

Romain Rolland

75014 PARIS

France


Sodium Valproate

66,66 mg

sodium

valproate +

29,03 mg

valproic acid

equivalent to

100 mg sodium

valproate

Modified-release

granules

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


France SA

1-13 Boulevard

Romain Rolland

75014 PARIS

France


Sodium Valproate

166,76 mg

sodium

valproate +

72,61 mg

valproic acid

(equivalent to

250 mg sodium

valproate)

Modified-release

granules

Oral Use


France SA

1-13 Boulevard

Romain Rolland

75014 PARIS

France


Sodium Valproate

333,30 mg

sodium

valproate +

145,14 mg

valproic acid

(equivalent to

500 mg sodium

valproate)

Modified-release

granules

Oral Use


France SA

1-13 Boulevard

Romain Rolland

75014 PARIS

France


Sodium Valproate

500.06 mg

sodium

valproate +

217.75 mg

valproic acid

(equivalent to

750 mg sodium

valproate)

Modified-release

granules

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


France SA

1-13 Boulevard

Romain Rolland

75014 PARIS

France


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


Viale Bodio 37/B

20158 Milano

Italy

Sodio Valproato

Zentiva


tablet

Oral Use


Viale Bodio 37/B

20158 Milano

Italy

Sodio Valproato

Zentiva



EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Farmaceutiche

Riunite SpA

Viale Shakespeare,

47

00144 Roma

Italy

Depamag magnesium valproate 500 mg Gastro-resistant

tablet

Oral Use


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


tablet

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex retard

500 mg prolonged

release tablets


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


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


SIA

Kr.Valdemara 33-8

Riga LV1010

Latvia

Depakine Chrono

500 mg slow-

release film-coated

tablets

Valproic Acid,

Sodium Valproate


tablet

Oral Use


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


Schlossplatz 1

A-8502 Lannach

Austria

Convulex 50 mg/ml

syrup

sodium valproate 50 mg/ml Syrup Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex 300

mg/ml oral solution



Schlossplatz 1

A-8502 Lannach

Austria

Convulex 500 mg

gastro-resistant

capsules, soft


capsule, soft

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex 150 mg

gastro-resistant

capsules, soft


capsule, soft

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Schlossplatz 1

A-8502 Lannach

Austria

Convulex 300 mg

gastro-resistant

capsules, soft


capsule, soft

Oral Use


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


tablet

Oral Use

Latvia Orion Corporation

Orionintie 1 A

FI-02200 Espoo

Finland

Absenor 500 mg

prolonged release

tablets


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


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


Schlossplatz 1

A-8502 Lannach

Austria


capsule, soft

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria


capsule, soft

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria


capsule, soft

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria



Schlossplatz 1

A-8502 Lannach

Austria

Convulex Sodium Valproate 300 mg/ml Oral solution Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex retard Sodium Valproate 300 mg Prolonged-release

tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


AVENTIS LIETUVA“


6/2

LT-09310 Vilnius

Lithuania

DEPAKINE CHRONO Sodium Valproate 300 mg Modified-release

tablet

Oral Use


AVENTIS LIETUVA“


6/2

LT-09310 Vilnius

Lithuania

DEPAKINE CHRONO Sodium Valproate 500 mg Modified-release

tablet

Oral Use


AVENTIS LIETUVA“


6/2

LT-09310 Vilnius

Lithuania

DEPAKINE

Chronosphere

Sodium Valproate 250 mg Modified-release

granules

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


AVENTIS LIETUVA“


6/2

LT-09310 Vilnius

Lithuania

DEPAKINE

Chronosphere


granules

Oral Use


AVENTIS LIETUVA“


6/2

LT-09310 Vilnius

Lithuania

DEPAKINE

Chronosphere


granules

Oral Use


AVENTIS LIETUVA“


6/2

LT-09310 Vilnius

Lithuania

DEPAKINE

Chronosphere


granules

Oral Use

Lithuania Sandoz d.d.

Verovškova 57

SI-1000 Ljubljana

Slovenia

Valproate sodium

Sandoz


tablet

Oral Use

Luxembourg Takeda Belgium

Chaussée de Gand

615

1080 Bruxelles

Belgium

Convulex gelule

gastro résistante


capsule

oral use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration

Luxembourg Takeda Belgium

Chaussée de Gand

615

1080 Bruxelles

Belgium

Convulex gelule

gastro résistante


capsule

oral use

Luxembourg Mylan BVBA/SPRL

Terhulpsesteenweg 6

box A

1560 Hoeilaart

Belgium

Convulex comprimé

gastro résistant


tablet

oral use

Luxembourg Mylan BVBA/SPRL

Terhulpsesteenweg 6

box A

1560 Hoeilaart

Belgium

Convulex comprimé

gastro résistant


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Airport Plaza,

Montreal Building

Leonardo Da

Vincilaan 19

1831 Diegem

Belgium

Depakine sirop sodium valproate 300 mg / 5 ml Syrup oral use


Airport Plaza,

Montreal Building

Leonardo Da

Vincilaan 19

1831 Diegem

Belgium

Depakine enteric sodium valproate 150 mg Gastro-resistant

tablet

oral use


Airport Plaza,

Montreal Building

Leonardo Da

Vincilaan 19

1831 Diegem

Belgium


tablet

oral use


Airport Plaza,

Montreal Building

Leonardo Da

Vincilaan 19

1831 Diegem

Belgium


tablet

oral use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Ltd.


Birkirkara BKR 1114

Malta

Epilim Chrono 500

controlled release

tab


tablet

Oral Use


Ltd.


Birkirkara BKR 1114

Malta

Epilim Chrono 300

controlled release

tab


tablet

Oral Use


Ltd.


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


GmbH

Postfach 630164

D-22311 HAMBURG

Deutschland

Orifril long Sodium valproate 1000 mg Prolonged-release

granules

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


GmbH

Postfach 630164

D-22311 HAMBURG

Deutschland


granules

Oral Use


GmbH

Postfach 630164

D-22311 HAMBURG

Deutschland


capsule

Oral Use


GmbH

Postfach 630164

D-22311 HAMBURG

Deutschland


capsule

Oral Use


GmbH

Postfach 630164

D-22311 HAMBURG

Deutschland

Orifril Sodium valproate 100 mg/ml Solution for

injection

Oral Use


GmbH

Postfach 630164

D-22311 HAMBURG

Deutschland

Orifril Sodium valproate 60 mg/ml Oral solution Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


GmbH

Postfach 630164

D-22311 HAMBURG

Deutschland

Orifril Sodium valproate 300 mg Gastro-resistant

tablet

Oral Use


GmbH

Postfach 630164

D-22311 HAMBURG

Deutschland


tablet

Oral Use


GmbH

Postfach 630164

D-22311 HAMBURG

Deutschland


tablet

Oral Use

Poland Orion Corporation

Orionintie 1 A

FI-02200 Espoo

Finland


tablet

Oral Use

Poland Orion Corporation

Orionintie 1 A

FI-02200 Espoo

Finland


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Schlossplatz 1

A-8502 Lannach

Austria

Convulex Valproic acid 500 mg Capsule, soft Oral Use


Schlossplatz 1

A-8502 Lannach

Austria



Schlossplatz 1

A-8502 Lannach

Austria



Schlossplatz 1

A-8502 Lannach

Austria


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


o.o.


00-203 Warsaw

Poland

Depakine Chrono

500

Sodium valproate,

Valproic acid

333 mg,

145 mg

Prolonged-release

tablet

Oral Use


o.o.


00-203 Warsaw

Poland

Depakine

Chronosphere 100

Sodium valproate,

Valproic acid

(66,66 mg +

29,03

mg)/sachet

Prolonged-release

granules

Oral Use


o.o.


00-203 Warsaw

Poland

Depakine

Chronosphere 1000

Sodium valproate,

Valproic acid

(666,60 mg +

290,27

mg)/sachet

Prolonged-release

granules

Oral Use


o.o.


00-203 Warsaw

Poland

Depakine

Chronosphere 250

Sodium valproate,

Valproic acid

(166,76 mg +

72,61

mg)/sachet

Prolonged-release

granules

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


o.o.


00-203 Warsaw

Poland

Depakine

Chronosphere 500

Sodium valproate,

Valproic acid

(333,30 mg +

145,14

mg)/sachet

Prolonged-release

granules

Oral Use


o.o.


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril 300 retard Sodium Valproate 300 mg Prolonged-release

tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril Long 1000 Sodium Valproate 1000 mg Prolonged-release

tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


capsule

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


capsule

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

Oral Use

Poland Sandoz GmbH

Biochemiestrasse 10

6250 Kundl

Austria

ValproLEK 300 Sodium Valproate 300 mg Prolonged-release

tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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



Empreendimento


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration



Empreendimento


7, 3º Piso, Porto

Salvo

2740-244 Porto

Salvo

Portugal

Depakine Valproic acid 40 mg/ml Syrup Oral Use



Empreendimento


7, 3º Piso, Porto

Salvo

2740-244 Porto

Salvo

Portugal

Depakine Chrono

300


tablet

Oral Use



Empreendimento


7, 3º Piso, Porto

Salvo

2740-244 Porto

Salvo

Portugal

Depakine Chrono

500


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration



Empreendimento


7, 3º Piso, Porto

Salvo

2740-244 Porto

Salvo

Portugal

Depakine

Chronosphere

Valproic acid 750 mg Modified-release

granules

Oral Use



Empreendimento


7, 3º Piso, Porto

Salvo

2740-244 Porto

Salvo

Portugal

Depakine

Chronosphere


granules

Oral Use



Empreendimento


7, 3º Piso, Porto

Salvo

2740-244 Porto

Salvo

Portugal

Depakine

Chronosphere

Valproic acid 500-1000 mg Modified-release

granules

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration



Empreendimento


7, 3º Piso, Porto

Salvo

2740-244 Porto

Salvo

Portugal

Depakine

Chronosphere


granules

Oral Use



Empreendimento


7, 3º Piso, Porto

Salvo

2740-244 Porto

Salvo

Portugal

Depakine

Chronosphere


granules

Oral Use



Empreendimento


7, 3º Piso, Porto

Salvo

2740-244 Porto

Salvo

Portugal

Depakine

Chronosphere

Valproic acid 50-350 mg Modified-release

granules

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration



Empreendimento


7, 3º Piso, Porto

Salvo

2740-244 Porto

Salvo

Portugal

Depakine

Chronosphere


granules

Oral Use



Empreendimento


7, 3º Piso, Porto

Salvo

2740-244 Porto

Salvo

Portugal

Depakine

Chronosphere


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


Técnica

Farmacêutica, S.A.

Rua Tierno Galvan -

Amoreiras - Torre 3

- 12º Lisboa

1099-036 Lisboa

Portugal


capsule, hard

Oral Use


Técnica

Farmacêutica, S.A.

Rua Tierno Galvan -

Amoreiras - Torre 3

- 12º Lisboa

1099-036 Lisboa

Portugal


capsule, hard

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Técnica

Farmacêutica, S.A.

Rua Tierno Galvan -

Amoreiras - Torre 3

- 12º Lisboa

1099-036 Lisboa

Portugal


granules

Oral Use


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


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


tablet

Oral Use

Portugal Generis

Farmacêutica, S.A.

Rua João de Deus,

19 Amadora

2700-487 Amadora

Portugal

Ácido Valpróico

Generis


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


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


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


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


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


capsule, soft

Oral Use

Romania GEROT

PHARMAZEUTIKA

Ges.m.b.H.

Arnethgasse 3

A-1160, Wien

Austria

CONVULEX® 500

mg

Valproic Acid,

Sodium Valproate


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

DEPAKINE 200 mg Valproic Acid,

Sodium Valproate


tablet

Oral Use


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

DEPAKINE CHRONO

300 mg

Valproic Acid,

Sodium Valproate


tablet

Oral Use


FRANCE

1-13, Boulevard

Romain Rolland

75014 Paris

France

DEPAKINE CHRONO

500 mg

Valproic Acid,

Sodium Valproate


tablet

Oral Use

Romania Desitin Arzneimittel

Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

ORFIRIL 150 Valproic Acid,

Sodium Valproate


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


Sodium Valproate


tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


Sodium Valproate


tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

ORFIRIL LONG 150

mg

Valproic Acid,

Sodium Valproate


capsule

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

ORFIRIL LONG 300

mg

Valproic Acid,

Sodium Valproate


capsule

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

ORFIRIL LONG 500

mg

Valproic Acid,

Sodium Valproate


tablet

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

ORFIRIL LONG

1000 mg

Valproic Acid,

Sodium Valproate


tablet

Oral Use


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration

Slovak Republic Orion Corporation

Orionintie 1 A

FI-02200 Espoo

Finland

Absenor 300 mg

tablety s

predĺženým

uvoľňovaním


tablet

oral use

Slovak Republic Orion Corporation

Orionintie 1 A

FI-02200 Espoo

Finland

Absenor 500 mg

tablety s

predĺženým

uvoľňovaním


tablet

oral use

Slovak Republic G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Convulex sodium valproate 50 mg Syrup oral use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex 300

mg/ml kvapky

sodium valproate 300mg/ml Oral drops, solution oral use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex 150 mg

kapsuly

Valproic acid 150 mg Capsule oral use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex 300 mg

kapsuly



Schlossplatz 1

A-8502 Lannach

Austria

Convulex 500 mg

kapsuly



EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Schlossplatz 1

A-8502 Lannach

Austria

Convulex CR 500

mg


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


Slovakia s r.o.

Einsteinova 24

85101 Bratislava

Slovak Republic

Depakine Chrono

500 mg

Valproic Acid, Sodium

Valproate


tablet

oral use


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

oral use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril 600 Sodium Valproate 600mg Gastro-resistant

tablet

oral use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril

Injektionslösung

Sodium Valproate 100 mg/ml Solution for

injection

intravenous use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril long 1000

mg


tablet

oral use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril long 150 mg Sodium Valproate 150 mg Prolonged-release

capsule

oral use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


capsule

oral use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


tablet

oral use

Slovak Republic Ratiopharm GmbH

Graf-Arco-Strasse 3

89079 Ulm

Germany

Valpro-ratiopharm

Chrono 500 mg

Valproid Acid, Sodium

Valproate


tablet

oral use

Slovak Republic Sandoz

Pharmaceuticals d.d

Verovškova 57

1000 Ľubľana

Slovenia

Valproát chrono

Sandoz 300 mg

tablety s

predľženým

uvoľňovaním


Valproate


tablet

oral use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration

Slovak Republic Sandoz

Pharmaceuticals d.d

Verovškova 57

1000 Ľubľana

Slovenia

Valproát chrono

Sandoz 500 mg

tablety s

predľženým

uvoľňovaním


Valproate


tablet

oral use

Slovenia Sanofi-Aventis d.o.o.

Dunajska cesta 151

1000 Ljubljana

Slovenia

Depakine chrono

500 mg tablete s

podaljšanim

sproščanjem


tablet

Oral Use

Slovenia Sanofi-Aventis d.o.o.

Dunajska cesta 151

1000 Ljubljana

Slovenia

Depakine chrono

300 mg tablete s

podaljšanim

sproščanjem


tablet

Oral Use

Spain SANOFI AVENTIS,

S.A.

Josep Plá, 2

08019 Barcelona

Spain

Depakine 200 mg

comprimidos

gastrorresistentes


tablet

Oral Use


S.A.

Josep Plá, 2

08019 Barcelona

Spain

Depakine 500 mg

comprimidos

gastrorresistentes


tablet

Oral Use


S.A.

Josep Plá, 2

08019 Barcelona

Spain

Depakine 200

mg/ml solución oral

Sodium Valproate 200 mg/ml Oral solution Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


for solution for

injection

Intravenous Use


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


Orionintie 1 A

FI-02200 Espoo

Finland

Absenor® sodium valproate 300 mg Tablet Oral Use


Orionintie 1 A

FI-02200 Espoo

Finland

Absenor® sodium valproate 100 mg Gastro-resistant

tablet

Oral Use


Orionintie 1 A

FI-02200 Espoo

Finland


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Orionintie 1 A

FI-02200 Espoo

Finland


tablet

Oral Use


Orionintie 1 A

FI-02200 Espoo

Finland

Absenor® sodium valproate 60 mg/ml Oral solution Oral Use


Orionintie 1 A

FI-02200 Espoo

Finland

Absenor® Depot sodium valproate 500 mg Prolonged-release

tablet

Oral Use


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


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril sodium valproate 300 mg Gastro-resistant

tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Orfiril long sodium valproate 150 mg Prolonged-release

capsule, hard

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


capsule, hard

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


granules

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany


granules

Oral Use

Sweden sanofi-aventis AB

Box 14142

167 14 Bromma

Sweden

Ergenyl sodium valproate 200 mg/ml Oral drops, solution Oral Use


EMA/678403/2013 /144

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EEA

Marketing

authorisaton

holder


form

Route of

administration


Box 14142

167 14 Bromma

Sweden

Ergenyl sodium valproate 100 mg Gastro-resistant

tablet

Oral Use


Box 14142

167 14 Bromma

Sweden


tablet

Oral Use


Box 14142

167 14 Bromma

Sweden


tablet

Oral Use


Box 14142

167 14 Bromma

Sweden

Ergenyl sodium valproate 60 mg/ml Oral solution Oral Use


Box 14142

167 14 Bromma

Sweden

Ergenyl sodium valproate 400 mg Powder and solvent

for solution for

injection

Oral Use


Box 14142

167 14 Bromma

Sweden

Ergenyl Retard sodium valproate 100 mg Prolonged-release

tablet

Oral Use


Box 14142

167 14 Bromma

Sweden


tablet

Oral Use


EMA/678403/2013 /144

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EEA

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authorisaton

holder


form

Route of

administration


Box 14142

167 14 Bromma

Sweden


tablet

Oral Use


Box 14142

167 14 Bromma

Sweden


granules in sachet

Oral Use


Box 14142

167 14 Bromma

Sweden


granules in sachet

Oral Use


Box 14142

167 14 Bromma

Sweden


granules in sachet

Oral Use


Box 14142

167 14 Bromma

Sweden


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


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


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


Netherlands B.V.

Kampenringweg 45

D-E

2803 PE GOUDA

The Netherlands

Depakine Enteric,

maagsapresistente

tabletten 150 mg


tablet

Oral Use


Netherlands B.V.

Kampenringweg 45

D-E

2803 PE GOUDA

The Netherlands

Depakine Enteric,

maagsapresistente

tabletten 300 mg


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Netherlands B.V.

Kampenringweg 45

D-E

2803 PE GOUDA

The Netherlands

Depakine Enteric,

maagsapresistente

tabletten 500 mg


tablet

Oral Use


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


Netherlands B.V.

Kampenringweg 45

D-E

2803 PE GOUDA

The Netherlands

Depakine

suikervrije stroop,

drank 200 mg/5 ml



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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Netherlands B.V.

Kampenringweg 45

D-E

2803 PE GOUDA

The Netherlands

Natrii valproas,

maagsapresistente

tabletten 300 mg


tablet

Oral Use

The Netherlands Apotex Europe B.V.

Darwinweg 20

2333 CR LEIDEN

The Netherlands

Natriumvalproaat

Apotex 150 mg,

maagsapresistente

tabletten


tablet

Oral Use


Darwinweg 20

2333 CR LEIDEN

The Netherlands

Natriumvalproaat

Apotex 300 mg,

maagsapresistente

tabletten


tablet

Oral Use


Darwinweg 20

2333 CR LEIDEN

The Netherlands

Natriumvalproaat

Apotex 300 mg/5

ml, drank



Darwinweg 20

2333 CR LEIDEN

The Netherlands

Natriumvalproaat

Apotex 600 mg,

maagsapresistente

tabletten


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


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


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


Swensweg 5

2031 GA HAARLEM

The Netherlands

Orfiril CR 150 mg,

capsules met

gereguleerde

afgifte


capsule, hard

Oral Use


Swensweg 5

2031 GA HAARLEM

The Netherlands

Orfiril CR 300 mg,

capsules met

gereguleerde

afgifte


capsule, hard

Oral Use


Swensweg 5

2031 GA HAARLEM

The Netherlands

Orfiril CR 500 mg,

granulaat met

gereguleerde

afgifte


granules

Oral Use


Swensweg 5

2031 GA HAARLEM

The Netherlands

Orfiril 100 mg/ml,

oplossing voor

injectie

sodium valproate 100 mg/ml Solution for

injection

Intravenous Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Darwinweg 20

2333 CR LEIDEN

The Netherlands

Propymal Enteric

150 mg,

maagsapresistente

capsules


capsule

Oral Use


Darwinweg 20

2333 CR LEIDEN

The Netherlands

Propymal Enteric

300 mg,

maagsapresistente

capsules


capsule

Oral Use


Darwinweg 20

2333 CR LEIDEN

The Netherlands

Propymal Enteric

450 mg,

maagsapresistente

capsules


capsule

Oral Use


Darwinweg 20

2333 CR LEIDEN

The Netherlands

Propymal Enteric

600 mg,

maagsapresistente

capsules


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


Limited

One Onslow Street

Guildford, Surrey

GU1 4SY

UK

Depakote 500mg

Tablets

Valproate Semisodium 538.2 mg Gastro-resistant

tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Limited

One Onslow Street

Guildford, Surrey

GU1 4SY

UK

Epilim Liquid Sodium Valproate 200 mg / 5 ml Oral solution Oral Use


Limited

One Onslow Street

Guildford, Surrey

GU1 4SY

UK

Epilim Syrup

200mg/5ml



Limited

One Onslow Street

Guildford, Surrey

GU1 4SY

UK

Epilim 200 Gastro-

Resistant Tablets


tablet

Oral Use


Limited

One Onslow Street

Guildford, Surrey

GU1 4SY

UK

Epilim 500 Gastro-

Resistant Tablets


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


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


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


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


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


Limited

One Onslow Street

Guildford, Surrey

GU1 4SY

UK

Epilim 100mg

Crushable Tablet

Sodium Valproate 100 mg Tablet Oral Use


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


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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


tablet

Oral Use

United Kingdom Norton Healthcare

Limited

Ridings Point,

Whistler Drive

Castleford

WF10 5HX

United Kingdom

Sodium Valproate

Oral solution BP

200mg/5ml


United Kingdom Generics UK Limited

Station Close,

Potter's Bar

Hertfordshire

EN6 1TL

United Kingdom

Sodium Valproate

Tablets 200mg


United Kingdom Generics UK Limited

Station Close,

Potter's Bar

Hertfordshire

EN6 1TL

United Kingdom

Sodium Valproate

Tablets BP 500mg

EC



EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration

United Kingdom Desitin Arzneimittel

Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Episenta 150mg

Prolonged-release

capsules


capsule

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Episenta 300mg

Prolonged-release

capsules


capsule

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Episenta 500mg

Prolonged-release

Granules


granules

Oral Use


Gmbh

Weg beim Jaeger

214

DE-22335 Hamburg

Germany

Episenta 1000mg

Prolonged-release

Granules


granules

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


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


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


tablet

Oral Use

United Kingdom Winthrop

Pharmaceuticals UK

Limited

One Onslow Street

Guildford, Surrey

GU1 4YS

United Kingdom

Sodium valproate

liquid 200mg/5ml



Pharmaceuticals UK

Limited

One Onslow Street

Guildford, Surrey

GU1 4YS

United Kingdom

Sodium valproate

200mg gastro-

resistant tablets


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


form

Route of

administration


Pharmaceuticals UK

Limited

One Onslow Street

Guildford, Surrey

GU1 4YS

United Kingdom

Sodium valproate

500mg gastro-

resistant tablets


tablet

Oral Use

United Kingdom G.L. Pharma GmbH

Schlossplatz 1

A-8502 Lannach

Austria

Convulex Capsules

300mg


capsule

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex Capsules

500mg


capsule

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Convulex Capsules

150mg


capsule

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Epival CR 300mg

prolonged-release

tablets


tablet

Oral Use


Schlossplatz 1

A-8502 Lannach

Austria

Epival CR 500mg

prolonged-release

tablets


tablet

Oral Use


EMA/678403/2013 /144

Member State in

EEA

Marketing

authorisaton

holder


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



Limited

Ash Road North

Wrexham Industrial

Estate

Wrexham, LL13 9UF

United Kingdom

Orlept 200mg

gastro-resistant

tablets


tablet

Oral Use


Limited

Ash Road North

Wrexham Industrial

Estate

Wrexham, LL13 9UF

United Kingdom

Orlept 500mg

gastro-resistant

tablets


tablet

Oral Use


Limited

Ash Road North

Wrexham Industrial

Estate

Wrexham, LL13 9UF

United Kingdom

Sodium valproate

100mg/ml solution

for injection or

infusion


injection/infusion

Intravenous Use

Valproate - Art 31 - 1387 - Annex I for publication · DEPAKINE CHRONO 300 mg filmom obložene...

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Transcript of Valproate - Art 31 - 1387 - Annex I for publication · DEPAKINE CHRONO 300 mg filmom obložene...