EN Official Journal of the European Union C 295/17

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2010 to 31 August 2010

(Decisions taken pursuant to Article 34 of Directive 2001/83/EC (1) or Article 38 of Directive 2001/82/EC (2))

2010/C 295/02

— Issuing, maintenance or modification of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 16.8.2010 Porcilis M Hyo and associated names See Annex I See Annex I 17.8.2010 16.8.2010 Porcilis PRRS and associated names See Annex II See Annex II 17.8.2010 7.7.2010 Levact and associated names See Annex III See Annex III 9.7.2010 26.8.2010 Valproic acid/valproate See Annex IV See Annex IV 30.8.2010 1.7.2010 Gadolinium See Annex V See Annex V 5.7.2010 13.7.2010 Valtrex and associated names See Annex VI See Annex VI 16.7.2010 27.7.2010 Famvir and associated names See Annex VII See Annex VII 28.7.2010 7.7.2010 Vascace See Annex VIII See Annex VIII 8.7.2010 13.7.2010 Atacand and associated names See Annex IX See Annex IX 16.7.2010 1.7.2010 Sortis See Annex X See Annex X 6.7.2010 1.7.2010 Quinolones and Fluoroquinolones See Annex XI See Annex XI 6.7.2010 26.8.2010 Seroquel XR and associated names See Annex XII See Annex XII 30.8.2010 27.7.2010 Tiamutin premix and associated names See Annex XIII See Annex XIII 28.7.2010 5.7.2010 Daxas Nycomed GmbH, Byk-Gulden-Str. 2, D-78467 Konstanz, Deutschland These Decisions are addressed to the Member States 7.7.2010 27.7.2010 Leflunomide medac medac Gesellschaft für klinische Spezialpräparate mbH, Fehlandtstrasse 3, D-20354 Hamburg, Deutschland These Decisions are addressed to the Member States 29.7.2010 27.7.2010 Ozurdex Allergan Pharmaceuticals (Ireland) Ltd, Castlebar Road, Westport, Co. Mayo, Ireland These Decisions are addressed to the Member States 28.7.2010 1.7.2010 Retacrit HOSPIRA Enterprises B.V., Taurusavenue 19-21, 2132 LS HOOFDDORP, Nederland These Decisions are addressed to the Member States 9.7.2010 1.7.2010 Silapo STADA Arzneimittel AG, Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland These Decisions are addressed to the Member States 5.7.2010 5.7.2010 Thelin Encysive (UK) Limited, Alder Castle House, 10 Noble Street, London EC2V 7QJ, United Kingdom These Decisions are addressed to the Member States 7.7.2010





— Refusal of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 22.7.2010 Ciclosporin IDL See Annex XIV See Annex XIV 29.7.2010





— Suspension of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 22.7.2010 Ciclosporin IDL See Annex XIV See Annex XIV 29.7.2010 6.8.2010 Sibutramine See Annex XV See Annex XV 10.8.2010 22.7.2010 Tildren See Annex XVI See Annex XVI 23.7.2010





— Revocation of a national marketing authorization

Date of the decision Name(s) of the medicinal product Holder(s) of the marketing authorization Member State concerned Date of notification 27.7.2010 Bufexamac See Annex XVII See Annex XVII 29.7.2010

(1) OJ L 311, 28.11.2001, p. 67.

(2) OJ L 311, 28.11.2001, p. 1.

ANNEX I LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, WITHDRAWAL PERIOD, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State/EEA Marketing Authorisation Holder Product name Strength Pharmaceutical form Animal species Indications Withdrawal period Austria Intervet GmbH Siemensstrasse 107 1210 Wien Austria PORCILIS M HYO Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Belgium Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands PORCILIS M HYO Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Cyprus Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands PORCILIS M. HYO Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Czech Republic Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Porcilis M HYO Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Denmark Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Porcilis M Hyo Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Estonia Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Porcilis M Hyo Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Finland Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Porcilis M Hyo Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days France Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands PORCILIS M hyo Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Germany Intervet Deutschland GmbH Postfach 1130 85701 Unterschleißheim Germany Porcilis M Hyo Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Greece Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands PORCILIS M.Hyo Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Hungary Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Porcilis M Hyo Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Ireland Intervet Ireland Limited, Magna Drive Magna Business Park Citywest Road Dublin 24 Ireland Porcilis M Hyo, suspension for injection Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Italy Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Porsilis M-HYO Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Latvia Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands PORCILIS M HYO Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Lithuania Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Porcilis M Hyo Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Luxembourg Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Porcilis M. Hyo, suspension injectable Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Malta Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Porcilis M Hyo Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Norway Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands PORCILIS M HYO Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Poland Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Porcilis M Hyo Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Portugal Intervet Portugal – Saúde Animal, Lda Rua Agualva dos Açores, n.o 16, 2735–557 Agualva-Cacém Portugal Porcilis M hyo, suspensão para injecção Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Slovakia Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Porcillis M.Hyo Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Slovenia Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Porcilis M Hyo Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Spain POLIG. INDUSTRIAL EL MONTALVO, PARCELA 39 CARBAJOSA DE LA SAGRADA 37188 SALAMANCA Spain PORCILIS M hyo Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days Sweden Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Porcilis M Hyo Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days The Netherlands Intervet International bv Wim de Koerverstraat 35 5831 AN Boxmeer The Netherlands Porcilis M Hyo Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days United Kingdom Intervet International B.V. represented by Intervet UK Ltd Walton Manor Walton Milton Keynes Bucks MK7 7AJ Porcilis M Hyo, suspension for injection Inactivated whole cell concentrate of Mycoplasma hyopneumoniae strain 11: ≥ 7.0 log2 Ab titre Suspension for injection Pigs (finishing pigs) For the active immunisation of pigs to reduce pulmonary lesions due to infection by Mycoplasma hyopneumoniae. Zero days

ANNEX II LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTES OF ADMINISTRATION, WITHDRAWAL PERIOD, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State/EEA Marketing Authorisation Holder Product name Strength Pharmaceutical form Animal species Indications Withdrawal period Austria Intervet GmbH Siemensstrasse 107 1210 Wien Austria Porcilis PRRS live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose Lyophilisate and solvent for suspension for injection Pigs For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus Zero days Belgium Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands PORCILIS PRRS live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose Lyophilisate and solvent for suspension for injection Pigs For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus Zero days France INTERVET RUE OLIVIER DE SERRES ANGERS TECHNOPOLE 49071 BEAUCOUZE France PORCILIS PRRS IM live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose Lyophilisate and solvent for suspension for injection Pigs For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus Zero days Germany Intervet Deutschland GmbH Postfach 1130 85701 Unterschleißheim Germany Porcilis PRRS live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose Lyophilisate and solvent for suspension for injection Pigs For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus Zero days Greece Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands PORCILIS PRRS live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose Lyophilisate and solvent for suspension for injection Pigs For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus Zero days Ireland Intervet Ireland Limited Magna Drive Magna Business Park Citywest Road Dublin 24 Ireland Porcilis PRRS IM live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose Lyophilisate and solvent for suspension for injection Pigs For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus Zero days Ireland Intervet Ireland Limited Magna Drive Magna Business Park Citywest Road Dublin 24 Ireland Porcilis PRRS IDAL live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose Lyophilisate and solvent for suspension for injection Pigs For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus Zero days Italy Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Porsilis PRRS live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose Lyophilisate and solvent for suspension for injection Pigs For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus Zero days Luxembourg Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands PORCILIS PRRS live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose Lyophilisate and solvent for suspension for injection Pigs For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus Zero days Portugal Intervet Portugal – Saúde Animal, Lda Rua Agualva dos Açores, n.o 16, 2735 – 557 Agualva-Cacém Portugal PORCILIS PRSS live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose Lyophilisate and solvent for suspension for injection Pigs For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus Zero days Spain Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands PORCILIS PRSS live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose Lyophilisate and solvent for suspension for injection Pigs For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus Zero days The Netherlands Intervet International BV Wim de Körverstraat 35 5831 AN Boxmeer The Netherlands Porcilis PRRS live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose Lyophilisate and solvent for suspension for injection Pigs For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus Zero days United Kingdom Intervet UK Ltd. Walton Manor, Walton Milton Keynes, Bucks MK7 7AJ United Kingdom Porcilis PRRS live attenuated PRRS virus strain DV: 104.0 - 106.3 TCID50 per dose Lyophilisate and solvent for suspension for injection Pigs For active immunisation of clinically healthy pigs in a PRRS virus contaminated environment, to reduce viraemia caused by infection with European strains of PRRS virus Zero days

ANNEX III LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTE OF ADMINISTRATION, APPLICANTS IN THE MEMBER STATES Member State EU/EEA Applicant company name, address (Invented) Name Strength Pharmaceutical Form Route of administration Austria Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München Germany Levact 2,5 mg/ml Pulver für ein Konzentrat zur Herstellung einer Infusionslösung 2,5 mg/ml Powder for concentrate for solution for infusion Intravenous use Belgium Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München Germany Levact 2,5 mg/ml Powder for concentrate for solution for infusion Intravenous use Denmark Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München Germany Ribomustin 2,5 mg/ml Powder for concentrate for solution for infusion Intravenous use Finland Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München Germany Ribomustin 2,5 mg/ml Powder for concentrate for solution for infusion Intravenous use France Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München Germany Levact 2,5 mg/ml Powder for concentrate for solution for infusion Intravenous use Germany Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München Germany Levact 2,5 mg/ml Powder for concentrate for solution for infusion Intravenous use Ireland Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München Germany Levact 2,5 mg/ml Powder for concentrate for solution for infusion Intravenous use Italy Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München Germany Ribomustin 2,5 mg/ml Powder for concentrate for solution for infusion Intravenous use Luxembourg Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München Germany Levact 2,5 mg/ml Powder for concentrate for solution for infusion Intravenous use Norway Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München Germany Levact 2,5 mg/ml Powder for concentrate for solution for infusion Intravenous use Poland Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München Germany Levact 2,5 mg/ml Powder for concentrate for solution for infusion Intravenous use Spain Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München Germany Levact 2,5 mg/ml Powder for concentrate for solution for infusion Intravenous use United Kingdom Astellas Pharma GmbH Georg-Brauchle-Ring 64 - 66 80992 München Germany Ribomustin 2,5 mg/ml Powder for concentrate for solution for infusion Intravenous use

ANNEX IV LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES Member State Marketing Authorisation Holder Product Name Strength Pharmaceutical Form Route of administration Austria Gerot Pharmazeutika G.m.b.H Arnethgasse 3 A-1160 Wien Austria Convulex 150 mg - Kapseln 150 mg gastro-resistant capsule, soft Oral Use Austria Gerot Pharmazeutika G.m.b.H Arnethgasse 3 A-1160 Wien Austria Convulex 200 mg - Kapseln 200 mg gastro-resistant capsule, soft Oral Use Austria Gerot Pharmazeutika G.m.b.H Arnethgasse 3 A-1160 Wien Austria Convulex 300 mg - Kapseln 300 mg gastro-resistant capsule, soft Oral Use Austria Gerot Pharmazeutika G.m.b.H Arnethgasse 3 A-1160 Wien Austria Convulex 300 mg - Filmtabletten 300 mg film-coated tablet Oral Use Austria Gerot Pharmazeutika G.m.b.H Arnethgasse 3 A-1160 Wien Austria Convulex 500 mg - Kapseln 500 mg gastro-resistant capsule, soft Oral Use Austria Gerot Pharmazeutika G.m.b.H Arnethgasse 3 A-1160 Wien Austria Convulex 50 mg/ml - Sirup für Kinder 50 mg/ml syrup Oral Use Austria Gerot Pharmazeutika G.m.b.H Arnethgasse 3 A-1160 Wien Austria Convulex 300 mg/ml - Lösung zum Einnehmen 300 mg/ml oral solution Oral Use Austria Gerot Pharmazeutika G.m.b.H Arnethgasse 3 A-1160 Wien Austria Convulex 300 mg - Retardtabletten 300 mg prolonged-release tablet Oral Use Austria Gerot Pharmazeutika G.m.b.H Arnethgasse 3 A-1160 Wien Austria Convulex 500 mg - Retardtabletten 500 mg prolonged-release tablet Oral Use Austria Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien Austria Depakine chrono retard 300 mg - Filmtabletten 300 mg prolonged-release tablet Oral Use Austria Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien Austria Depakine chrono retard 500 mg - Filmtabletten 500 mg prolonged-release tablet Oral Use Austria Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien Austria Depakine Chronosphere 500-1 000 mg/Dosis - Retardgranulat 500 -1 000 mg prolonged-release granules Oral Use Austria Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien Austria Depakine Chronosphere 50-200 mg/Dosis - Retardgranulat 50 - 200 mg prolonged-release granules Oral Use Austria Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien Austria Depakine Chronosphere 50-350 mg/Dosis - Retardgranulat 50 - 350 mg prolonged-release granules Oral Use Austria Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien Austria Depakine Chronosphere 100 mg - Retardgranulat in Beuteln 100 mg prolonged-release granules Oral Use Austria Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien Austria Depakine Chronosphere 1 000 mg - Retardgranulat in Beuteln 1 000 mg prolonged-release granules Oral Use Austria Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien Austria Depakine Chronosphere 250 mg - Retardgranulat in Beuteln 250 mg prolonged-release granules Oral Use Austria Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien Austria Depakine Chronosphere 50 mg - Retardgranulat in Beuteln 50 mg prolonged-release granules Oral Use Austria Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien Austria Depakine Chronosphere 500 mg - Retardgranulat in Beuteln 500 mg prolonged-release granules Oral Use Austria Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien Austria Depakine Chronosphere 750 mg - Retardgranulat in Beuteln 750 mg prolonged-release granules Oral Use Austria Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien Austria Depakine 300 mg - Filmtabletten 300 mg film-coated tablet Oral Use Austria Sanofi-aventis GmbH SATURN Tower, Leonard-Bernstein-Str. 10 Vienna DC, A-1220 Wien Austria Depakine 300 mg/ml - Tropfen 300 mg/ml oral drops, solution Oral Use Austria Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-G. 3 A-1140 Wien Austria Natriumvalproat ‘ratiopharm’ retard 300 mg - Filmtabletten 300 mg prolonged-release tablet Oral Use Austria Ratiopharm Arzneimittel Vertriebs-GmbH Albert-Schweitzer-G. 3 A-1140 Wien Austria Natriumvalproat ‘ratiopharm’ retard 500 mg - Filmtabletten 500 mg prolonged-release tablet Oral Use Austria G. L. Pharma GmbH Schloßplatz 1 8502 Lannach Austria Natriumvalproat G.L. 300 mg - Retardtabletten 300 mg prolonged-release tablet Oral Use Austria G. L. Pharma GmbH Schloßplatz 1 8502 Lannach Austria Natriumvalproat G.L. 500 mg - Retardtabletten 500 mg prolonged-release tablet Oral Use Belgium NYCOMED BELGIUM N.V. Gentsesteenweg 615 1080 Brussels Belgium CONVULEX 50 mg/ml syrup Oral Use Belgium NYCOMED BELGIUM N.V. Gentsesteenweg 615 1080 Brussels Belgium CONVULEX 300 300 mg gastro-resistant capsule, hard Oral Use Belgium NYCOMED BELGIUM N.V. Gentsesteenweg 615 1080 Brussels Belgium CONVULEX 500 500 mg gastro-resistant capsule, hard Oral Use Belgium NYCOMED BELGIUM N.V. Gentsesteenweg 615 1080 Brussels Belgium CONVULEX-150 150 mg gastro-resistant capsule, hard Oral Use Belgium SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1 C 1831 Diegem Belgium DEPAKINE 300 mg/ml oral drops, solution Oral Use Belgium SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1 C 1831 Diegem Belgium DEPAKINE 300 MG/5 ML 300 mg/5 ml syrup Oral Use Belgium SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1 C 1831 Diegem Belgium DEPAKINE CHRONO 300 200,00 mg/87,00 mg prolonged- release tablet Oral Use Belgium SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1 C 1831 Diegem Belgium DEPAKINE CHRONO 500 333,00 mg/145,00 mg prolonged- release tablet Oral Use Belgium SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1 C 1831 Diegem Belgium DEPAKINE CHRONO MICROGRANULES 0,33 G/G 220,00 mg/g/96,00 mg/g prolonged-release granules Oral Use Belgium SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1 C 1831 Diegem Belgium DEPAKINE ENTERIC 150 150 mg gastro-resistant tablet Oral Use Belgium SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1 C 1831 Diegem Belgium DEPAKINE ENTERIC 300 300 mg gastro-resistant tablet Oral Use Belgium SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1 C 1831 Diegem Belgium DEPAKINE ENTERIC 500 500 mg gastro-resistant tablet Oral Use Belgium SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1 C 1831 Diegem Belgium DEPAKOTE 250 269,10 mg gastro-resistant tablet Oral Use Belgium SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1 C 1831 Diegem Belgium DEPAKOTE 500 538,20 mg gastro-resistant tablet Oral Use Belgium SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1 C 1831 Diegem Belgium DEPAMIDE 300 mg gastro-resistant tablet Oral Use Belgium EUROGENERICS N.V. Heizel Esplanade b22 1020 Laken Belgium VALPROATE RETARD EG 300 MG 200,00 mg/87,00 mg prolonged- release tablet Oral Use Belgium EUROGENERICS N.V. Heizel Esplanade b22 1020 Laken Belgium VALPROATE RETARD EG 500 MG 333,00 mg/145,00 mg prolonged- release tablet Oral Use Belgium MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium VALPROATE RETARD MYLAN 300 MG 300 mg prolonged- release tablet Oral Use Belgium MYLAN BVBA/SPRL Terhulpsesteenweg 6A 1560 Hoeilaart Belgium VALPROATE RETARD MYLAN 500 MG 500 mg prolonged- release tablet Oral Use Belgium SANDOZ N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium VALPROATE SANDOZ 300 MG 199,80 mg/87,00 mg prolonged- release tablet Oral Use Belgium SANDOZ N.V. Telecom Gardens Medialaan 40 1800 Vilvoorde Belgium VALPROATE SANDOZ 500 MG 333,00 mg/145,00 mg prolonged- release tablet Oral Use Belgium SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1 C 1831 Diegem Belgium VALPROIM CHRONO 300 200,00 mg/87,00 mg prolonged- release tablet Oral Use Belgium SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1 C 1831 Diegem Belgium VALPROIM CHRONO 500 333,00 mg/145,00 mg prolonged- release tablet Oral Use Belgium SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1 C 1831 Diegem Belgium VALPROIM LA 300 300,00 mg gastro-resistant tablet Oral Use Belgium SANOFI-AVENTIS BELGIUM N.V. Culliganlaan 1 C 1831 Diegem Belgium VALPROIM LA 500 500,00 mg gastro-resistant tablet Oral Use Belgium Kristina De Turck KDT Consulting Chaussée de Ninove 2 1540 Herne Belgium VALPROSTAT 300 MG 199,80 mg/87,00 mg prolonged- release tablet Oral Use Belgium Kristina De Turck KDT Consulting Chaussée de Ninove 2 1540 Herne Belgium VALPROSTAT 500 MG 333,00 mg/145,00 mg prolonged- release tablet Oral Use Bulgaria AWD. pharma GmbH & Co. KG Wasastr. 50 D-01445 Radebeul Germany Convulsofin 333 mg tablet Oral Use Bulgaria G.L.Pharma GmbH Schlossplatz 1, A-8502 Lannach, Austria Convulex chrono 500 mg prolonget-release tablet Oral Use Bulgaria G.L.Pharma GmbH Schlossplatz 1 A-8502 Lannach Austria Convulex chrono 300 mg prolonget-release tablet Oral Use Bulgaria G.L.Pharma GmbH Schlossplatz 1 A-8502 Lannach Austria Convulex 500 mg gastro-resistant capsule Oral Use Bulgaria G.L.Pharma GmbH Schlossplatz 1 A-8502 Lannach Austria Convulex 150 mg gastro-resistant capsule Oral Use Bulgaria G.L.Pharma GmbH Schlossplatz 1 A-8502 Lannach Austria Convulex 300 mg gastro-resistant capsule Oral Use Bulgaria G.L.Pharma GmbH Schlossplatz 1 A-8502 Lannach Austria Convulex 50 mg/ml syrup Oral Use Bulgaria Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България Bulgaria Depakine Chrono 300 mg prolonged release tablet Oral Use Bulgaria Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България Bulgaria Depakine Chrono 500 mg prolonged release tablet Oral Use Bulgaria Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България Bulgaria Depakine 5,764 g/100 ml syrup Oral Use Bulgaria Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България Bulgaria Depakine 200 mg gastro-resistant tablet Oral Use Bulgaria Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България Bulgaria Depakine 500 mg gastro-resistant tablet Oral Use Bulgaria Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България Depakine chronosphere 250 mg modified-release granules Oral Use Bulgaria Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България Depakine chronosphere 100 mg modified-release granules Oral Use Bulgaria Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България Depakine chronosphere 1 000 mg modified-release granules Oral Use Bulgaria Санофи-Авентис България ЕООД бул. Ал. Стамболийски 103, офис сграда София Тауър ет.8, София 1303, България Depakine chronosphere 500 mg modified-release granules Oral Use Cyprus Sanofi-Aventis Cyprus Ltd Charalambou Mouskou 14 2015 Strovolos Cyprus DEPAKINE CHRONO 500 mg tablet Oral Use Cyprus Sanofi-Aventis Cyprus Ltd Charalambou Mouskou 14 2015 Strovolos Cyprus DEPAKINE CHRONOSPHERE 50 mg modified-release granules Oral Use Cyprus Sanofi-Aventis Cyprus Ltd Charalambou Mouskou 14 2015 Strovolos Cyprus DEPAKINE CHRONOSPHERE 100 mg modified-release granules Oral Use Cyprus Sanofi-Aventis Cyprus Ltd Charalambou Mouskou 14 2015 Strovolos Cyprus DEPAKINE CHRONOSPHERE 250 mg modified-release granules Oral Use Cyprus Sanofi-Aventis Cyprus Ltd Charalambou Mouskou 14 2015 Strovolos Cyprus DEPAKINE CHRONOSPHERE 500 mg modified-release granules Oral Use Cyprus Sanofi-Aventis Cyprus Ltd Charalambou Mouskou 14 2015 Strovolos Cyprus DEPAKINE CHRONOSPHERE 750 mg modified-release granules Oral Use Cyprus Sanofi-Aventis Cyprus Ltd Charalambou Mouskou 14 2015 Strovolos Cyprus DEPAKINE CHRONOSPHERE 1 000 mg modified-release granules Oral Use Cyprus Remedica Ltd Aharnon street P.O. Box 51706 3508 Lemesos Cyprus PETILIN 500 mg gastro-resistant tablet Oral Use Cyprus Remedica Ltd Aharnon street P.O. Box 51706 3508 Lemesos Cyprus PETILIN 200 mg/5 ml syrup Oral Use Czech Republic Orion Corporation Orionintie 1 FI-02200 Espoo Finland Absenor 300 mg 300 mg prolonged-release tablet Oral Use Czech Republic Orion Corporation Orionintie 1 FI-02200 Espoo Finland Absenor 500 mg 500 mg prolonged-release tablet Oral Use Czech Republic sanofi-aventis, s.r.o. Hadovka Office Park Evropská 846/176a 160 00 Praha 6 Czech Republic DEPAKINE 5,764/100 ml syrup Oral Use Czech Republic G.L. Pharma GmbH Schlossplatz 1 8502 Lannach Austria CONVULEX 300 mg/ml 300 mg/1 ml of drops oral drops, solution Oral Use Czech Republic G.L. Pharma GmbH Schlossplatz 1 8502 Lannach Austria CONVULEX 50 mg/ml syrup Oral Use Czech Republic G.L. Pharma GmbH Schlossplatz 1 8502 Lannach Austria CONVULEX CR 300 mg 300 mg prolonged-release tablet Oral Use Czech Republic G.L. Pharma GmbH Schlossplatz 1 8502 Lannach Austria CONVULEX CR 500 mg 500 mg prolonged-release tablet Oral Use Czech Republic G.L. Pharma GmbH Schlossplatz 1 8502 Lannach Austria CONVULEX 150 150 mg capsule, soft Oral Use Czech Republic G.L. Pharma GmbH Schlossplatz 1 8502 Lannach Austria CONVULEX 300 300 mg capsule, soft Oral Use Czech Republic G.L. Pharma GmbH Schlossplatz 1 8502 Lannach Austria CONVULEX 500 500 mg capsule, soft Oral Use Czech Republic sanofi-aventis, s.r.o. Hadovka Office Park Evropská 846/176a 160 00 Praha 6 Czech Republic DEPAKINE CHRONO 500 mg sécable 500 mg (333 mg/145 mg) modified-release tablet Oral Use Czech Republic sanofi-aventis, s.r.o. Hadovka Office Park Evropská 846/176a 160 00 Praha 6 Czech Republic DEPAKINE CHRONO 300 mg sécable 300 mg (199,8 mg/87 mg) modified-release tablet Oral Use Czech Republic Desitin Arzneimittel GmbH, Weg beim Jäger 214 D-22335 Hamburg Germany Orfiril 150 150 mg gastro-resistant tablet Oral Use Czech Republic Desitin Arzneimittel GmbH, Weg beim Jäger 214 D-22335 Hamburg Germany Orfiril 300 300 mg gastro-resistant tablet Oral Use Czech Republic Desitin Arzneimittel GmbH, Weg beim Jäger 214 D-22335 Hamburg Germany Orfiril 600 600 mg gastro-resistant tablet Oral Use Czech Republic Desitin Arzneimittel GmbH, Weg beim Jäger 214 D-22335 Hamburg Germany Orfiril long 150 mg 150 mg prolonged-release capsule, hard Oral Use Czech Republic Desitin Arzneimittel GmbH, Weg beim Jäger 214 D-22335 Hamburg Germany Orfiril long 300 mg 300 mg prolonged-release capsule, hard Oral Use Czech Republic Desitin Arzneimittel GmbH, Weg beim Jäger 214 D-22335 Hamburg Germany Orfiril long 500 mg 500 mg prolonged-release tablet Oral Use Czech Republic Desitin Arzneimittel GmbH, Weg beim Jäger 214 D-22335 Hamburg Germany Orfiril long 1 000 mg 1 000 mg prolonged-release tablet Oral Use Czech Republic SANDOZ GmbH Biochemiestrasse 10 A-6250 Kundl Austria Valproat Chrono Sandoz 300 mg 300 mg (200 mg/87 mg) prolonged-release tablet Oral Use Czech Republic SANDOZ GmbH Biochemiestrasse 10 A-6250 Kundl Austria Valproat Chrono Sandoz 500 mg 500 mg (333 mg/145 mg) prolonged-release tablet Oral Use Czech Republic sanofi-aventis, s.r.o. Hadovka Office Park Evropská 846/176a 160 00 Praha 6 Czech Republic DEPAKINE CHRONOSPHERE 500 MG 500 mg (333,30 mg/145,14 mg) Modified-release granules Oral Use Czech Republic ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany Valproat-ratiopharm Chrono 300 mg 300 mg (200 mg/87 mg) prolonged-release tablet Oral Use Czech Republic ratiopharm GmbH Graf-Arco-Straße 3 89079 Ulm Germany Valproat-ratiopharm Chrono 500 mg 500 mg (333 mg/145 mg) prolonged-release tablet Oral Use Denmark Sanofi-aventis Denmark A/S Slotsmarken 13 DK-2970 Hørsholm Denmark Deprakine 100 mg gastro-resistant tablet Oral Use Denmark Sanofi-aventis Denmark A/S Slotsmarken 13 DK-2970 Hørsholm Denmark Deprakine 300 mg gastro-resistant tablet Oral Use Denmark Sanofi-aventis Denmark A/S Slotsmarken 13 DK-2970 Hørsholm Denmark Deprakine 500 mg gastro-resistant tablet Oral Use Denmark Sanofi-aventis Denmark A/S Slotsmarken 13 DK-2970 Hørsholm Denmark Deprakine 200 mg/ml oral drops Oral Use Denmark Sanofi-aventis Denmark A/S Slotsmarken 13 DK-2970 Hørsholm Denmark Deprakine 60 mg/ml oral solution Oral Use Denmark Sanofi-aventis Denmark A/S Slotsmarken 13 DK-2970 Hørsholm Denmark Deprakine Retard 300 mg gastro-resistant tablet Oral Use Denmark Sanofi-aventis Denmark A/S Slotsmarken 13 DK-2970 Hørsholm Denmark Deprakine Retard 500 mg gastro-resistant tablet Oral Use Denmark Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Germany Orfiril 60 mg/ml oral solution Oral Use Denmark Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Germany Orfiril 300 mg gastro-resistant tablet Oral Use Denmark Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Germany Orfiril 600 mg gastro-resistant tablet Oral Use Denmark Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Germany Orfiril Long 150 mg prolonged-release capsule Oral Use Denmark Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Germany Orfiril Long 300 mg prolonged-release capsule Oral Use Denmark Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Germany Orfiril Long 500 mg prolonged-release granules Oral Use Denmark Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Germany Orfiril Long 1 000 mg prolonged-release granules Oral Use Denmark Desitin Arzneimittel Gmbh Weg beim Jaeger 214 DE-22335 Hamburg Germany Orfiril Retard 300 mg prolonged-release tablet Oral Use Denmark HEXAL A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark Valproat ‘Hexal’ 300 mg prolonged-release tablet Oral Use Denmark HEXAL A/S Kanalholmen 8-12 DK-2650 Hvidovre Denmark Valproat ‘Hexal’ 500 mg prolonged-release tablet Oral Use Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Valproat ‘Sandoz’ 300 mg prolonged-release tablet Oral Use Denmark Sandoz A/S Edvard Thomsens Vej 14 DK-2300 København S Denmark Valproat ‘Sandoz’ 500 mg prolonged-release tablet Oral Use Denmark Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland Delepsine 300 mg tablet Oral Use Denmark Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland Delepsine 100 mg gastro-resistant tablet Oral Use Denmark Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland Delepsine 300 mg gastro-resistant tablet Oral Use Denmark Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland Delepsine 500 mg gastro-resistant tablet Oral Use Denmark Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland Delepsine 200 mg/ml oral drops, solution Oral Use Denmark Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland Delepsine Retard 300 mg prolonged-release tablet Oral Use Denmark Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland Delepsine Retard 500 mg prolonged-release tablet Oral Use Denmark Orion Corporation Orion Pharma Orionintie 1 FI-02200 Espoo Finland Delepsine 60 mg/ml oral solution Oral Use Estonia Orion Corporation Orion Pharma Orionintie 1 02200 Espoo Finland ABSENOR 500 mg prolonged-release tablet Oral Use Estonia Orion Corporation Orion Pharma Orionintie 1 02200 Espoo Finland ABSENOR 300 mg prolonged-release tablet Oral Use Estonia GEROT PHARMAZEUTIKA GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX 50 mg/ml syrup Oral Use Estonia GEROT PHARMAZEUTIKA GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX 150 MG 150 mg gastro-resistant capsule, soft Oral Use Estonia GEROT PHARMAZEUTIKA GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX 300 MG 300 mg gastro-resistant capsule, soft Oral Use Estonia GEROT PHARMAZEUTIKA GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX 300 MG/ML 300 mg/ml oral drops, solution Oral Use Estonia GEROT PHARMAZEUTIKA GmbH, Arnethgasse 3 A-1160 Wien, Austria CONVULEX 500 MG 500 mg gastro-resistant capsule, soft Oral Use Estonia GEROT PHARMAZEUTIKA GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX RETARD 300 MG 300 mg prolonged-release tablet Oral Use Estonia GEROT PHARMAZEUTIKA GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX RETARD 500 MG 500 mg prolonged-release tablet Oral Use Estonia Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2 11317 Tallinn Estonia DEPAKINE 50 mg/1 ml syrup Oral Use Estonia Sanofi-Aventis Estonia OÜ, Pärnu mnt 139E/2 11317 Tallinn Estonia DEPAKINE CHRONO 300 mg 300 mg prolonged-release tablet Oral Use Estonia Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2 11317 Tallinn Estonia DEPAKINE CHRONO 500 mg 500 mg prolonged-release tablet Oral Use Estonia Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2 11317 Tallinn Estonia DEPAKINE CHRONOSPHERE 500 mg modified-release granules Oral Use Estonia Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2 11317 Tallinn Estonia DEPAKINE CHRONOSPHERE 250 mg modified-release granules Oral Use Estonia Sanofi-Aventis Estonia OÜ Pärnu mnt 139E/2 11317 Tallinn Estonia DEPAKINE CHRONOSPHERE 100 mg modified-release granules Oral Use Estonia Desitin Arzneimittel GmbH Weg beim Jäger 214 D-22335 Hamburg Germany ORFIRIL 150 150 mg gastro-resistant tablet Oral Use Estonia Desitin Arzneimittel GmbH Weg beim Jäger 214 D-22335 Hamburg Germany ORFIRIL 300 300 mg gastro-resistant tablet Oral Use Estonia Desitin Arzneimittel GmbH Weg beim Jäger 214 D-22335 Hamburg Germany ORFIRIL 600 600 mg gastro-resistant tablet Oral Use Estonia Desitin Arzneimittel GmbH Weg beim Jäger 214 D-22335 Hamburg Germany ORFIRIL LONG 1 000 MG 1 000 mg prolonged-release granules Oral Use Estonia Desitin Arzneimittel GmbH Weg beim Jäger 214 D-22335 Hamburg Germany ORFIRIL LONG 150 MG 150 mg prolonged-release capsule, hard Oral Use Estonia Desitin Arzneimittel GmbH Weg beim Jäger 214 D-22335 Hamburg, Germany ORFIRIL LONG 300 MG 300 mg prolonged-release capsule, hard Oral Use Estonia Desitin Arzneimittel GmbH, Weg beim Jäger 214 D-22335 Hamburg Germany ORFIRIL LONG 500 MG 500 mg prolonged-release granules Oral Use Estonia Desitin Arzneimittel GmbH Weg beim Jäger 214 D-22335 Hamburg Germany ORFIRIL SAFT 60 mg/ml oral solution Oral Use Estonia STADA ARZNEIMITTEL AG Stadastr. 2-18 D-61118 Bad Vilbel Germany PRODEPA 500 mg prolonged-release tablet Oral Use Estonia Sandoz d.d., Verovskova 57 1000 Ljubljana Slovenia VALPROATE SODIUM SANDOZ 300 MG 300 mg prolonged-release tablet Oral Use Estonia Sandoz d.d., Verovskova 57 1000 Ljubljana Slovenia VALPROATE SODIUM SANDOZ 500 MG 500 mg prolonged-release tablet Oral Use Finland sanofi-aventis Oy Huopalahdentie 24 B.O. Box 22 FI-00351 Helsinki Finland DEPRAKINE 100 mg/dose prolonged-release granules Oral Use Finland sanofi-aventis Oy Huopalahdentie 24 B.O. Box 22 FI-00351 Helsinki Finland DEPRAKINE 1 000 mg/dose prolonged-release granules Oral Use Finland sanofi-aventis Oy Huopalahdentie 24 B.O. Box 22 FI-00351 Helsinki Finland DEPRAKINE 250 mg/dose prolonged-release granules Oral Use Finland sanofi-aventis Oy Huopalahdentie 24 B.O. Box 22 FI-00351 Helsinki Finland DEPRAKINE 300 mg prolonged-release tablet Oral Use Finland sanofi-aventis Oy Huopalahdentie 24 B.O. Box 22 FI-00351 Helsinki Finland DEPRAKINE 500 mg prolonged-release tablet Oral Use Finland sanofi-aventis Oy Huopalahdentie 24 B.O. Box 22 FI-00351 Helsinki Finland DEPRAKINE 500 mg/dose prolonged-release granules Oral Use Finland sanofi-aventis Oy Huopalahdentie 24 B.O. Box 22 FI-00351 Helsinki Finland DEPRAKINE 100 mg gastro-resistant tablet Oral Use Finland sanofi-aventis Oy Huopalahdentie 24 B.O. Box 22 FI-00351 Helsinki Finland DEPRAKINE 300 mg gastro-resistant tablet Oral Use Finland sanofi-aventis Oy Huopalahdentie 24 B.O. Box 22 FI-00351 Helsinki Finland DEPRAKINE 500 mg gastro-resistant tablet Oral Use Finland sanofi-aventis Oy Huopalahdentie 24 B.O. Box 22 FI-00351 Helsinki Finland DEPRAKINE 60 mg/ml oral solution Oral Use Finland sanofi-aventis Oy Huopalahdentie 24 B.O. Box 22 FI-00351 Helsinki Finland DEPRAKINE 200 mg/ml oral drops, solution Oral Use Finland Orion Oyj Orionintie 1 B.O. Box 65 FI-02201 Espoo Finland ABSENOR 300 mg prolonged-release tablet Oral Use Finland Orion Oyj Orionintie 1 B.O. Box 65 FI-02201 Espoo Finland ABSENOR 500 mg prolonged-release tablet Oral Use Finland Orion Oyj Orionintie 1 B.O. Box 65 FI-02201 Espoo Finland ABSENOR 100 mg gastro-resistant tablet Oral Use Finland Orion Oyj Orionintie 1 B.O. Box 65 FI-02201 Espoo Finland ABSENOR 300 mg gastro-resistant tablet Oral Use Finland Orion Oyj Orionintie 1 B.O. Box 65 FI-02201 Espoo Finland ABSENOR 500 mg gastro-resistant tablet Oral Use Finland Orion Oyj Orionintie 1 B.O. Box 65 FI-02201 Espoo Finland ABSENOR 60 mg/ml oral solution Oral Use Finland Orion Oyj Orionintie 1 B.O. Box 65 FI-02201 Espoo Finland ABSENOR 200 mg/ml oral drops, solution Oral Use Finland Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany NATRIUMVALPRO-AATTI LONG DESITIN 150 mg prolonged-release capsule, hard Oral Use Finland Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany NATRIUMVALPRO-AATTI LONG DESITIN 300 mg prolonged-release capsule, hard Oral Use Finland Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany NATRIUMVALPRO-AATTI LONG DESITIN 1 000 mg/dose prolonged-release granules Oral Use Finland Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany NATRIUMVALPRO-AATTI LONG DESITIN 500 mg/dose prolonged-release granules Oral Use Finland Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany ORFIRIL 60 mg/ml oral solution Oral Use Finland Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany ORFIRIL LONG 150 mg prolonged-release capsule, hard Oral Use Finland Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany ORFIRIL LONG 300 mg prolonged-release capsule, hard Oral Use Finland Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany ORFIRIL LONG 1 000 mg prolonged-release granules Oral Use Finland Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany ORFIRIL LONG 500 mg prolonged-release granules Oral Use Finland Sandoz A/S C.F. Tietgens Boulevard 40, 5220 Odense SØ Denmark VALPROAT SANDOZ 300 mg prolonged-release tablet Oral Use Finland Sandoz A/S C.F. Tietgens Boulevard 40, 5220 Odense SØ Denmark VALPROAT SANDOZ 500 mg prolonged-release tablet Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France DEPAKINE 200 mg gastro-resistant tablet Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France DEPAKINE 500 mg gastro-resistant tablet Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France DEPAKINE 200 mg/ml oral solution Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France DEPAKINE CHRONO 500 mg prolonged-release film-coated tablet Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France DEPAKINE 57,64 mg/ml syrup Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France DEPAMIDE 300 mg gastro-resistant tablet Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France DEPAKOTE 125 mg gastro-resistant tablet Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France DEPAKOTE 250 mg gastro-resistant tablet Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France DEPAKOTE 500 mg gastro-resistant tablet Oral Use France VENIPHARM 4, BUREAUX DE LA COLLINE 92213 SAINT-CLOUD France IMASLAV LP 500 mg prolonged-release film-coated tablet Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France MICROPAKINE LP 100 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France MICROPAKINE LP 1 000 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France MICROPAKINE LP 250 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France MICROPAKINE LP 50 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France MICROPAKINE LP 500 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France MICROPAKINE LP 750 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France MICROPAKINE LP 0,33 g/g prolonged-release granules Oral Use France ALTER 3, avenue de la Baltique 91140 Villebon Sur Yvette France VALPROATE DE SODIUM ALTER L.P. 500 mg prolonged-release film-coated tablet Oral Use France ARROW GENERIQUES 26, avenue Tony Garnier 69007 Lyon France VALPROATE DE SODIUM ARROW L.P. 500 mg prolonged-release film-coated tablet Oral Use France BIOGARAN 15, boulevard Charles de Gaulle 92700 Colombes France VALPROATE DE SODIUM BIOGARAN L.P. 500 mg prolonged-release film-coated tablet Oral Use France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret FRANCE VALPROATE DE SODIUM GNR LP 500 mg prolonged-release film-coated 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 prolonged-release film-coated tablet Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM DAKOTA PHARM, 200 mg gastro-resistant tablet Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM DAKOTA PHARM, 500 mg gastro-resistant tablet Oral Use France MYLAN SAS 117, allée des Parcs 69800 Saint-Priest France VALPROATE DE SODIUM MYLAN L.P. 500 mg prolonged-release film-coated tablet Oral Use France QUALIMED (LYON) 117, allée des Parcs 69800 Saint-Priest France VALPROATE DE SODIUM QUALIMED L.P. 500 mg prolonged-release film-coated tablet Oral Use France RATIOPHARM (ALLEMAGNE) Graf Arco Strasse 3 89079 Ulm Germany VALPROATE DE SODIUM RATIOPHARM L.P. 500 mg prolonged-release film-coated tablet Oral Use France RANBAXY PHARMACIE GENERIQUES 11-15 Quai Dion Bouton 92800 Puteaux France VALPROATE DE SODIUM RPG L.P. 500 mg prolonged-release film-coated tablet Oral Use France SANDOZ 49, avenue Georges Pompidou 92300 Levallois-Perret France VALPROATE DE SODIUM SANDOZ L.P. 500 mg prolonged-release film-coated tablet Oral Use France TEVA CLASSICS Le Palatin 1 92936 Paris la Défense Cedex France VALPROATE DE SODIUM TEVA L.P. 500 mg prolonged-release film-coated tablet Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM WINTHROP 20 % oral solution Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM WINTHROP 200 mg gastro-resistant tablet Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM WINTHROP 500 mg gastro-resistant tablet Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM WINTHROP L.P. 500 mg prolonged-release film-coated tablet Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P. 100 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P. 1 000 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P. 250 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P. 50 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P. 500 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM-ACIDE VALPROIQUE DELALANDE L.P. 750 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P. 100 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P. 1 000 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P. 250 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P. 50 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P. 500 mg prolonged-release granules Oral Use France SANOFI AVENTIS FRANCE 1-13, boulevard Romain Rolland 75014 Paris France VALPROATE DE SODIUM-ACIDE VALPROIQUE SANOFI-SYNTHELABO FRANCE L.P. 750 mg prolonged-release granules Oral Use Germany Lundbeck GmbH Postfach 900662 D-21046 Hamburg Germany CONVULEX 150 150 mg gastro-resistant capsule Oral Use Germany Lundbeck GmbH Postfach 900662 D-21046 Hamburg Germany Convulex 300 300 mg gastro-resistant capsule Oral Use Germany Lundbeck GmbH Postfach 900662 D-21046 Hamburg Germany Convulex 300 mg Retardtabletten 300 mg prolonged-release tablet Oral Use Germany Lundbeck GmbH Postfach 900662 D-21046 Hamburg Germany Convulex 500 500 mg gastro-resistant capsule Oral Use Germany Lundbeck GmbH Postfach 900662 D-21046 Hamburg Germany Convulex 500 mg Retardtabletten 500 mg prolonged-release tablet Oral Use Germany Lundbeck GmbH Postfach 900662 D-21046 Hamburg Germany Convulex Tropflösung 300 mg oral solution Oral Use Germany AWD.pharma GmbH & Co. KG Wasastr. 50 D-01445 Radebeul Germany Convulsofin Tabletten 500 mg tablet Oral Use Germany Steiner & Co. Ostpreussendamm 72-74 D-12207 Berlin Germany Convulsofin-Tropfen 30 g oral drops, solution Oral Use Germany Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 D-65926 Frankfurt am Main Germany Ergenyl 150 mg 150 mg gastro-resistant tablet Oral Use Germany Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 D-65926 Frankfurt am Main Germany Ergenyl 300 mg 300 mg gastro-resistant tablet Oral Use Germany Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 D-65926 Frankfurt am Main Germany Ergenyl 500 mg 500 mg gastro-resistant tablet Oral Use Germany Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 D-65926 Frankfurt am Main Germany Ergenyl chrono 300 mg 300 mg prolonged-release tablet Oral Use Germany Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 D-65926 Frankfurt am Main Germany Ergenyl chrono 500 mg 500 mg prolonged-release tablet Oral Use Germany Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 D-65926 Frankfurt am Main Germany Ergenyl Chronosphere 100 mg Retardgranulat 100 mg prolonged-release granules Oral Use Germany Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 D-65926 Frankfurt am Main Germany Ergenyl Chronosphere 1 000 mg Retardgranulat 1 000,6 mg prolonged-release granules Oral Use Germany Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 D-65926 Frankfurt am Main Germany Ergenyl Chronosphere 250 mg Retardgranulat 250 mg prolonged-release granules Oral Use Germany Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 D-65926 Frankfurt am Main Germany Ergenyl Chronosphere 50 mg Retardgranulat 50 mg prolonged-release granules Oral Use Germany Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 D-65926 Frankfurt am Main Germany Ergenyl Chronosphere 500 mg Retardgranulat 500,3 mg prolonged-release granules Oral Use Germany Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 D-65926 Frankfurt am Main Germany Ergenyl Chronosphere 750 mg Retardgranulat 750 mg prolonged-release granules Oral Use Germany Sanofi-Aventis Deutschland GmbH Industriepark Höchst, Gebäude K703 D-65926 Frankfurt am Main Germany Ergenyl Lösung 300 mg oral solution Oral Use Germany esparma GmbH Seepark 7 D-39116 Magdeburg Germany espa-valept 150 mg 150 mg gastro-resistant tablet Oral Use Germany esparma GmbH Seepark 7 D-39116 Magdeburg Germany espa-valept 300 mg retard 300 mg prolonged-release tablet Oral Use Germany esparma GmbH Seepark 7 D-39116 Magdeburg Germany espa-valept 300 mg 300 mg gastro-resistant tablet Oral Use Germany esparma GmbH Seepark 7 D-39116 Magdeburg Germany espa-valept 500 mg retard 500 mg prolonged-release tablet Oral Use Germany esparma GmbH Seepark 7 D-39116 Magdeburg Germany espa-valept 600 mg 600 mg gastro-resistant tablet Oral Use Germany Dolorgiet GmbH & Co. Postfach 1252 D-53730 St.Augustin Germany Leptilan 150 mg 150 mg gastro-resistant tablet Oral Use Germany Dolorgiet GmbH & Co. Postfach 1252 D-53730 St.Augustin Germany Leptilan 300 mg 300 mg gastro-resistant tablet Oral Use Germany Dolorgiet GmbH & Co. Postfach 1252 D-53730 St.Augustin Germany Leptilan 600 mg 600 mg gastro-resistant tablet Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Natriumvalproat Desitin retard 1 000 mg 1 000 mg prolonged-release tablet Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Natriumvalproat Desitin retard 150 mg 150 mg prolonged-release capsule Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Natriumvalproat Desitin retard 300 mg 300 mg prolonged-release capsule Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Natriumvalproat Desitin retard 500 mg 500 mg prolonged-release tablet Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Orfiril 150 150 mg gastro-resistant tablet Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Orfiril 200 mg 200 mg gastro-resistant tablet Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Orfiril 300 300 mg gastro-resistant tablet Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Orfiril 500 mg 500 mg gastro-resistant tablet Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Orfiril 600 600 mg gastro-resistant tablet Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Orfiril long 1 000 mg 1 000 mg prolonged-release tablet Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Orfiril long 150 mg 150 mg prolonged-release capsule Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Orfiril long 300 mg 300 mg prolonged-release capsule Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Orfiril long 500 mg 500 mg prolonged-release tablet Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Orfiril Saft 60 mg oral solution Oral Use Germany IIP-Institut für industrielle Pharmazie Benzstr. 2 a D-63741 Aschaffenburg Germany Valberg PR 300 mg 300 mg prolonged-release tablet Oral Use Germany IIP-Institut für industrielle Pharmazie Benzstr. 2 a D-63741 Aschaffenburg Germany Valberg PR 500 mg 500 mg prolonged-release tablet Oral Use Germany IIP-Institut für industrielle Pharmazie Benzstr. 2 a D-63741 Aschaffenburg Germany Valdia PR 300 mg 300 mg prolonged-release tablet Oral Use Germany IIP-Institut für industrielle Pharmazie Benzstr. 2 a D-63741 Aschaffenburg Germany Valdia PR 500 mg 500 mg prolonged-release tablet Oral Use Germany IIP-Institut für industrielle Pharmazie Benzstr. 2 a D-63741 Aschaffenburg Germany Valhel PR 300 mg 300 mg prolonged-release tablet Oral Use Germany IIP-Institut für industrielle Pharmazie Benzstr. 2 a D-63741 Aschaffenburg Germany Valhel PR 500 mg 500 mg prolonged-release tablet Oral Use Germany ALIUD PHARMA GmbH Postfach 1380 D-89146 Laichingen Germany Valpro AL 300 mg Retardtabletten 300 mg prolonged-release tablet Oral Use Germany ALIUD PHARMA GmbH Postfach 1380 D-89146 Laichingen Germany Valpro AL 500 mg Retardtabletten 500 mg prolonged-release tablet Oral Use Germany betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany Valpro beta 300 mg oral solution Oral Use Germany betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany Valpro beta 150 150 mg gastro-resistant tablet Oral Use Germany betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany Valpro beta 300 300 mg gastro-resistant tablet Oral Use Germany betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany Valpro beta 600 600 mg gastro-resistant tablet Oral Use Germany betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany Valpro beta chrono 300 mg Retardtabletten 300 mg prolonged-release tablet Oral Use Germany betapharm Arzneimittel GmbH Kobelweg 95 D-86156 Augsburg Germany Valpro beta chrono 500 mg Retardtabletten 500 mg prolonged-release tablet Oral Use Germany TAD Pharma GmbH Postfach 720 D-27457 Cuxhaven Germany Valpro TAD 150 mg 150 mg gastro-resistant tablet Oral Use Germany TAD Pharma GmbH Postfach 720 D-27457 Cuxhaven Germany Valpro TAD 300 mg 300 mg gastro-resistant tablet Oral Use Germany TAD Pharma GmbH Postfach 720 D-27457 Cuxhaven Germany Valpro TAD 600 mg 600 mg gastro-resistant tablet Oral Use Germany TAD Pharma GmbH Postfach 720 D-27457 Cuxhaven Germany Valpro TAD chrono 300 mg 300 mg prolonged-release tablet Oral Use Germany TAD Pharma GmbH Postfach 720 D-27457 Cuxhaven Germany Valpro TAD chrono 500 mg 500 mg prolonged-release tablet Oral Use Germany TAD Pharma GmbH Postfach 720 D-27457 Cuxhaven Germany Valpro TAD Lösung 300 mg oral solution Oral Use Germany AbZ-Pharma GmbH Dr. Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany Valproat AbZ 300 mg Retardtabletten 300 mg prolonged-release tablet Oral Use Germany AbZ-Pharma GmbH Dr. Georg-Spohn-Str. 7 D-89143 Blaubeuren Germany Valproat AbZ 500 mg Retardtabletten 500 mg prolonged-release tablet Oral Use Germany AWD.pharma GmbH & Co. KG Wasastr. 50 D-01445 Radebeul Germany Valproat AWD 300 mg Retardtabletten 300 mg prolonged-release tablet Oral Use Germany AWD.pharma GmbH & Co. KG Wasastr. 50 D-01445 Radebeul Germany Valproat AWD 500 mg Retardtabletten 500 mg prolonged-release tablet Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Valproat chrono Desitin 300 mg Retardtabletten 300 mg prolonged-release tablet Oral Use Germany Desitin Arzneimittel GmbH Postfach 630164 D-22311 Hamburg Germany Valproat chrono Desitin 500 mg Retardtabletten 500 mg prolonged-release tablet Oral Use Germany Winthrop Arzneimittel GmbH Potsdamer Str. 8 10785 Berlin Germany Valproat Chrono Winthrop 300 mg Retardtabletten 300 mg prolonged-release tablet Oral Use Germany Winthrop Arzneimittel GmbH Potsdamer Str. 8 10785 Berlin Germany Valproat Chrono Winthrop 500 mg Retardtabletten 500 mg prolonged-release tablet Oral Use Germany CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Germany Valproat chrono-CT 300 mg Retardtabletten 300 mg prolonged-release tablet Oral Use Germany CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Germany Valproat chrono-CT 500 mg Retardtabletten 500 mg prolonged-release tablet Oral Use Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D-90449 Nürnberg Germany Valproat Heumann chrono 300 mg Retardtabletten 300 mg prolonged-release tablet Oral Use Germany Heumann Pharma GmbH & Co. Generica KG Südwestpark 50 D-90449 Nürnberg Germany Valproat Heumann chrono 500 mg Retardtabletten 500 mg prolonged-release tablet Oral Use Germany HEXAL AG Postfach 1263 D-83602 Holzkirchen Germany Valproat HEXAL 150 mg Filmtabletten 150 mg gastro-resistant tablet Oral Use Germany HEXAL AG Postfach 1263 D-83602 Holzkirchen Germany Valproat HEXAL 300 mg Filmtabletten 300 mg gastro-resistant tablet Oral Use Germany HEXAL AG Postfach 1263 D-83602 Holzkirchen Germany Valproat HEXAL 300 mg/ml Lösung 300 mg oral solution Oral Use Germany HEXAL AG Postfach 1263 D-83602 Holzkirchen Germany Valproat HEXAL 600 mg Filmtabletten 600 mg gastro-resistant tablet Oral Use Germany HEXAL AG Postfach 1263 D-83602 Holzkirchen Germany Valproat HEXAL chrono 300 mg Retardtabletten 300 mg prolonged-release tablet Oral Use Germany HEXAL AG Postfach 1263 D-83602 Holzkirchen Germany Valproat HEXAL chrono 500 mg Retardtabletten 500 mg prolonged-release tablet Oral Use Germany Orion Corporation Postfach P.O. Box 65 FIN-02101 ESPOO Finland Valproat Orion 300 mg Retardtabletten 300 mg prolonged-release tablet Oral Use Germany Orion Corporation Postfach P.O. Box 65 FIN-02101 ESPOO Finland Valproat Orion 500 mg Retardtabletten 500 mg prolonged-release tablet Oral Use Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany Valproat Sandoz 150 mg magensaftresistente Filmtabletten 150 mg gastro-resistant tablet Oral Use Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany Valproat Sandoz 300 mg magensaftresistente Filmtabletten 300 mg gastro-resistant tablet Oral Use Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany Valproat Sandoz 600 mg magensaftresistente Filmtabletten 600 mg gastro-resistant tablet Oral Use Germany Stadapharm GmbH Stadastr. 2-18 D-61118 Bad Vilbel Germany Valproat STADA 300 mg retard 300 mg prolonged-release tablet Oral Use Germany Stadapharm GmbH Stadastr. 2-18 D-61118 Bad Vilbel Germany Valproat STADA 500 mg retard 500 mg prolonged-release tablet Oral Use Germany Winthrop Arzneimittel GmbH Potsdamer Str. 8 10785 Berlin Germany Valproat Win 300 mg Retardtabletten 200 mg prolonged-release tablet Oral Use Germany Winthrop Arzneimittel GmbH Potsdamer Str. 8 10785 Berlin Germany Valproat Win 500 mg Retardtabletten 500 mg prolonged-release tablet Oral Use Germany CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Germany Valproat-CT 150 mg Filmtabletten 150 mg gastro-resistant tablet Oral Use Germany CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Germany Valproat-CT 300 mg Filmtabletten 300 mg gastro-resistant tablet Oral Use Germany CT Arzneimittel GmbH Lengeder Str. 42 a D-13407 Berlin Germany Valproat-CT 600 mg Filmtabletten 600 mg gastro-resistant tablet Oral Use Germany neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany Valproat-neuraxpharm 300 mg oral solution Oral Use Germany neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany Valproat-neuraxpharm 150 150 mg gastro-resistant tablet Oral Use Germany neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany Valproat-neuraxpharm 300 300 mg gastro-resistant tablet Oral Use Germany neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany Valproat-neuraxpharm 600 600 mg gastro-resistant tablet Oral Use Germany neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany Valproat-neuraxpharm chrono 300 mg 300 mg prolonged-release tablet Oral Use Germany neuraxpharm Arzneimittel GmbH u. Co.KG Elisabeth-Selbert-Str. 23 D-40764 Langenfeld Germany Valproat-neuraxpharm chrono 500 mg 500 mg prolonged-release tablet Oral Use Germany Dr. Lach Pharma Consulting Bahnhofstr. 6 D-79359 Riegel Germany Valproat-RPh 150 mg 150 mg gastro-resistant tablet Oral Use Germany Dr. Lach Pharma Consulting Bahnhofstr. 6 D-79359 Riegel Germany Valproat-RPh 300 mg 300 mg gastro-resistant tablet Oral Use Germany Dr. Lach Pharma Consulting Bahnhofstr. 6 D-79359 Riegel Germany Valproat-RPh 600 mg 600 mg gastro-resistant tablet Oral Use Germany Dr. Lach Pharma Consulting Bahnhofstr. 6 D-79359 Riegel Germany Valproat-RPh Lösung 300 mg oral solution Oral Use Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany Valproat-Sandoz 300 mg Retardtabletten 300 mg prolonged-release tablet Oral Use Germany Sandoz Pharmaceuticals GmbH Raiffeisenstr. 11 D-83607 Holzkirchen Germany Valproat-Sandoz 500 mg Retardtabletten 500 mg prolonged-release tablet Oral Use Germany Mylan dura GmbH Postfach 10 06 35 D-64206 Darmstadt Germany valprodura 150 mg 150 mg gastro-resistant tablet Oral Use Germany Mylan dura GmbH Postfach 10 06 35 D-64206 Darmstadt Germany valprodura 300 mg 300 mg gastro-resistant tablet Oral Use Germany Mylan dura GmbH Postfach 10 06 35 D-64206 Darmstadt Germany valprodura 600 mg 600 mg gastro-resistant tablet Oral Use Germany MEDA Pharma GmbH & Co. KG Benzstrasse 1 61352 Bad Homburg Germany Valproinsäure Valeant 300 300 mg gastro-resistant tablet Oral Use Germany MEDA Pharma GmbH & Co. KG Benzstrasse 1 61352 Bad Homburg Germany Valproinsäure Valeant 300 Retard 300 mg prolonged-reclease tablet Oral Use Germany MEDA Pharma GmbH & Co. KG Benzstrasse 1 61352 Bad Homburg Germany Valproinsäure Valeant 500 Retard 500 mg prolonged-release tablet Oral Use Germany MEDA Pharma GmbH & Co. KG Benzstrasse 1 61352 Bad Homburg Germany Valproinsäure Valeant 600 600 mg gastro-resistant tablet Oral Use Germany ratiopharm GmbH D-89070 Ulm Germany Valproinsäure-ratiopharm 150 150 mg gastro-resistant tablet Oral Use Germany ratiopharm GmbH D-89070 Ulm Germany Valproinsäure-ratiopharm 300 Filmtabletten 300 mg gastro-resistant tablet Oral Use Germany ratiopharm GmbH D-89070 Ulm Germany Valproinsäure-ratiopharm 600 600 mg gastro-resistant tablet Oral Use Germany ratiopharm GmbH D-89070 Ulm Germany Valproinsäure-ratiopharm chrono 300 Retardtabletten 300 mg prolonged-release tablet Oral Use Germany ratiopharm GmbH D-89070 Ulm Germany Valproinsäure-ratiopharm chrono 500 Retardtabletten 500 mg prolonged-release tablet Oral Use Germany ratiopharm GmbH D-89070 Ulm Germany Valproinsäure-ratiopharm Lösung 300 mg oral solution Oral Use Germany IIP-Institut für industrielle Pharmazie Benzstr. 2 a D-63741 Aschaffenburg Germany Valsil PR 300 mg 199,8 mg prolonged-release tablet Oral Use Germany IIP-Institut für industrielle Pharmazie Benzstr. 2 a D-63741 Aschaffenburg Germany Valsil PR 500 mg 333 mg prolonged-release tablet Oral Use Greece SANOFI-AVENTIS AEBE 348 Syggrou Avenue, Building A’ Kallithea 17674, Athens Greece DEPAKINE CHRONO 500 MG/TAB prolonged-release tablet Oral Use Greece SANOFI-AVENTIS AEBE 348 Syggrou Avenue, Building A’ Kallithea 17674 Athens Greece DEPAKINE CHRONO 300 MG/TAB prolonged-release tablet Oral Use Greece SANOFI-AVENTIS AEBE 348 Syggrou Avenue, Building A’ Kallithea 17674 Athens Greece DEPAKINE CHRONO (SPHERE) 50 MG/SACHET modified-release granules Oral Use Greece SANOFI-AVENTIS AEBE 348 Syggrou Avenue, Building A’ Kallithea 17674 Athens Greece DEPAKINE CHRONO (SPHERE) 100 MG/SACHET modified-release granules Oral Use Greece SANOFI-AVENTIS AEBE 348 Syggrou Avenue, Building A’ Kallithea 17674 Athens Greece DEPAKINE CHRONO (SPHERE) 250 MG/SACHET modified-release granules Oral Use Greece SANOFI-AVENTIS AEBE 348 Syggrou Avenue, Building A’ Kallithea 17674 Athens Greece DEPAKINE CHRONO (SPHERE) 500 MG/SACHET modified-release granules Oral Use Greece SANOFI-AVENTIS AEBE 348 Syggrou Avenue, Building A’ Kallithea 17674 Athens Greece DEPAKINE CHRONO (SPHERE) 750 MG/SACHET modified-release granules Oral Use Greece SANOFI-AVENTIS AEBE 348 Syggrou Avenue, Building A’ Kallithea 17674 Athens Greece DEPAKINE CHRONO (SPHERE) 1 000 MG/SACHET modified-release granules Oral Use Hungary Orion Corporation Orionintie 1A, FI-02200 Espoo P.O.Box 65, FI-02101 Espoo Finland ABSENOR 300 mg modified-release tablet Oral Use Hungary Orion Corporation Orionintie 1A, FI-02200 Espoo P.O.Box 65, FI-02101 Espoo Finland ABSENOR 500 mg modified-release tablet Oral Use Hungary Gerot Pharmazeutica GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX 150 mg capsule, hard Oral Use Hungary Gerot Pharmazeutica GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX 300 mg capsule, hard Oral Use Hungary Gerot Pharmazeutica GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX 300 mg film-coated tablet Oral Use Hungary Gerot Pharmazeutica GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX 500 mg capsule, hard Oral Use Hungary Gerot Pharmazeutica GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX 500 mg film-coated tablet Oral Use Hungary Gerot Pharmazeutica GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX 43,38 mg/1 ml syrup Oral Use Hungary Sanofi-aventis Tó u. 1-5 HU-1045 Budapest Hungary DEPAKINE CHRONO 300 mg film-coated tablet Oral Use Hungary Sanofi-aventis Tó u. 1-5 HU-1045 Budapest Hungary DEPAKINE CHRONO 500 mg film-coated tablet Oral Use Hungary Sanofi-aventis Tó u. 1-5 HU-1045 Budapest Hungary DEPAKINE CHRONOSPHERE 50 mg (14,51 mg/33,33 mg) modified-release granules Oral Use Hungary Sanofi-aventis Tó u. 1-5 HU-1045 Budapest Hungary DEPAKINE CHRONOSPHERE 100 mg (29,03 mg/66,66 mg) modified-release granules Oral Use Hungary Sanofi-aventis Tó u. 1-5 HU-1045 Budapest Hungary DEPAKINE CHRONOSPHERE 250 mg (72,61 mg/166,76 mg) modified-release granules Oral Use Hungary Sanofi-aventis Tó u. 1-5 HU-1045 Budapest Hungary DEPAKINE 7,50 g/150 ml syrup Oral Use Hungary Desitin Arzneimittel GmbH Weg beim Jäger 214 D-22335, Hamburg Germany ORFIRIL 300 mg gastro-resistant tablet Oral Use Hungary Desitin Arzneimittel GmbH Weg beim Jäger 214 D-22335, Hamburg Germany ORFIRIL 300 mg coated tablet Oral Use Hungary Desitin Arzneimittel GmbH Weg beim Jäger 214 D-22335, Hamburg Germany ORFIRIL 600 mg coated tablet Oral Use Iceland Sanofi-aventis Norge A/S Strandveien 15 1325 Lysaker Norway Depakine 200 mg/ml oral solution Oral Use Iceland Sanofi-aventis Norge A/S Strandveien 15 1325 Lysaker Norway Depakine 200 mg gastro-resistant tablet Oral Use Iceland Sanofi-aventis Norge A/S Strandveien 15 1325 Lysaker Norway Depakine 500 mg gastro-resistant tablet Oral Use Iceland Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany Orfiril 60 mg/ml oral solution Oral Use Iceland Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany Orfiril 150 mg gastro-resistant tablet Oral Use Iceland Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany Orfiril 300 mg gastro-resistant tablet Oral Use Iceland Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany Orfiril 600 mg gastro-resistant tablet Oral Use Iceland Desitin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany Orfiril Retard 300 mg tablet Oral Use Italy Biofutura Pharma S.p.A. Via Pontina Km 30,400 00040 Pomezia - Roma Italy ORFILEPT 300 mg prolonged-release capsule, hard Oral Use Italy Biofutura Pharma S.p.A. Via Pontina Km 30,400 00040 Pomezia - Roma Italy ORFILEPT 500 mg prolonged-release granules Oral Use Italy Biofutura Pharma S.p.A. Via Pontina Km 30,400 00040 Pomezia - Roma Italy ORFILEPT 1 000 mg prolonged-release granules Oral Use Italy Sandoz S.p.A. Largo Boccioni, 1 21040 Origgio (VA) Italy NAVALAC 300 mg prolonged-release tablet Oral Use Italy Sandoz S.p.A. Largo Boccioni, 1 21040 Origgio (VA) Italy NAVALAC 500 mg prolonged-release tablet Oral Use Italy Sandoz S.p.A. Largo Boccioni, 1 21040 Origgio (VA) Italy TOVAPROX 300 mg prolonged-release tablet Oral Use Italy Sandoz S.p.A. Largo Boccioni, 1 21040 Origgio (VA) Italy TOVAPROX 500 mg prolonged-release tablet Oral Use Italy Sandoz S.p.A. Largo Boccioni, 1 21040 Origgio (VA) Italy ACIDO VALPROICO SANDOZ 300 mg prolonged-release tablet Oral Use Italy Sandoz S.p.A. Largo Boccioni, 1 21040 Origgio (VA) Italy ACIDO VALPROICO SANDOZ 500 mg prolonged-release tablet Oral Use Italy Sanofi-Aventis France S.A. 1-13, boulevard Romain Rolland 75014 Paris France DEPAKIN 200 mg gastro-resistant tablet Oral Use Italy Sanofi-Aventis France S.A. 1-13, boulevard Romain Rolland 75014 Paris France DEPAKIN 500 mg gastro-resistant tablet Oral Use Italy Sanofi-Aventis France S.A. 1-13, boulevard Romain Rolland 75014 Paris France DEPAKIN 200 mg/ml oral solution Oral Use Italy Sanofi-Aventis France S.A. 1-13, boulevard Romain Rolland 75014 Paris France DEPAKIN CHRONO 300 mg prolonged-release tablet Oral Use Italy Sanofi-Aventis France S.A. 1-13, boulevard Romain Rolland 75014 Paris France DEPAKIN CHRONO 500 mg prolonged-release tablet Oral use Italy Sanofi-Aventis France S.A. 1-13, boulevard Romain Rolland 75014 Paris France DEPAKIN 1 000 mg modified-release granules Oral Use Italy Sanofi-Aventis France S.A. 1-13, boulevard Romain Rolland 75014 Paris France DEPAKIN 100 mg modified-release granules Oral Use Italy Sanofi-Aventis France S.A. 1-13, boulevard Romain Rolland 75014 Paris France DEPAKIN 250 mg modified-release granules Oral Use Italy Sanofi-Aventis France S.A. 1-13, boulevard Romain Rolland 75014 Paris DEPAKIN 500 mg modified-release granules Oral Use Italy Sanofi-Aventis France S.A. 1-13, boulevard Romain Rolland 75014 Paris France DEPAKIN 50 mg modified-release granules Oral Use Italy Sanofi-Aventis France S.A. 1-13, boulevard Romain Rolland 75014 Paris France DEPAKIN 750 mg modified-release granules Oral Use Italy Sanofi-Aventis spa Viale Luigi/Bodio, 37B 20158 Milano DEPAMIDE 300 mg gastro-resistant tablet Oral Use Italy Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. Viale Shakespeare, 47 00144 Roma Italy DEPAMAG 200 mg gastro-resistant tablet Oral Use Italy Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. Viale Shakespeare, 47 00144 Roma Italy DEPAMAG 500 mg gastro-resistant tablet Oral Use Italy Sigma-Tau Industrie Farmaceutiche Riunite S.p.A. Viale Shakespeare, 47 00144 Roma Italy DEPAMAG 100 mg/ml oral solution Oral Use Italy Ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany ACIDO VALPROICO E SODIO VALPROATO RATIOPHARM 300 mg prolonged-release tablet Oral Use Italy Ratiopharm GmbH Graf-Arco-Str. 3 89079 Ulm Germany ACIDO VALPROICO E SODIO VALPROATO RATIOPHARM 500 mg prolonged-release tablet Oral Use Italy EG Laboratori EuroGenerici S.P.A. Via Pavia, 6 20136 Milano Italy ACIDO VALPROICO E SODIO VALPROATO EG 300 mg prolonged-release tablet Oral Use Italy EG Laboratori EuroGenerici S.P.A. Via Pavia, 6 20136 Milano Italy ACIDO VALPROICO E SODIO VALPROATO EG 500 mg prolonged-release tablet Oral Use Italy Winthrop Pharmaceuticals Italia S.r.l. Viale Luigi Bodio, 37b 20158 Milano Italy SODIO VALPROATO WINTHROP 500 mg gastro-resistant tablet Oral Use Italy Winthrop Pharmaceuticals Italia S.r.l. Viale Luigi Bodio, 37b 20158 Milano Italy SODIO VALPROATO WINTHROP 200 mg/ml oral solution Oral Use Italy Winthrop Pharmaceuticals Italia S.r.l. Viale Luigi Bodio, 37b 20158 Milano Italy SODIO VALPROATO WINTHROP 300 mg prolonged-release tablet Oral Use Italy Winthrop Pharmaceuticals Italia S.r.l. Viale Luigi Bodio, 37b 20158 Milano Italy SODIO VALPROATO WINTHROP 500 mg prolonged-release tablet Oral Use Italy Winthrop Pharmaceuticals Italia S.r.l. Viale Luigi Bodio, 37b 20158 Milano Italy SODIO VALPROATO WINTHROP 200 mg gastro-resistant tablet Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epi-Chrono PA 540/149/1 200 mg prolonged-release tablet Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epi-Chrono PA 540/149/2 300 mg prolonged-release tablet Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epi-Chrono PA 540/149/3 500 mg prolonged-release tablet Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epilim Crushable PA 540/150/1 100 mg tablet Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epilim Enteric PA 540/150/2 200 mg gastro-resistant coated tablet Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epilim Enteric PA 540/150/3 500 mg gastro-resistant coated tablet Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epilim Chronosphere PA 540/150/4 50 mg prolonged-release granules Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epilim Chronosphere PA 540/150/5 100 mg prolonged-release granules Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epilim Chronosphere PA 540/150/6 250 mg prolonged-release granules Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epilim Chronosphere PA 540/150/7 500 mg prolonged-release granules Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epilim Chronosphere PA 540/150/8 750 mg prolonged-release granules Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epilim Chronosphere PA 540/150/9 1 000 mg prolonged-release granules Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epilim Chrono PA 540/150/10 200 mg prolonged-release tablet Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epilim Chrono PA 540/150/11 300 mg prolonged-release tablet Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epilim Chrono PA 540/150/12 500 mg prolonged-release tablet Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epilim Intravenous PA 540/150/13 400 mg powder and solvent for solution for infusion/injection Intravenous Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epilim Liquid PA 540/150/14 200 mg/5 ml oral solution Oral Use Ireland Sanofi-aventis Ireland Limited Citywest Business Campus Dublin 24 Ireland Epilim Syrup PA 540/150/15 200 mg/5 ml syrup Oral Use Latvia Sandoz d.d. Verovškova 57 1000 Ljubljana Slovenia Valproate sodium Sandoz 300 mg prolonged-release tablets 300 mg prolonged-release tablet Oral Use Latvia Sandoz d.d. Verovškova 57 1000 Ljubljana Slovenia Valproate sodium Sandoz 500 mg prolonged-release tablets 500 mg prolonged-release tablet Oral Use Latvia Stada Arzneimittel AG Stadastraße 2-18 D-61118 Bad Vilbel Germany Convulex 150 mg gastro-resistant capsules, soft 150 mg gastro-resistant capsule, soft Oral Use Latvia Gerot Pharmazeutika Ges.m.b.H Arnethgasse 3 AT-1160 Wien AUSTRIA Convulex 300 mg gastro-resistant capsules, soft 300 mg gastro-resistant capsule, soft Oral Use Latvia Gerot Pharmazeutika Ges.m.b.H Arnethgasse 3 AT-1160 Wien AUSTRIA Convulex 500 mg gastro-resistant capsules, soft 500 mg gastro-resistant capsule, soft Oral Use Latvia Gerot Pharmazeutika Ges.m.b.H Arnethgasse 3 AT-1160 Wien AUSTRIA Convulex 500 mg gastro-resistant capsules, soft 500 mg gastro-resistant capsule, soft Oral Use Latvia Gerot Pharmazeutika Ges.m.b.H Arnethgasse 3 AT-1160 Wien AUSTRIA Convulex retard 300 mg prolonged release tablets 300 mg prolonged-release tablet Oral Use Latvia Gerot Pharmazeutika Ges.m.b.H Arnethgasse 3 AT-1160 Wien AUSTRIA Convulex retard 500 mg prolonged release tablets 500 mg prolonged-release tablet Oral Use Latvia Gerot Pharmazeutika Ges.m.b.H Arnethgasse 3 AT-1160 Wien AUSTRIA Convulex 50 mg/ml syrup 50 mg/ml syrup Oral Use Latvia Gerot Pharmazeutika Ges.m.b.H Arnethgasse 3 AT-1160 Wien AUSTRIA Convulex 300 mg/ml oral solution 300 mg/ml oral solution Oral Use Latvia Sanofi-aventis Latvia SIA Kr. Valdemāra iela 33 - 8 LV - 1010 Riga Latvia Depakine Chrono 300 mg prolonged release tablets 300 mg prolonged-release tablet Oral Use Latvia Sanofi-aventis Latvia SIA Kr. Valdemāra iela 33 - 8 LV - 1010 Riga Latvia Depakine Chrono 500 mg prolonged release tablets 500 mg prolonged-release tablet Oral Use Latvia Sanofi-aventis Latvia SIA Kr. Valdemāra iela 33 - 8 LV - 1010 Riga Latvia Depakine 57,64 mg/ml syrup 57,64 mg/ml syrup Oral Use Latvia Orion Corporation Orionintie 1 FI - 02200 Espoo FINLAND Absenor 500 mg prolonged release tablets 500 mg prolonged-release tablet Oral Use Latvia Orion Corporation Orionintie 1 FI - 02200 Espoo FINLAND Absenor 300 mg prolonged release tablets 300 mg prolonged-release tablet Oral Use Lithuania Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 A-1160 Vienna Austria Convulex retard 500 mg prolonged-release tablet Oral Use Lithuania Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 A-1160 Vienna Austria Convulex retard 300 mg prolonged-release tablet Oral Use Lithuania Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 A-1160 Vienna Austria Convulex 50 mg/ml syrup Oral Use Lithuania Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 A-1160 Vienna Austria Convulex 300 mg/ml oral solution Oral Use Lithuania Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 A-1160 Vienna Austria Convulex 150 mg gastro-resistant capsule, soft Oral Use Lithuania Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 A-1160 Vienna Austria Convulex 300 mg gastro-resistant capsule, soft Oral Use Lithuania Gerot Pharmazeutika Ges. m. b. H. Arnethgasse 3 A-1160 Vienna Austria Convulex 500 mg gastro-resistant capsule, soft Oral Use Lithuania Orion Corporation Orionintie 1 FI-02200 Espoo Finland Absenor 500 mg prolonged-release tablet Oral Use Lithuania Orion Corporation Orionintie 1 FI-02200 Espoo Finland Absenor 300 mg prolonged-release tablet Oral Use Lithuania UAB „Sanofi Aventis“ Lietuva A. Juozapaviciaus 6/2 LT-09310 Vilnius Lithuania Depakine 57,64 mg/ml syrup Oral Use Lithuania UAB „Sanofi Aventis“ Lietuva A. Juozapaviciaus 6/2 LT-09310 Vilnius Lithuania Depakine Chronosphere 50 mg modified-release granules Oral Use Lithuania UAB „Sanofi Aventis“ Lietuva A. Juozapaviciaus 6/2 LT-09310 Vilnius Lithuania Depakine Chronosphere 100 mg modified-release granules Oral Use Lithuania UAB „Sanofi Aventis“ Lietuva A. Juozapaviciaus 6/2 LT-09310 Vilnius Lithuania Depakine Chronosphere 250 mg modified-release granules Oral Use Lithuania UAB „Sanofi Aventis“ Lietuva A. Juozapaviciaus 6/2 LT-09310 Vilnius Lithuania Depakine Chronosphere 500 mg modified-release granules Oral Use Lithuania UAB „Sanofi Aventis“ Lietuva A. Juozapaviciaus 6/2 LT-09310 Vilnius Lithuania Depakine Chronosphere 750 mg modified-release granules Oral Use Lithuania UAB „Sanofi Aventis“ Lietuva A. Juozapaviciaus 6/2 LT-09310 Vilnius Lithuania Depakine Chronosphere 1 000 mg modified-release granules Oral Use Lithuania UAB „Sanofi Aventis“ Lietuva A. Juozapaviciaus 6/2 LT-09310 Vilnius Lithuania Depakine Chrono 500 mg modified-release tablet Oral Use Lithuania UAB „Sanofi Aventis“ Lietuva A. Juozapaviciaus 6/2 LT-09310 Vilnius Lithuania Depakine Chronosphere 300 mg modified-release tablet Oral Use Lithuania Stada Arzneimittel AG Stadastrasse 2-18 61118 Bad Vilbel Germany Prodepa 500 mg prolonged-release tablet Oral Use Lithuania Sandoz d.d. Verovskova 57 1000 Ljubljana Slovenia Valproate sodium Sandoz 300 mg prolonged-release tablet Oral Use Lithuania Sandoz d.d. Verovskova 57 1000 Ljubljana Slovenia Valproate sodium Sandoz 500 mg prolonged-release tablet Oral Use Luxembourg Sanofi-Aventis Belgium Culliganlaan 1C B-1831 Diegem Belgium DEPAKINE 30 % solution Oral Use Luxembourg Sanofi-Aventis Belgium Culliganlaan 1C B-1831 Diegem Belgium DEPAKINE 6 % syrup Oral Use Luxembourg Sanofi-Aventis Belgium Culliganlaan 1C B-1831 Diegem Belgium DEPAKINE CHRONO 300 mg tablet Oral Use Luxembourg Sanofi-Aventis Belgium Culliganlaan 1C B-1831 Diegem Belgium DEPAKINE CHRONO 500 mg tablet Oral Use Luxembourg Sanofi-Aventis Belgium Culliganlaan 1C B-1831 Diegem Belgium DEPAKINE ENTERIC 150 mg tablet Oral Use Luxembourg Sanofi-Aventis Belgium Culliganlaan 1C B-1831 Diegem Belgium DEPAKINE ENTERIC 300 mg tablet Oral Use Luxembourg Sanofi-Aventis Belgium Culliganlaan 1C B-1831 Diegem Belgium DEPAKINE ENTERIC 500 mg tablet Oral Use Luxembourg Gerot Pharmazeutika GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX 300 mg prolonged-release tablet Oral Use Luxembourg Gerot Pharmazeutika GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX 500 mg prolonged-release tablet Oral Use Luxembourg Gerot Pharmazeutika GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX 250 mg/5 ml syrup Oral Use Luxembourg Gerot Pharmazeutika GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX 300 mg capsule Oral Use Luxembourg Gerot Pharmazeutika GmbH Arnethgasse 3 A-1160 Wien Austria CONVULEX 500 mg capsule Oral Use Luxembourg Ratiopharm GmbH Arzneimittel Postfach 3380 D-89070 Ulm Germany Valproinsäure-Ratiopharm 300 mg prolonged-release tablet Oral Use Luxembourg Ratiopharm GmbH Arzneimittel Postfach 3380 D-89070 Ulm Germany Valproinsäure-Ratiopharm 500 mg prolonged-release tablet Oral Use Luxembourg Hexal AG Industriestrasse 25 D-83607 Holzkirchen Germany Valproat-Hexal Chrono 300 mg tablet Oral Use Luxembourg Hexal AG Industriestrasse 25 D-83607 Holzkirchen Germany Valproat-Hexal Chrono 500 mg tablet Oral Use Luxembourg Eurogenerics s.a. Esplanade Heysel B.22 B-1020 Bruxelles Belgium Valproate Retard-EG 300 mg prolonged-release tablet Oral Use Luxembourg Eurogenerics s.a. Esplanade Heysel B.22 B-1020 Bruxelles Belgium Valproate Retard-EG 500 mg prolonged-release tablet Oral Use Malta Norton Healthcare Limited Ivax Pharmaceuticals Ivax Quays Albert Basin, Royal Docks London E16 2QJ United Kingdom Sodium valproate oral solution BP 200 mg/5 ml oral solution Oral Use Malta Sanofi-Aventis Malta Limited Triq Kanonku K. Pirotta Birkirkara BKR 1114 Malta Epilim liquid 200 mg/5 ml oral liquid Oral Use Malta Sanofi-Aventis Malta Limited Triq Kanonku K. Pirotta Birkirkara BKR 1114 Malta Epilim Chrono 200 Controlled Release 200 mg prolonged-release tablet Oral Use Malta Sanofi-Aventis Malta Limited Triq Kanonku K. Pirotta Birkirkara BKR 1114 Malta Epilim Chrono 300 Controlled release 300 mg prolonged-release tablet Oral Use Malta Sanofi-Aventis Malta Limited Triq Kanonku K. Pirotta Birkirkara BKR 1114 Malta Epilim Chrono 500 Controlled release 500 mg prolonged-release tablet Oral Use Malta Sanofi-Aventis Malta Limited Triq Kanonku K. Pirotta Birkirkara BKR 1114 Malta Epilim Chronosphere MR 50 mg 50 mg modified-release granules Oral Use Malta Sanofi-Aventis Malta Limited Triq Kanonku K. Pirotta Birkirkara BKR 1114 Malta Epilim Chronosphere MR 100 mg 100 mg modified-release granules Oral Use Malta Sanofi-Aventis Malta Limited Triq Kanonku K. Pirotta Birkirkara BKR 1114 Epilim Chronosphere MR 250 mg 250 mg modified-release granules Oral Use Malta Sanofi-Aventis Malta Limited Triq Kanonku K. Pirotta Birkirkara BKR 1114 Malta Epilim Chronosphere MR 500 mg 500 mg modified-release granules Oral Use Malta Sanofi-Aventis Malta Limited Triq Kanonku K. Pirotta Birkirkara BKR 1114 Malta Epilim Chronosphere MR 750 mg 750 mg modified-release granules Oral Use Malta Sanofi-Aventis Malta Limited Triq Kanonku K. Pirotta Birkirkara BKR 1114 Malta Epilim Chronosphere MR 1 000 mg 1 000 mg modified-release granules Oral Use Norway Destin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany Orfiril Long 500 mg prolonged-release granules Oral Use Norway Destin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany Orfiril Long 1 000 mg prolonged-release granules Oral Use Norway Destin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany Orfiril Long 150 mg prolonged-release capsule Oral Use Norway Destin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany Orfiril Long 300 mg prolonged-release capsule Oral Use Norway Destin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany Orfiril Retard 300 mg prolonged-release tablet Oral Use Norway Destin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany Orfiril 150 mg gastro-resistant tablet Oral Use Norway Destin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany Orfiril 300 mg gastro-resistant tablet Oral Use Norway Destin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany Orfiril 600 mg gastro-resistant tablet Oral Use Norway Sanofi-Aventis Norge AS PB 133 1325 Lysaker Norway Deprakine 100 mg gastro-resistant tablet Oral Use Norway Sanofi-Aventis Norge AS PB 133 1325 Lysaker Norway Deprakine 300 mg gastro-resistant tablet Oral Use Norway Sanofi-Aventis Norge AS PB 133 1325 Lysaker Norway Deprakine 500 mg gastro-resistant tablet Oral Use Norway Destin Arzneimittel GmbH Weg beim Jäger 214 22335 Hamburg Germany Orfiril 60 mg/mL oral solution Oral Use Norway Sanofi-Aventis Norge AS PB 133 1325 Lysaker Norway Deprakine 60 mg/mL oral solution Oral Use Poland G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach Austria Convulex 150 150 mg capsule, soft Oral Use Poland G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach Austria Convulex 300 300 mg capsule, soft Oral Use Poland G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach Austria Convulex 500 mg capsule, soft Oral Use Poland G.L. Pharma GmbH Schloβplatz 1 A-8502 Lannach Austria Convulex 50 mg/ml syrup Oral Use Poland Desitin Arznemittel GmbH Weg beim Jager 214 Hamburg 22335 Germany Orfiril 300 mg/5 ml (60 mg/ml) oral solution Oral Use Poland Desitin Arznemittel GmbH Weg beim Jager 214 Hamburg 22335 Germany Orfiril 150 150 mg gastro-resistant tablet Oral Use Poland Desitin Arznemittel GmbH Weg beim Jager 214 Hamburg 22335 Germany Orfiril 300 300 mg gastro-resistant tablet Oral Use Poland Desitin Arznemittel GmbH Weg beim Jager 214 Hamburg 22335 Germany Orfiril 600 600 mg gastro-resistant tablet Oral Use Poland Desitin Arznemittel GmbH Weg beim Jager 214 Hamburg 22335 Germany Orfiril 300 retard 300 mg prolonged-release gastro-resistant tablet Oral Use Poland Desitin Arznemittel GmbH Weg beim Jager 214 Hamburg 22335 Germany Orfiril Long 150 150 mg prolonged-release capsule Oral Use Poland Desitin Arznemittel GmbH Weg beim Jager 214 Hamburg 22335 Germany Orfiril Long 300 300 mg prolonged-release capsule Oral Use Poland Desitin Arznemittel GmbH Weg beim Jager 214 Hamburg 22335 Germany Orfiril Long 500 500 mg prolonged-release mini-tablet Oral Use Poland Desitin Arznemittel GmbH Weg beim Jager 214 Hamburg 22335 Germany Orfiril Long 1 000 1 000 mg prolonged-release mini-tablet Oral Use Poland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm 89079 Germany Valproic Acid ER-APC 300 300 mg prolonged-release tablet Oral Use Poland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm89079 Germany Valproic Acid ER-APC 500 500 mg prolonged-release tablet Oral Use Poland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm 89079 Germany Valpro-ratiopharm Chrono 300 mg 199,8 mg + 87 mg prolonged-release tablet Oral Use Poland ratiopharm GmbH Graf-Arco-Strasse 3 Ulm 89079 Germany Valpro-ratiopharm Chrono 500 mg 333 mg + 145 mg prolonged-release tablet Oral Use Poland Sanofi-Aventis Sp. z o.o. ul. Bonifraterska 17 Warsaw 00-203 Poland Depakine Chrono 300 200 mg + 87 mg prolonged-release film-coated tablet Oral Use Poland Sanofi-Aventis Sp. z o.o. ul. Bonifraterska 17 00.-203 Warsaw Poland Depakine Chrono 500 333 mg + 145 mg prolonged-release film-coated tablet Oral Use Poland Sanofi-Aventis Sp. z o.o. ul. Bonifraterska 17 00.-203 Warsaw Poland Depakine Chronosphere 100 66,66 mg + 29,03 mg prolonged-release granules Oral Use Poland Sanofi-Aventis Sp. z o.o. ul. Bonifraterska 17 00.-203 Warsaw Poland Depakine Chronosphere 250 166,76 mg + 72,61 mg prolonged-release granules Oral Use Poland Sanofi-Aventis Sp. z o.o. ul. Bonifraterska 17 00.-203 Warsaw Poland Depakine Chronosphere 500 333,30 mg + 145,14 mg prolonged-release granules Oral Use Poland Sanofi-Aventis Sp. z o.o. ul. Bonifraterska 17 00.-203 Warsaw Poland Depakine Chronosphere 750 500,06 mg + 217,75 mg prolonged-release granules Oral Use Poland Sanofi-Aventis Sp. z o.o. ul. Bonifraterska 17 00.-203 Warsaw Poland Depakine Chronosphere 1 000 666,60 mg + 290,27 mg prolonged-release granules Oral Use Poland Sanofi-Aventis France 1-13 bld Romain Rolland 75014 Paris France Depakine 288,2 mg/5 ml syrup Oral Use Poland Sanofi-Aventis France 1-13 bld Romain Rolland 75014 Paris France Depakine 200 200 mg film-coated tablet Oral Use Poland ICN Polfa Rzeszów S.A. Przemysłowa 2 st. Rzeszów 35-959 Poland Dipromal 200 mg film-coated tablet Oral Use Poland Sandoz GmbH Biochemiestrasse 10 Kundl 6250 Austria ValproLEK 300 300 mg prolonged-release tablet Oral Use Poland Sandoz GmbH Biochemiestrasse 10 Kundl 6250 Austria ValproLEK 500 500 mg prolonged-release tablet Oral Use Poland Orion Corporation Orionintie 1 Espoo 02200 Finland Absenor 300 mg modified-release tablet Oral Use Poland Orion Corporation Orionintie 1 Espoo 02200 Finland Absenor 500 mg modified-release tablet Oral Use Portugal Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park Edifício 7 - 3o 2740-299 Porto Salvo Portugal Depakine 200 mg/ml oral solution Oral Use Portugal Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park Edifício 7 - 3o 2740-299 Porto Salvo Portugal Depakine Chrono 300 300 mg prolonged-release tablet Oral Use Portugal Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park Edifício 7 - 3o 2740-299 Porto Salvo Portugal Depakine Chrono 500 500 mg prolonged-release tablet Oral Use Portugal Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan - Amoreiras - Torre 3 - 12o 1099-036 Lisboa Portugal Diplexil 200 mg coated tablet Oral Use Portugal Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan - Amoreiras - Torre 3 - 12o 1099-036 Lisboa Portugal Diplexil 500 mg gastro-resistant tablet Oral Use Portugal Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan - Amoreiras - Torre 3 - 12o 1099-036 Lisboa Portugal Diplexil 200 mg/ml oral solution Oral Use Portugal Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan - Amoreiras - Torre 3 - 12o 1099-036 Lisboa Portugal Diplexil-R 250 mg coated tablet Oral Use Portugal Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan - Amoreiras - Torre 3 - 12o 1099-036 Lisboa Portugal Diplexil-R 500 mg coated tablet Oral Use Portugal Sanofi-Aventis - Produtos Farmacêuticos, S.A. Empreendimento Lagoas Park, Edifício 7 - 3o 2740-299 Porto Salvo Portugal Depakine 40 mg/ml syrup Oral Use Portugal Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan - Amoreiras - Torre 3 - 12o 1099-036 Lisboa Portugal Diplexil 150 150 mg prolonged-release capsule Oral Use Portugal Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan - Amoreiras - Torre 3 - 12o 1099-036 Lisboa Portugal Diplexil 300 300 mg prolonged-release capsule Oral Use Portugal Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan - Amoreiras - Torre 3 - 12o 1099-036 Lisboa Portugal Diplexil 500 500 mg prolonged-release granules Oral Use Portugal Tecnifar - Indústria Técnica Farmacêutica, S.A. Rua Tierno Galvan - Amor