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 or Article 38 of Directive 2001/82/EC )
Date: 2010-10-29
Institutions: European Commission
Subjects: European Medicines Agency, drug surveillance, market approval, marketing, medicinal product, pharmaceutical industry, veterinary drug








C_2010295EN.01001701.xml










29.10.2010   


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 - Amoreiras - Torre 3 - 12o





1099-036 Lisboa




Portugal






Diplexil 1 000


1 000 mg


prolonged-release granules


Oral Use




Portugal







Sanofi-Aventis - Produtos Farmacêuticos, S.A.




Empreendimento Lagoas Park, Edifício 7 - 3o





2740-299 Porto Salvo




Portugal






Depakine Chronosphere 50/350


50 - 350 mg


modified-release granules


Oral Use




Portugal







Sanofi-Aventis - Produtos Farmacêuticos, S.A.




Empreendimento Lagoas Park, Edifício 7 - 3o





2740-299 Porto Salvo




Portugal






Depakine Chronosphere 500/1 000


500 - 1 000 mg


modified-release granules


Oral Use




Portugal







Sanofi-Aventis - Produtos Farmacêuticos, S.A.




Empreendimento Lagoas Park, Edifício 7 - 3o





2740-299 Porto Salvo




Portugal






Depakine Chronosphere 50 mg


50 mg


modified-release granules


Oral Use




Portugal







Sanofi-Aventis - Produtos Farmacêuticos, S.A.




Empreendimento Lagoas Park, Edifício 7 - 3o





2740-299 Porto Salvo




Portugal






Depakine Chronosphere 100 mg


100 mg


modified-release granules


Oral Use




Portugal







Sanofi-Aventis - Produtos Farmacêuticos, S.A.




Empreendimento Lagoas Park, Edifício 7 - 3o





2740-299 Porto Salvo




Portugal






Depakine Chronosphere 250 mg


250 mg


modified-release granules


Oral Use




Portugal







Sanofi-Aventis - Produtos Farmacêuticos, S.A.




Empreendimento Lagoas Park, Edifício 7 - 3o





2740-299 Porto Salvo




Portugal






Depakine Chronosphere 500 mg


500 mg


modified-release granules


Oral Use




Portugal







Sanofi-Aventis - Produtos Farmacêuticos, S.A.




Empreendimento Lagoas Park, Edifício 7 - 3o





2740-299 Porto Salvo




Portugal






Depakine Chronosphere 750 mg


750 mg


modified-release granules


Oral Use




Portugal







Sanofi-Aventis - Produtos Farmacêuticos, S.A.




Empreendimento Lagoas Park, Edifício 7 - 3o





2740-299 Porto Salvo




Portugal






Depakine Chronosphere 1 000 mg


1 000 mg


modified-release granules


Oral Use




Portugal







Sandoz Farmacêutica, Lda.




Alameda da Beloura, Edifício 1, 2o - Escritório 15




2710-693 Sintra




Portugal






Ácido Valpróico Sandoz 300 mg Comprimidos de libertação prolongada


300 mg


prolonged-release tablet


Oral Use




Portugal







Generis Farmacêutica, S.A.




Office Park da Beloura, Edifício 4, Quinta da Beloura




2710-444 Sintra




Portugal






Ácido Valpróico Generis


500 mg


prolonged-release tablet


Oral Use




Portugal







Generis Farmacêutica, S.A.




Office Park da Beloura, Edifício 4, Quinta da Beloura




2710-444 Sintra




Portugal






Ácido Valpróico Generis


300 mg


prolonged-release tablet


Oral Use




Portugal







Sandoz Farmacêutica, Lda.




Alameda da Beloura, Edifício 1, 2o - Escritório 15




2710-693 Sintra




Portugal






Ácido Valpróico Sandoz 500 mg Comprimidos de libertação prolongada


500 mg


prolonged-release tablet


Oral Use




Portugal







Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.




Rua Quinta do Pinheiro




Edifício Tejo - 6o Piso




2790-143 Carnaxide




Portugal






Ácido Valpróico Ratiopharm 300 mg Comprimidos de libertação prolongada


300 mg


prolonged-release tablet


Oral Use




Portugal







Ratiopharm - Comércio e Indústria de Produtos Farmacêuticos, Lda.




Rua Quinta do Pinheiro




Edifício Tejo - 6o Piso




2790-143 Carnaxide




Portugal






Ácido Valpróico Ratiopharm 500 mg Comprimidos de libertação prolongada


500 mg


prolonged-release tablet


Oral Use




Romania







SANOFI AVENTIS FRANCE




1-13 boulevard Romain Rolland




75014 Paris




France






DEPAKINE CHRONOSPHERE 100 mg


29,03 mg/66,66 mg


prolonged-release granules


Oral Use




Romania







SANOFI AVENTIS FRANCE




1-13 boulevard Romain Rolland




75014 Paris




France






DEPAKINE CHRONOSPHERE 250 mg


72,61 mg/166,76 mg


prolonged-release granules


Oral Use




Romania







SANOFI AVENTIS FRANCE




1-13 boulevard Romain Rolland




75014 Paris




France






DEPAKINE CHRONOSPHERE 500 mg


145,14 mg/333,3 mg


prolonged-release granules


Oral Use




Romania







SANOFI AVENTIS FRANCE




1-13 boulevard Romain Rolland




75014 Paris




France






DEPAKINE CHRONOSPHERE 750 mg


217,75 mg/500,06 mg


prolonged-release granules


Oral Use




Romania







SANOFI AVENTIS FRANCE




1-13 boulevard Romain Rolland




75014 Paris




France






DEPAKINE CHRONOSPHERE 1 000 mg


290,27 mg/666,60 mg


prolonged-release granules


Oral Use




Romania







SANOFI AVENTIS FRANCE




1-13 boulevard Romain Rolland




75014 Paris




France






DEPAKINE


57,64 mg/ml


syrup


Oral Use




Romania







SANOFI AVENTIS FRANCE




1-13 boulevard Romain Rolland




75014 Paris




France






DEPAKINE CHRONO 300 mg


87 mg/199,8 mg


prolonged – release tablet


Oral Use




Romania







SANOFI AVENTIS FRANCE




1-13 boulevard Romain Rolland




75014 Paris




France






DEPAKINE CHRONO 500 mg


145 mg/333 mg


prolonged – release tablet


Oral Use




Romania







SANOFI AVENTIS FRANCE




1-13 boulevard Romain Rolland




75014 Paris




France






DEPAKINE 200 mg


200 mg


gastro – resistant tablet


Oral Use




Romania







DESITIN ARZNEIMITTEL GmbH




Weg Beim Jäger 214




22335 Hamburg




Germany






ORFIRIL 150


150 mg


gastro - resistant tablet


Oral Use




Romania







DESITIN ARZNEIMITTEL GmbH




Weg Beim Jäger 214




22335 Hamburg




Germany






ORFIRIL 300


300 mg


gastro - resistant tablet


Oral Use




Romania







DESITIN ARZNEIMITTEL GmbH




Weg Beim Jäger 214




22335 Hamburg




Germany






ORFIRIL 600


600 mg


gastro - resistant tablet


Oral Use




Romania







DESITIN ARZNEIMITTEL GmbH




Weg Beim Jäger 214




22335 Hamburg




Germany






ORFIRIL LONG 150 mg


150 mg


prolonged-release capsule


Oral Use




Romania







DESITIN ARZNEIMITTEL GmbH




Weg Beim Jäger 214




22335 Hamburg




Germany






ORFIRIL LONG 300 mg


300 mg


prolonged-release capsule


Oral Use




Romania







DESITIN ARZNEIMITTEL GmbH




Weg Beim Jäger 214




22335 Hamburg




Germany






ORFIRIL LONG 500 mg


500 mg


prolonged-release granules


Oral Use




Romania







DESITIN ARZNEIMITTEL GmbH




Weg Beim Jäger 214




22335 Hamburg




Germany






ORFIRIL LONG 1 000 mg


1 000 mg


prolonged-release granules


Oral Use




Romania







DESITIN ARZNEIMITTEL GmbH




Weg Beim Jäger 214




22335 Hamburg




Germany






ORFIRIL SIROP


300 mg/5 ml


syrup


Oral Use




Romania







GEROT PHARMAZEUTIKA Ges.m.b.H.




Arnethgasse 3




A-1160 Wien




Austria






CONVULEX 150 mg


150 mg


gastro-resistant capsule, soft


Oral Use




Romania







GEROT PHARMAZEUTIKA Ges.m.b.H.




Arnethgasse 3




A-1160 Wien




Austria






CONVULEX 300 mg


300 mg


gastro-resistant capsule, soft


Oral Use




Romania







GEROT PHARMAZEUTIKA Ges.m.b.H.




Arnethgasse 3




A-1160 Wien




Austria






CONVULEX 500 mg


500 mg


gastro-resistant capsule, soft


Oral Use




Romania







GEROT PHARMAZEUTIKA Ges.m.b.H.




Arnethgasse 3




A-1160 Wien




Austria






CONVULEX RETARD 300 mg


300 mg


prolonged-release tablet


Oral Use




Romania







GEROT PHARMAZEUTIKA Ges.m.b.H.




Arnethgasse 3




A-1160 Wien




Austria






CONVULEX RETARD 500 mg


500 mg


prolonged-release tablet


Oral Use




Romania







GEROT PHARMAZEUTIKA Ges.m.b.H.




Arnethgasse 3




A-1160 Wien




Austria






CONVULEX 50 mg/ml


50 mg/ml


syrup


Oral Use




Romania







REMEDICA Ltd.




Limassol Industrial Estate




Aharnon P.O Box 51706




3508 Limassol




Cyprus






PETILIN 200


200 mg


film-coated tablet


Oral Use




Romania







S.C. ARENA GROUP S.A.




Str. Ștefan Mihăileanu nr. 31




Sector 2, București




România






VALEPIL


200 mg/5 ml


syrup


Oral Use




The Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Propymal Enteric 150 mg


150 mg


gastro-resistant capsule, soft


Oral Use




The Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Propymal Enteric 300 mg


300 mg


gastro-resistant capsule, soft


Oral Use




The Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Propymal Enteric 450 mg


450 mg


gastro-resistant capsule, soft


Oral Use




The Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Propymal Enteric 600 mg


600 mg


gastro-resistant capsule, soft


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Zuur


125 mg


gastro-resistant capsule, soft


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Zuur


250 mg


gastro-resistant capsule, soft


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Zuur


500 mg


gastro-resistant capsule, soft


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine


300 mg


tablet


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine


300 mg/ml


oral drops, solution


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Retard


300 mg


modified-release tablet


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Enteric


150 mg


gastro-resistant tablet


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Enteric


300 mg


gastro-resistant tablet


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Enteric


500 mg


gastro-resistant tablet


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine vloeistof voor kinderen


300 mg/ml


oral solution


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine suikervrije stroop


40 mg/ml


syrup


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Natriumvalproaat Enteric Winthrop 150 mg


150 mg


gastro-resistant tablet


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Natriumvalproaat Enteric Winthrop 300 mg


300 mg


gastro-resistant tablet


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Natriumvalproaat Enteric Winthrop 500 mg


500 mg


gastro-resistant tablet


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Natrii Valproas


300 mg


gastro-resistant tablet


Oral Use




The Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Natriumvalproaat Apotex 150 mg


150 mg


gastro-resistant tablet


Oral Use




The Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Natriumvalproaat Apotex 300 mg


300 mg


gastro-resistant tablet


Oral Use




The Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Natriumvalproaat Apotex 600 mg


600 mg


gastro-resistant tablet


Oral Use




The Netherlands







Apotex Europe B.V.




Darwinweg 20




2333 CR Leiden




The Netherlands






Natriumvalproaat Apotex 300 mg/5 ml


60 mg/ml


oral solution


Oral Use




The Netherlands







Pharmachemie BV




Swensweg 5




NL-2003 RN Haarlem




The Netherlands






Orfiril CR 150 mg


150 mg


modified-release capsule


Oral Use




The Netherlands







Pharmachemie BV




Swensweg 5




NL-2003 RN Haarlem




The Netherlands






Orfiril CR 300 mg


300 mg


modified-release capsule


Oral Use




The Netherlands







Pharmachemie BV




Swensweg 5




NL-2003 RN Haarlem




The Netherlands






Orfiril CR 500 mg


500 mg


modified-release granules


Oral Use




The Netherlands







Pharmachemie BV




Swensweg 5




NL-2003 RN Haarlem




The Netherlands






Orfiril CR 1 000 mg


1 000 mg


modified-release granules


Oral Use




The Netherlands







Ratiopharm Nederland B.V.




Ronde Tocht 11




NL-1507 CC Zaandam




The Netherlands






Natriumvalproaat ratiopharm chrono 300 mg


300 mg


modified-release tablet


Oral Use




The Netherlands







Ratiopharm Nederland B.V.




Ronde Tocht 11




NL-1507 CC Zaandam




The Netherlands






Natriumvalproaat ratiopharm chrono 500 mg


500 mg


modified-release tablet


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Chrono 300


200 mg sodium valproate and 87 mg valproic acid


modified-release tablet


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Chrono 500


333 mg sodium valproate and 145 mg valproic acid


modified-release tablet


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Natriumvalproaat Chrono Winthrop 300 mg


200 mg sodium valproate and 87 mg valproic acid


modified-release tablet


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Natriumvalproaat Chrono Winthrop 500 mg


333 mg sodium valproate and 145 mg valproic acid


modified-release tablet


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Chronosphere


220 mg sodium valproate and 95,8 mg valproic acid per gram


modified-release granules


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Chronosphere 50 mg


33,33 sodium valproate and 14,51 mg valproic acid per sachet


modified-release granules


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Chronosphere 100 mg


66,66 sodium valproate and 29,03 mg valproic acid per sachet


modified-release granules


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Chronosphere 250 mg


166,76 sodium valproate and 72,61 mg valproic acid per sachet


modified-release granules


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Chronosphere 500 mg


333,30 sodium valproate and 145,14 mg valproic acid per sachet


modified-release granules


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Chronosphere 750 mg


500,06 sodium valproate and 217,75 mg valproic acid per sachet


modified-release granules


Oral Use




The Netherlands







sanofi-aventis Netherlands B.V.




Kampenringweg 45 D-E




NL-2803 PE Gouda




The Netherlands






Depakine Chronosphere 1 000 mg


666,60 sodium valproate and 290,27 mg valproic acid per sachet


modified-release granules


Oral Use




The Netherlands







Ratiopharm Nederland B.V.




Florapark 4




2012 HK Haarlem




The Netherlands






Natriumvalproaat ratiopharm chrono 300 mg


200 mg sodium valproate and 87 mg valproic acid


prolonged-release tablet


Oral Use




The Netherlands







Ratiopharm Nederland B.V.




Florapark 4




2012 HK Haarlem




The Netherlands






Natriumvalproaat ratiopharm chrono 500 mg


333 mg sodium valproate and 145 mg valproic acid


prolonged-release tablet


Oral Use




The Netherlands







Centrafarm Services BV




Nieuwe Donk 9




4879 AC Etten-Leur




The Netherlands






Natriumvalproaat Chrono CF 300 mg


200 mg sodium valproate and 87 mg valproic acid


prolonged-release tablet


Oral Use




The Netherlands







Centrafarm Services BV




Nieuwe Donk 9




4879 AC Etten-Leur




The Netherlands






Natriumvalproaat Chrono CF 500 mg


333 mg sodium valproate and 145 mg valproic acid


prolonged-release tablet


Oral Use




The Netherlands







Sandoz B.V.




Veluwezoom 22




NL-1327 AH Almere




The Netherlands






Natriumvalproaat Chrono Sandoz 300 mg


200 mg sodium valproate and 87 mg valproic acid


prolonged-release tablet


Oral Use




The Netherlands







Sandoz B.V.




Veluwezoom 22




NL-1327 AH Almere




The Netherlands






Natriumvalproaat Chrono Sandoz 500 mg


333 mg sodium valproate and 145 mg valproic acid


prolonged-release tablet


Oral Use




The Netherlands







Sandoz B.V.




Veluwezoom 22




NL-1327 AH Almere




The Netherlands






Natriumvalproaat Sandoz Chrono 300


200 mg sodium valproate and 87 mg valproic acid


prolonged-release tablet


Oral Use




The Netherlands







Sandoz B.V.




Veluwezoom 22




NL-1327 AH Almere




The Netherlands






Natriumvalproaat Sandoz Chrono 500


333 mg sodium valproate and 145 mg valproic acid


prolonged-release tablet


Oral Use




Slovakia







Orion Corporation




Orion Pharma




Orionintrie 1




02200 Espoo




Finland






Absenor 300 mg tablety s predĺženým uvoľňovaním


300 mg


prolonged-release tablet


Oral Use




Slovakia







Orion Corporation




Orion Pharma




Orionintrie 1




02200 Espoo




Finland






Absenor 500 mg tablety s predĺženým uvoľňovaním


500 mg


prolonged-release tablet


Oral Use




Slovakia







G.L. Pharma GmbH Schlossplatz 1




8502 Lannach




Austria






Convulex 150 mg kapsuly


150 mg


capsule


Oral Use




Slovakia







G.L. Pharma GmbH Schlossplatz 1




8502 Lannach




Austria






Convulex 300 mg kapsuly


300 mg


capsule


Oral Use




Slovakia







G.L. Pharma GmbH Schlossplatz 1




8502 Lannach




Austria






Convulex 500 mg kapsuly


500 mg


capsule


Oral Use




Slovakia







G.L. Pharma GmbH Schlossplatz 1




8502 Lannach




Austria






CONVULEX


50 mg/ml


syrup


Oral Use




Slovakia







G.L. Pharma GmbH Schlossplatz 1




8502 Lannach




Austria






Convulex 300 mg/ml kvapky


300 mg/ml


oral drops


Oral Use




Slovakia







Sanofi-aventis Slovakia, s.r.o.,




Žilinská 7-9




811 05 Bratislava




Slovakia






DEPAKINE


100 mg/ml


syrup


Oral Use




Slovakia







Sanofi-aventis Slovakia, s.r.o.,




Žilinská 7-9




811 05 Bratislava




Slovakia






DEPAKINE CHRONO 500 mg


500 mg


film-coated prolonged release tablet


Oral Use




Slovakia







Sanofi-aventis Slovakia, s.r.o.,




Žilinská 7-9




811 05 Bratislava




Slovakia






Depakine Chronosphere 50 mg


50 mg


modified-release granules


Oral Use




Slovakia







Sanofi-aventis Slovakia, s.r.o.,




Žilinská 7-9




811 05 Bratislava




Slovakia






Depakine Chronosphere 100 mg


100 mg


modified-release granules


Oral Use




Slovakia







Sanofi-aventis Slovakia, s.r.o.,




Žilinská 7-9




811 05 Bratislava




Slovakia






Depakine Chronosphere 250 mg


250 mg


modified-release granules


Oral Use




Slovakia







Sanofi-aventis Slovakia, s.r.o.,




Žilinská 7-9




811 05 Bratislava




Slovakia






Depakine Chronosphere 500 mg


500 mg


modified-release granules


Oral Use




Slovakia







Sanofi-aventis Slovakia, s.r.o.,




Žilinská 7-9




811 05 Bratislava




Slovakia






Depakine Chronosphere 750 mg


750 mg


modified-release granules


Oral Use




Slovakia







Sanofi-aventis Slovakia, s.r.o.,




Žilinská 7-9




811 05 Bratislava




Slovakia






Depakine Chronosphere 1 000 mg


1 000 mg


modified-release granules


Oral Use




Slovakia







Desitin Arzneimittel GmbH




Weg beim Jäger 214




22335 Hamburg




Germany






Orfiril 150


150 mg


gastro-resistant tablet


Oral Use




Slovakia







Desitin Arzneimittel GmbH




Weg beim Jäger 214




22335 Hamburg




Germany






Orfiril 300


300 mg


gastro-resistant tablet


Oral Use




Slovakia







Desitin Arzneimittel GmbH




Weg beim Jäger 214




22335 Hamburg




Germany






Orfiril 600


600 mg


gastro-resistant tablet


Oral Use




Slovakia







Desitin Arzneimittel GmbH




Weg beim Jäger 214




22335 Hamburg




Germany






Orfiril long 150 mg


150 mg


prolonged-release capsule


Oral Use




Slovakia







Desitin Arzneimittel GmbH




Weg beim Jäger 214




22335 Hamburg




Germany






Orfiril long 300 mg


300 mg


prolonged-release capsule


Oral Use




Slovakia







Desitin Arzneimittel GmbH




Weg beim Jäger 214




22335 Hamburg




Germany






Orfiril long 500 mg


500 mg


prolonged-release tablet


Oral Use




Slovakia







Desitin Arzneimittel GmbH




Weg beim Jäger 214




22335 Hamburg




Germany






Orfiril long 1 000 mg


1 000 mg


prolonged-release tablet


Oral Use




Slovakia







Ratiopharm GmbH




Graf-Arco-Strasse 3




89079 Ulm




Germany






Valpro-ratiopharm Chrono 500 mg


500 mg


prolonged-release tablet


Oral Use




Slovakia







Sandoz Pharmaceuticals d.d., Verovškova 57




1000 Ljubljana




Slovenia






Valproát chrono Sandoz 300 mg tablety s predĺženým uvoľňovaním


300 mg


prolonged-release tablet


Oral Use




Slovakia







Sandoz Pharmaceuticals d.d., Verovškova 57




1000 Ljubljana




Slovenia






Valproát chrono Sandoz 500 mg tablety s predľženým uvoľňovaním


500 mg


prolonged-release tablet


Oral Use




Slovenia







Sanofi-Aventis d.o.o.




Dunajska c. 119




1000 Ljubljana




Slovenia






Depakine chrono 500 mg filmsko obložene tablet s podaljšanim sproščanjem


500 mg


prolonged-release tablet


Oral Use




Slovenia







Sanofi-Aventis d.o.o.




Dunajska c. 119




1000 Ljubljana




Slovenia






Depakine chrono 300 mg filmsko obložene tablet s podaljšanim sproščanjem


300 mg


prolonged-release tablet


Oral Use




Spain







SANOFI AVENTIS, S.A.




Josep Plá, 2




08019 Barcelona




Spain






DEPAKINE 200 mg comprimidos gastrorresistentes


200 mg


gastro-resistant tablet


Oral Use




Spain







SANOFI AVENTIS, S.A.




Josep Plá, 2




08019 Barcelona




Spain






DEPAKINE solución oral


200 mg/ml


oral solution


Oral Use




Spain







SANOFI AVENTIS, S.A.




Josep Plá, 2




08019 Barcelona




Spain






DEPAKINE CRONO 500 mg comprimidos recubiertos


500 mg


coated tablet


Oral Use




Spain







SANOFI AVENTIS, S.A.




Josep Plá, 2




08019 Barcelona




Spain






DEPAKINE CRONO 300 mg comprimidos recubiertos


300 mg


coated tablet


Oral Use




Spain







SANOFI AVENTIS, S.A.




Josep Plá, 2




08019 Barcelona




Spain






DEPAKINE 500 mg comprimidos gastrorresistentes


500 mg


gastro-resistant tablet


Oral Use




Spain







SANOFI AVENTIS, S.A.




Josep Plá, 2




08019 Barcelona




Spain






DEPAKINE CHRONOSPHERE 100 MG Granulado de liberación modificada


100 mg


modified-release granules


Oral Use




Spain







SANOFI AVENTIS, S.A.




Josep Plá, 2




08019 Barcelona




Spain






DEPAKINE CHRONOSPHERE 250 mg granulado de liberación modificada


250 mg


modified-release granules


Oral Use




Spain







SANOFI AVENTIS, S.A.




Josep Plá, 2




08019 Barcelona




Spain






DEPAKINE CHRONOSPHERE 500 MG Granulado de liberación modificada


500 mg


modified-release granules


Oral Use




Spain







SANOFI AVENTIS, S.A.




Josep Plá, 2




08019 Barcelona




Spain






DEPAKINE CHRONOSPHERE 750 MG Granulado de liberación modificada


750 mg


modified-release granules


Oral Use




Spain







SANOFI AVENTIS, S.A.




Josep Plá, 2




08019 Barcelona




Spain






DEPAKINE CHRONOSPHERE 1 000 MG Granulado de liberación modificada


1 000 mg


modified-release granules


Oral Use




Spain







WINTHROP PHARMA ESPAÑA, S.A.




Josep Plá, 2




08019 Barcelona




Spain






VALPROATO SODICO CRONO WINTHROP 300 mg comprimidos de liberación prolongada


300 mg


prolonged-release tablet


Oral Use




Spain







WINTHROP PHARMA ESPAÑA, S.A.




Josep Plá, 2




08019 Barcelona




Spain






VALPROATO SODICO CRONO WINTHROP 500 mg comprimidos de liberación prolongada


500 mg


prolonged-release tablet


Oral Use




Spain







DESITIN ARZNEIMITTEL GMBH




Weg beim Jäger 214




Hamburgo D-22335




Germany






MILZONE 300 MG CÁPSULAS DURAS DE LIBERACIÓN PROLONGADA


300 mg


prolonged-release capsule


Oral Use




Spain







DESITIN ARZNEIMITTEL GMBH




Weg beim Jäger 214




Hamburgo D-22335




Germany






MILZONE 1 000 MG GRÁNULOS DE LIBERACIÓN PROLONGADA


1 000 mg


prolonged -release granules


Oral Use




Spain







DESITIN ARZNEIMITTEL GMBH




Weg beim Jäger 214




Hamburgo D-22335




Germany






MILZONE 500 MG GRÁNULOS DE LIBERACIÓN PROLONGADA


500 mg


prolonged -release granules


Oral Use




Spain







DESITIN ARZNEIMITTEL GMBH




Weg beim Jäger 214




Hamburgo D-22335




Germany






MILZONE 300 MG CÁPSULAS DURAS DE LIBERACIÓN PROLONGADA


300 mg


prolonged-release capsule


Oral Use




Sweden







Orion Corporation




Orionintie




FI-02200 Espoo




Finland






Absenor


200 mg/ml


oral drops, solution


Oral Use




Sweden







Orion Corporation




Orionintie




FI-02200 Espoo




Finland






Absenor


300 mg


tablet


Oral Use




Sweden







Orion Corporation




Orionintie




FI-02200 Espoo




Finland






Absenor


100 mg


gastro-resistant tablet


Oral Use




Sweden







Orion Corporation




Orionintie




FI-02200 Espoo




Finland






Absenor


300 mg


gastro-resistant tablet


Oral Use




Sweden







Orion Corporation




Orionintie




FI-02200 Espoo




Finland






Absenor


500 mg


gastro-resistant tablet


Oral Use




Sweden







Orion Corporation




Orionintie




FI-02200 Espoo




Finland






Absenor


60 mg/ml


oral solution


Oral Use




Sweden







Orion Corporation




Orionintie




FI-02200 Espoo




Finland






Absenor Depot


300 mg


prolonged-release tablet


Oral Use




Sweden







Orion Corporation




Orionintie




FI-02200 Espoo




Finland






Absenor Depot


500 mg


prolonged-release tablet


Oral Use




Sweden







Sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Ergenyl


200 mg/ml


oral drops, solution


Oral Use




Sweden







Sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Ergenyl


100 mg


gastro-resistant tablet


Oral Use




Sweden







Sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Ergenyl


300 mg


gastro-resistant tablet


Oral Use




Sweden







Sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Ergenyl


500 mg


gastro-resistant tablet


Oral Use




Sweden







Sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Ergenyl


60 mg/ml


oral solution


Oral Use




Sweden







Sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Ergenyl Retard


300 mg


prolonged-release tablet


Oral Use




Sweden







Sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Ergenyl Retard


500 mg


prolonged-release tablet


Oral Use




Sweden







Sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Ergenyl Retard


100 mg


prolonged-release granules


Oral Use




Sweden







Sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Ergenyl Retard


250 mg


prolonged-release granules


Oral Use




Sweden







Sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Ergenyl Retard


500 mg


prolonged-release granules


Oral Use




Sweden







Sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Ergenyl Retard


750 mg


prolonged-release granules


Oral Use




Sweden







Sanofi-aventis AB




Box 14142




167 14 Bromma




Sweden






Ergenyl Retard


1 000 mg


prolonged-release granules


Oral Use




Sweden







Desitin Arzneimittel GmbH




Weg Beim Jäger 214




223 35 Hamburg




Germany






Orfiril


150 mg


gastro-resistant tablet


Oral Use




Sweden







Desitin Arzneimittel GmbH




Weg Beim Jäger 214




223 35 Hamburg




Germany






Orfiril


300 mg


gastro-resistant tablet


Oral Use




Sweden







Desitin Arzneimittel GmbH




Weg Beim Jäger 214




223 35 Hamburg




Germany






Orfiri long


150 mg


prolonged-release capsule, hard


Oral Use




Sweden







Desitin Arzneimittel GmbH




Weg Beim Jäger 214




223 35 Hamburg




Germany






Orfiril long


300 mg


prolonged-release capsule, hard


Oral Use




Sweden







Desitin Arzneimittel GmbH




Weg Beim Jäger 214




223 35 Hamburg




Germany






Orfiril long


500 mg


prolonged-release granules


Oral Use




Sweden







Desitin Arzneimittel GmbH




Weg Beim Jäger 214




223 35 Hamburg




Germany






Orfiril long


1 000 mg


prolonged-release granules


Oral Use




United Kingdom







Actavis UK Limited




Whiddon Valley




Barnstaple




North Devon




EX32 8NS




United Kingdom






SODIUM VALPROATE TABLETS BP 200 MG (E/C)


200 mg


gastro-resistant tablet


Oral Use




United Kingdom







TEVA UK LIMITED




Brampton Road




Hampden Park




Eastbourne




East Sussex




BN22 9AG




United Kingdom






SODIUM VALPROATE ENTERIC COATED TABLETS 200 MG


200 mg


coated tablet


Oral Use




United Kingdom







TEVA UK LIMITED




Brampton Road




Hampden Park




Eastbourne




East Sussex




BN22 9AG




United Kingdom






SODIUM VALPROATE ENTERIC COATED TABLETS 500 MG


500 mg


coated tablet


Oral Use




United Kingdom







NORTON HEALTHCARE LIMITED




Albert Basin, Royal Dock




Canning Town




London E16 2QJ




United Kingdom






SODIUM VALPROATE ORAL SOLUTION BP 200 MG/5 ML


200 mg/5 ml


oral solution


Oral Use




United Kingdom







AVENTIS PHARMA LIMITED




50 Kings Hill Avenue




Kings Hill




West Malling, Kent. ME194AH




United Kingdom






DEPAKOTE 250 MG TABLETS


250 mg


gastro-resistant tablet


Oral Use




United Kingdom







AVENTIS PHARMA LIMITED




50 Kings Hill Avenue




Kings Hill




West Malling, Kent. ME194AH




United Kingdom






DEPAKOTE 500 MG TABLETS


500 mg


gastro-resistant tablet


Oral Use




United Kingdom







AVENTIS PHARMA LIMITED




50 Kings Hill Avenue




Kings Hill




West Malling, Kent. ME194AH




United Kingdom






EPILIM CHRONOSPHERE MR 50 MG MODIFIED RELEASE GRANULES


50 mg


modified-release granules


Oral Use




United Kingdom







AVENTIS PHARMA LIMITED




50 Kings Hill Avenue




Kings Hill




West Malling, Kent. ME194AH




United Kingdom






EPILIM CHRONOSPHERE MR 100 MG MODIFIED RELEASE GRANULES


100 mg


modified-release granules


Oral Use




United Kingdom







AVENTIS PHARMA LIMITED




50 Kings Hill Avenue




Kings Hill




West Malling, Kent. ME194AH




United Kingdom






EPILIM CHRONOSPHERE MR 250 MG MODIFIED RELEASE GRANULES


250 mg


modified-release granules


Oral Use




United Kingdom







AVENTIS PHARMA LIMITED




50 Kings Hill Avenue




Kings Hill




West Malling, Kent. ME194AH




United Kingdom






EPILIM CHRONOSPHERE MR 500 MG MODIFIED RELEASE GRANULES


500 mg


modified-release granules


Oral Use




United Kingdom







AVENTIS PHARMA LIMITED




50 Kings Hill Avenue




Kings Hill




West Malling, Kent. ME194AH




United Kingdom






EPILIM CHRONOSPHERE MR 750 MG MODIFIED RELEASE GRANULES


750 mg


modified-release granules


Oral Use




United Kingdom







AVENTIS PHARMA LIMITED




50 Kings Hill Avenue




Kings Hill




West Malling, Kent. ME194AH




United Kingdom






EPILIM CHRONOSPHERE MR 1 000 MG MODIFIED RELEASE GRANULES


1 000 mg


modified-release granules


Oral Use




United Kingdom







GENERICS (UK) LIMITED




Station Close




Potters Bar




Herts, EN6 1TL




United Kingdom






SODIUM VALPROATE TABLETS BP 200 MG


200 mg


coated tablet


Oral Use




United Kingdom







GENERICS (UK) LIMITED




Station Close




Potters Bar




Herts, EN6 1TL




United Kingdom






SODIUM VALPROATE TABLETS BP 500 MG EC


500 mg


coated tablet


Oral Use




United Kingdom







GEROT PHARMAZEUTIKA GES.M.B.H




Arnethgasse 3




A-1160, Vienna




Austria






CONVULEX CAPSULES 300 MG


300 mg


gastro-resistant capsule


Oral Use




United Kingdom







GEROT PHARMAZEUTIKA GES.M.B.H




Arnethgasse 3




A-1160, Vienna




Austria






CONVULEX CAPSULES 500 MG


500 mg


gastro-resistant capsule


Oral Use




United Kingdom







GEROT PHARMAZEUTIKA GES.M.B.H




Arnethgasse 3




A-1160, Vienna




Austria






CONVULEX CAPSULES 150 MG


150 mg


gastro-resistant capsule


Oral Use




United Kingdom







GEROT PHARMAZEUTIKA GES.M.B.H




Arnethgasse 3




A-1160, Vienna




Austria






CONVULEX CR 300 MG PROLONGED RELEASE TABLETS


300 mg


prolonged-release tablet


Oral Use




United Kingdom







GEROT PHARMAZEUTIKA GES.M.B.H




Arnethgasse 3,




A-1160, Vienna,




Austria






CONVULEX CR 500 MG PROLONGED RELEASE TABLETS


500 mg


modified-release tablet


Oral Use




United Kingdom







GEROT PHARMAZEUTIKA GES.M.B.H




Arnethgasse 3




A-1160, Vienna




Austria






EPIVAL CR 500 MG PROLONGED RELEASE TABLETS


500 mg


prolonged-release tablet


Oral Use




United Kingdom







GEROT PHARMAZEUTIKA GES.M.B.H




Arnethgasse 3




A-1160, Vienna




Austria






EPIVAL CR 300 MG PROLONGED RELEASE TABLETS


300 mg


prolonged-release tablet


Oral Use




United Kingdom







SANOFI-SYNTHELABO LIMITED




1 Onslow Street




Guildford, Surrey




GU1 4YS




United Kingdom






EPILIM 100 MG CRUSHABLE TABLET


100 mg


tablet


Oral Use




United Kingdom







SANOFI-SYNTHELABO LIMITED




1 Onslow Street




Guildford, Surrey




GU1 4YS




United Kingdom






EPILIM 200 EC TABLETS


200 mg


gastro-resistant tablet


Oral Use




United Kingdom







SANOFI-SYNTHELABO LIMITED




1 Onslow Street




Guildford, Surrey




GU1 4YS




United Kingdom






EPILIM 500 ENTERIC COATED TABLETS


500 mg


gastro-resistant tablet


Oral Use




United Kingdom







SANOFI-SYNTHELABO LIMITED




1 Onslow Street




Guildford, Surrey




GU1 4YS




United Kingdom






EPILIM CHRONO 300 CONTROLLED RELEASE


300 mg


modified-release tablet


Oral Use




United Kingdom







SANOFI-SYNTHELABO LIMITED




1 Onslow Street




Guildford, Surrey




GU1 4YS




United Kingdom






EPILIM LIQUID OR SODIUM VALPROATE 200 MG/5 ML LIQUID


200 mg/5 ml


oral solution


Oral Use




United Kingdom







SANOFI-SYNTHELABO LIMITED




1 Onslow Street




Guildford, Surrey




GU1 4YS




United Kingdom






EPILIM SYRUP 200 MG/5 ML


200 mg/5 ml


oral solution


Oral Use




United Kingdom







SANOFI-SYNTHELABO LIMITED




1 Onslow Street




Guildford, Surrey




GU1 4YS




United Kingdom






EPILIM CHRONO 200 CONTROLLED RELEASE TABLETS 200 MG


200 mg


modified-release tablet


Oral Use




United Kingdom







SANOFI-SYNTHELABO LIMITED




1 Onslow Street




Guildford, Surrey




GU1 4YS




United Kingdom






EPILIM CHRONO 500 CONTROLLED RELEASE TABLETS 500 MG


500 mg


modified-release tablet


Oral Use




United Kingdom







WINTHROP PHARMACEUTICALS UK LIMITED




1 Onslow Street




Guildford Surrey,




GU1 4YS




United Kingdom






SODIUM VALPROATE 200 MG ENTERIC COATED TABLETS


200 mg


gastro-resistant tablet


Oral Use




United Kingdom







WINTHROP PHARMACEUTICALS UK LIMITED




1 Onslow Street,




Guildford Surrey,




GU1 4YS




United Kingdom






SODIUM VALPROATE 500 MG ENTERIC COATED TABLETS


500 mg


gastro-resistant tablet


Oral Use




United Kingdom







RATIOPHARM GMBH




Graff-Arco Strasse 3, Ulm, D-89079




Germany






VALPROTEK CR 300 MG (PROLONGED RELEASE) TABLETS


300 mg


prolonged-release tablet


Oral Use




United Kingdom







RATIOPHARM GMBH




Graff-Arco Strasse 3, Ulm, D-89079




Germany






VALPROTEK CR 500 MG (PROLONGED RELEASE) TABLETS


500 mg


prolonged-release tablet


Oral Use




United Kingdom







WINTHROP PHARMACEUTICALS UK LIMITED




1 Onslow Street, Guildford




Surrey, GU1 4YS




United Kingdom






SODIUM VALPROATE LIQUID 200 MG/5 ML


200 mg


oral solution


Oral Use




United Kingdom







WINTHROP PHARMACEUTICALS UK LIMITED




1 Onslow Street, Guildford




Surrey, GU1 4YS




United Kingdom






MAPHILEP 200 MG MR TABLETS


200 mg


prolonged-release tablet


Oral Use




United Kingdom







WINTHROP PHARMACEUTICALS UK LIMITED




1 Onslow Street, Guildford




Surrey, GU1 4YS




United Kingdom






MAPHILEP 300 MG MR TABLETS


300 mg


modified release tablet


Oral Use




United Kingdom







WINTHROP PHARMACEUTICALS UK LIMITED




1 Onslow Street, Guildford




Surrey, GU1 4YS




United Kingdom






MAPHILEP 500 MG MR TABLETS


500 mg


modified release tablet


Oral Use




United Kingdom







BEACON PHARMACEUTICALS LIMITED




85 High Street




Tunbridge Wells, TN1 1YG




United Kingdom






EPISENTA 150 MG PROLONGED-RELEASE CAPSULE


150 mg


prolonged-release capsule, hard


Oral Use




United Kingdom







BEACON PHARMACEUTICALS LIMITED




85 High Street




Tunbridge Wells, TN1 1YG




United Kingdom






EPISENTA 300 MG PROLONGED-RELEASE CAPSULE


300 mg


prolonged-release capsule, hard


Oral Use




United Kingdom







BEACON PHARMACEUTICALS LIMITED




85 High Street




Tunbridge Wells, TN1 1YG




United Kingdom






EPISENTA 500 MG PROLONGED-RELEASE GRANULES


500 mg


prolonged-release granules


Oral Use




United Kingdom







BEACON PHARMACEUTICALS LIMITED




85 High Street




Tunbridge Wells, TN1 1YG




United Kingdom






EPISENTA 1 000 MG PROLONGED-RELEASE GRANULES


1 000 mg


prolonged-release granules


Oral Use




United Kingdom







WOCKHARDT UK LIMITED




Ash Road North




Wrexham Industrial Estate




Wrexham, LL13 9UF




United Kingdom






ORLEPT (SF) LIQUID OR SODIUM VALPROATE 40 MG/ML ORAL SOLUTION


40 mg/ml


oral solution


Oral Use




United Kingdom







WOCKHARDT UK LIMITED




Ash Road North




Wrexham Industrial Estate




Wrexham, LL13 9UF




United Kingdom






ORLEPT 200 MG GASTRO-RESISTANT TABLETS


200 mg


gastro-resistant tablet


Oral Use




United Kingdom







WOCKHARDT UK LIMITED




Ash Road North




Wrexham Industrial Estate




Wrexham, LL13 9UF




United Kingdom






ORLEPT 500 MG GASTRO-RESISTANT TABLETS


500 mg


gastro-resistant tablet


Oral Use







ANNEX V

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State


Marketing Authorisation Holder


Product name


Strength


Pharmaceutical Form


Route of Administration




Austria







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






Dotarem - Injektionslösung


279,32 mg/ml


solution for injection


intravenous use




Austria







Insight Agents GmbH




Ringstrasse 19 B




69115 Heidelberg




Germany






Gadopentetsäure Insight 500 Mikromol/ml Injektionslösung


469 mg/ml Gadopentetat-Dimeglumin (78,63 mg/ml Gadolinium)


solution for injection


intravenous use




Austria







Bayer Austria GmbH




Herbststrasse 6-10




1160 Wien




Austria






Gadovist 1,0 mmol/ml Injektionslösung in Fertigspritzen/Patronen


604,72 mg/ml Gadobutrol (157,25 mg/ml Gadolinium)


solution for injection


intravenous use




Austria







Bayer Austria GmbH,




Herbststrasse 6-10




1160 Wien




Austria






Gadovist 1,0 mmol/ml - Injektionslösung


604,72 mg/ml Gadobutrol (157,25 mg/ml Gadolinium)


solution for injection


intravenous use




Austria







Insight Agents GmbH




Ringstrasse 19 B




69115 Heidelberg




Germany






Magnegita 500 Mikromol/ml Injektionslösung


469 mg/ml Gadopentetat-Dimeglumin (78,63 mg/ml Gadolinium)


solution for injection


intravenous use




Austria







Bayer Austria GmbH,




Herbststrasse 6-10




1160 Wien




Austria






Magnevist 0,5 mmol/ml - Injektionslösung


469 mg/ml Gadopentetsäure Dimeglumin


solution for injection/infusion


intravenous use




Austria







Bracco S.p.A.




Via Egidio Folli, 50




20134 Milano




Italy






MultiHance 0,5 M - Injektionslösung


334 mg/ml Gadobensäure Dimeglumin


solution for injection


intravenous use




Austria







Bracco S.p.A.




Via Egidio Folli, 50




20134 Milano




Italy






MultiHance 0,5 mmol/ml Injektionslösung in einer Fertigspritze


334 mg/ml Gadobensäure Dimeglumin


solution for injection


intravenous use




Austria







GE Healthcare Handels GmbH




Europlaza Gebäude E




Technologiestr. 10




1120 Wien




Austria






Omniscan 0,5 mmol/ml - parenterale Kontrastmittellösung


287 mg/ml Gadodiamid


solution for injection


intravenous use




Austria







Bayer Austria GmbH,




Herbststrasse 6-10




1160 Wien




Austria






Primovist 0,25 mmol/m Injektionslösung in einer Fertigspritze


181,43 mg/ml Gadoxetsäure-Dinatrium


solution for injection


intravenous use




Austria







Bayer Austria GmbH,




Herbststrasse 6-10




1160 Wien




Austria






Primovist 0,25 mmol/ml Injektionslösung in einer Durchstechflasche


181,43 mg/ml Gadoxetsäure-Dinatrium


solution for injection


intravenous use




Austria







Bracco S.p.A.




Via Egidio Folli, 50




20134 Milano




Italy






Prohance - Injektionslösung


279,3 mg/ml Gadoteridol (78,61 mg/ml Gadolinium)


solution for injection


intravenous use




Belgium







Codali S.A.




Avenue Henri Dunant 31




1140 Bruxelles




Belgium






DOTAREM


0,5 mmol/ml


Solution for injection


intravenous use




Belgium







Insight Agents GmbH




Ringstrasse 19 B




69115 Heidelberg




Germany






GADOPENTETATE CURAGITA 500 MICROMOL/ML


500 micromol/ml


Solution for injection


intravenous use




Belgium







Bayer SA-NV




J.E. Mommaertslaan 14




1831 Diegem




Belgium






GADOVIST


1,0 mmol-ml


Solution for injection


intravenous use




Belgium







Insight Agents GmbH




Ringstraat 19 B




69115 Heidelberg




Germany






MAGNEGITA


500 micromol-ml


Solution for injection


intravenous use




Belgium







Bayer SA-NV




J.E. Mommaertslaan 14




1831 Diegem




Belgium






MAGNEVIST


0,5 mmol-ml


Solution for injection


intravenous use




Belgium







BRACCO Imaging Deutschland GmbH




Max-Stromeyer-Strasse 116




D - 78467 Konstanz




Germany






MULTIHANCE


0,5 M


Solution for injection


intravenous use




Belgium







GE HEALTHCARE BVBA




Kouterveldstraat 20




1831 DIEGEM




Belgium






OMNISCAN


0,5 mmol-ml


Solution for injection


intravenous use




Belgium







Bayer SA-NV




J.E. Mommaertslaan 14




1831 Diegem




Belgium






PRIMOVIST


0,25 mmol-ml


Solution for injection


intravenous use




Belgium







BRACCO Imaging Deutschland GmbH




Max-Stromeyer-Strasse 116




D - 78467 Konstanz




Germany






PROHANCE


279,3 mg-ml


Solution for injection


intravenous use




Bulgaria







Bayer Schering Pharma AG




Muellerstrasse 178




13353 Berlin




Germany






Gadovist


604,72 mg/ml


solution for injection


intravenous use




Bulgaria







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Primovist


181,43 mg/ml


solution for injection


intravenous use




Bulgaria







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Magnevist


469 mg/ml


solution for injection


intravenous use




Bulgaria







GE Healthcare AS




Nycoveien 1-2




P.O.Box 4220 Nydalen




N-0401 Oslo




Norway






Omniscan


287 mg/ml


solution for injection


intravenous use




Bulgaria







Insight Agents GmbH




Ringstrasse 19 B




D–69115, Heidellberg




Germany






Magnegita


500 micromol/ml


Solution for injection


Intravenous use




Cyprus







PHADISCO LTD




185 YIANNOU GRANIDIOTI AVE,




2235 LATSIA




CYPRUS






OMNISCAN


0,5 MMOL/ML


solution for injection


intravenous use




Cyprus







BAYER HELLAS ABEE




SOROU 18-20




151 25 MAROUSI, ATHENS,




GREECE






PRIMOVIST PFS


0,25 MMOL/ML


solution for injection in prefilled syringes


intravenous use




Cyprus







BAYER HELLAS ABEE




SOROU 18-20




151 25 MAROUSI, ATHENS,




GREECE






PRIMOVIST


0,25 MMOL/ML


solution for injection


intravenous use




Czech Republic







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






GADOVIST 1,0 m mol/ml


1 mmol/l


solution for injection


intravenous use




Czech Republic







Insight Agents GmbH




Ringstrasse 19 B




69115 Heidelberg




Germany






Magnegita 500 mikromol/ml injekční roztok


0,5 mmo/ml


solution for injection


intravenous use




Czech Republic







Bracco Imaging Deutschland GmbH




Max-Stromeyer-Strasse 116




D-78467 Konstanz




Germany






ProHance


279,3 mg-ml


solution for injection


intravenous use




Czech Republic







Bracco Imaging Deutschland GmbH




Max-Stromeyer-Strasse 116




D-78467 Konstanz




Germany






MultiHance


529 mg/ml


solution for injection


intravenous use




Czech Republic







GE Healthcare AS




Nycoveien 1-2,




P.O.Box 4220




Nydalen




N-0401 Oslo




Norway






Omniscan 0,5 mmol/l


287 mg/ml


solution for injection


intravenous use




Czech Republic







Guerbet




BP 57400




95943 Roissy CdG cedex




France






Dotarem


279,32 mg/ml


solution for injection


intravenous use




Czech Republic







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Primovist 0,25 mmol/ml


0,25 mmol/ml


solution for injection


intravenous use




Germany







BRACCO Imaging Deutschland GmbH




Max-Stromeyer-Strasse 116




D - 78467 Konstanz




Germany






MultiHance


529 mg/ml


solution for injection


intravenous use




Germany







BRACCO Imaging Deutschland GmbH




Max-Stromeyer-Strasse 116




D - 78467 Konstanz




Germany






MultiHance


0,5 mmol/ml


solution for injection, prefilled syringe


intravenous use




Germany







BRACCO Imaging Deutschland GmbH




Max-Stromeyer-Strasse 116




D - 78467 Konstanz




Germany






MultiHance XL


529 mg/ml


solution for injection


intravenous use




Germany







Bayer Vital GmbH




D-51368 Leverkusen




Germany






Gadovist 1,0 mmol/ml Injektioslösung


604,72 mg/ml


solution for injection


intravenous use




Germany







Bayer Vital GmbH




D-51368 Leverkusen




Germany






Gadovist 1,0 mmol/ml Injektioslösung in Fertigspritzen/Patronen


604,72 mg/ml


solution for injection


intravenous use




Germany







Marotrast GmbH




Otto-Schott-Str. 15




D-07745 Jena




Germany






Gadograf 1,0 mmol/ml Injektionslösung in Fertigspritzen


604,72 mg/ml


solution for injection


intravenous use




Germany







Marotrast GmbH




Otto-Schott-Str. 15




D-07745 Jena




Germany






Gadograf 1,0 mmol/ml


604,72 mg/ml


solution for injection


intravenous use




Germany







GE Healthcare Buchler GmbH & Co.KG




Gieselweg 1




D-38110 Braunschweig




Germany






Omniscan 0,5 mmol/ml Injektioslösung


287 mg/ml


solution for injection


intravenous use




Germany







GE Healthcare Buchler GmbH & Co.KG




Gieselweg 1




D-38110 Braunschweig




Germany






Omniscan 0,5 mmol/ml Injektioslösung in Fertigspritzen


287 mg/ml


solution for injection


intravenous use




Germany







Guerbet




15 rue des Vanesses




Zone Paris Nord II




F-83420 VILLEPINTE




France






Dotarem 0,5 mmol/ml Injektionslösung in Fertigspritzen


279,32 mg/ml


solution for injection


intravenous use




Germany







Guerbet




15 rue des Vanesses




Zone Paris Nord II




F-83420 VILLEPINTE




France






Dotarem 0,5 mmol/ml Injektionslösung in Durchstechflaschen (für Mehrfachentnahme)


279,32 mg/ml


solution for injection


intravenous use




Germany







Guerbet




15 rue des Vanesses




Zone Paris Nord II




F-83420 VILLEPINTE




France






Dotarem 0,5 mmol/ml Injektionslösung in Durchstechflaschen


279,32 mg/ml


solution for injection


intravenous use




Germany







Bayer Vital GmbH




D-51368 Leverkusen




Germany






Magnevist 0,5 mmol/ml, Injektionslösung


469,01 mg/ml


solution for injection


intravenous use




Germany







Bayer Vital GmbH




D-51368 Leverkusen




Germany






Gadopentetat-Dimeglumin 0,5 mmol/ml, Injektionslösung


469,01 mg/ml


solution for injection


intravenous use




Germany







be imaging GmbH




Dr.-Rudolf-Eberle-Str. 8-10




D-76534 Baden-Baden




Germany






Magnevision 0,5 mmol/ml Injektionslösung


469 mg/ml


solution for injection


intravenous use




Germany







Covidien Deutschland GmbH




Gewerbepark 1




D-93333 Neustadt




Germany






Marktiv 500 Mikromol/ml Injektionslösung


469 mg/ml


solution for injection


intravenous use




Germany







be imaging GmbH




Dr.-Rudolf-Eberle-Str. 8-10




D-76534 Baden-Baden




Germany






Magnevision b.e. 0,5 mmol/ml Injektionslösung


469 mg/ml


solution for injection


intravenous use




Germany







Helm AG




Nordkanalstr. 28




D-20097 Hamburg




Germany






Gadopentetat Dimeglumin Helm AG Injektionslösung


469 mg/ml


solution for injection


intravenous use




Germany







Insight Agents GmbH




Ringstr. 19 B




D-69115 Heidelberg




Germany






Magnegita 500 Mikromol/ml Injektionslösung


469,01 mg/ml


solution for injection


intravenous use




Germany







Insight Agents GmbH




Ringstr. 19 B




D-69115 Heidelberg




Germany






Gadopentetat Insight 500 Mikromol/ml Injektionslösung


469,01 mg/ml


solution for injection


intravenous use




Germany







Marotrast GmbH




Otto-Schott-Str. 15




D-07745 Jena




Germany






Magnograf 0,5 mmol/ml, Injektionslösung


469,01 mg/ml


solution for injection


intravenous use




Germany







ratiopharm GmbH




Graf-Arco-Str. 3




D-89079 Ulm




Germany






Gadopentetat-MRT-ratiopharm


469 mg/ml


solution for injection


intravenous use




Germany







Sanochemia Diagnostics Deutschland GmbH




Stresemannallee 4 c




D-41460 Neuss




Germany






MR-Lux


469 mg/ml


solution for injection


intravenous use




Germany







Bracco IMAGING Deutschland GmbH




Max-Stromexer-Str. 116




D-78467 Konstanz




Germany






ProHance


279,3 mg/ml


solution for injection


intravenous use




Germany







Bayer Vital GmbH




D-51368 Leverkusen




Germany






Primovist 0,25 mml/ml Injektionslösung, Fertigspritze


181,43 mg/ml


solution for injection


intravenous use




Germany







Bayer Vital GmbH




D-51368 Leverkusen




Germany






Primovist 0,25 mml/ml Injektionslösung, Durchstechflasche


181,43 mg/ml


solution for injection


intravenous use




Denmark







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






Dotarem


279,3 mg/mL


solution for injection


intravenous use




Denmark







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






Dotarem


279,3 mg/mL


Solution for injection, prefilled syringe


intravenous use




Denmark







GE Healthcare AS




Nycoveien 1-2, 4220 Nydalen,




Oslo N-0401




Norway






Omniscan


0,5 mmol/mL


solution for injection


intravenous use




Denmark







Insight Agents GmbH




Ringstr. 19 B




D-69115 Heidelberg




Germany






Magnegita


0,5 mmol/mL


solution for injection


intravenous use




Denmark







Insight Agents GmbH




Ringstr. 19 B




D-69115 Heidelberg




Germany






Gadopentetat ‘Insight’


0,5 mmol/mL


solution for injection


intravenous use




Denmark







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Gadovist


1 mmol/mL


solution for injection


intravenous use




Denmark







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Gadovist PFS


1 mmol/mL


solution for injection, prefilled syringe


intravenous use




Denmark







Bracco International B.V




Strawinskylaan 3051




NL-1077 ZX Amsterdam




Netherlands






Prohance


279,3 mg/mL


solution for injection


intravenous use




Denmark







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Magnevist


469 mg/mL


solution for injection


intravenous use




Denmark







Bracco S.p.A.




Via Emilio Folli, 50




20134 Milano




Italy






Multihance


334 mg/ml


solution for injection


intravenous use




Denmark







Bracco S.p.A.




Via Emilio Folli, 50




20134 Milano




Italy






Multihance


334 mg


Solution for injection, prefilled syringe


intravenous use




Estonia







Bayer Schering Pharma AG




DE-13342 Berlin-




Germany






MAGNEVIST


469 mg/ml


solution for injection


intravenous use




Estonia







GE Healthcare AS




PO 4220, Nycoveien 1-2




NO-0401 Nydalen




Norway






OMNISCAN


0,5 mmol/ml


solution for injection


intravenous use




Estonia







Bayer Schering Pharma AG




DE-13342 Berlin-




Germany






GADOVIST


1 mmol/ml


solution for injection


intravenous use




Estonia







Bayer Schering Pharma AG




DE-13342 Berlin-




Germany






PRIMOVIST


0,25 mmol/ml


solution for injection


intravenous use




Estonia







Bayer Schering Pharma AG




DE-13342 Berlin-




Germany






PRIMOVIST


0,25 mmol/ml


solution for injection inpre-filled syringe


intravenous use




Estonia







Insight Agents GmbH




Ringstr. 19 B




D-69115 Heidelberg




Germany






MAGNEGITA


469 mg/ml


solution for injection


intravenous use




Spain







GE HEALTHCARE BIO-SCIENCES S.A.




Avda. de Europa




22 Alcobendas 28108 Madrid




Spain






OMNISCAN


0,5 mmol/ml


solution for injection syringe


intravenous use




Spain







GE HEALTHCARE BIO-SCIENCES S.A.




Avda. de Europa




22 Alcobendas 28108 Madrid




Spain






OMNISCAN


0,5 mmol/ml


solution for injection


intravenous use




Spain







Bracco S.p.A.




Via Egido Folli, 50




20134 Milano




Italy






MULTIHANCE


0,5 M


solution for injection


intravenous use




Spain







QUIMICA FARMACEUTICA BAYER S.L.




Av. Baix Llobregat




3-5 Sant Joan Despi




Barcelona 08970




Spain






PRIMOVIST


0,25 mmol/ml


solution for injection


intravenous use




Spain







QUIMICA FARMACEUTICA BAYER S.L.




Av. Baix Llobregat




3-5 Sant Joan Despi




Barcelona 08970




Spain






PRIMOVIST


0,25 mmol/ml


solution for injection (syringe)


intravenous use




Spain







Bracco International B.V




Strawinskylaan 3051




NL-1077 ZX Amsterdam




Netherlands






PROHANCE


(0,5 M)


solution for injection (syringe)


intravenous use




Spain







Bracco International B.V




Strawinskylaan 3051




NL-1077 ZX Amsterdam




Netherlands






PROHANCE


(0,5 M)


solution for injection (vial)


intravenous use




Spain







QUIMICA FARMACEUTICA BAYER S.L.




Av. Baix Llobregat




3-5 Sant Joan Despi




Barcelona 08970




Spain






GADOVIST


1,0 mmol/ml


solution for injection (vial)


intravenous use




Spain







QUIMICA FARMACEUTICA BAYER S.L.




Av. Baix Llobregat




3-5 Sant Joan Despi




Barcelona 08970




Spain






GADOVIST


1,0 mmol/ml


solution for injection (syringe and cartridge)


intravenous use




Spain







QUIMICA FARMACEUTICA BAYER S.L.




Av. Baix Llobregat




3-5 Sant Joan Despi




Barcelona 08970




Spain






MAGNEVIST


0,5 mmol/ml


solution for injection


intravenous use




Spain







QUIMICA FARMACEUTICA BAYER S.L.




Av. Baix Llobregat




3-5 Sant Joan Despi




Barcelona 08970




Spain






MAGNEVIST


0,5 mmol/ml


solution for injection (syringe)


intravenous use




Spain







QUIMICA FARMACEUTICA BAYER S.L.




Av. Baix Llobregat




3-5 Sant Joan Despi




Barcelona 08970




Spain






MAGNOGRAF


0,5 mmol/ml


solution for injection


intravenous use




Spain







QUIMICA FARMACEUTICA BAYER S.L.




Av. Baix Llobregat




3-5 Sant Joan Despi




Barcelona 08970




Spain






MAGNOGRAF


0,5 mmol/ml


solution for injection (syringe)


intravenous use




Spain







Guerbet




BP 57400




95493 Roissy CdG cedex




France






Dotarem


0,5 mmol/ml


solution for injection


intravenous use




Spain







Guerbet




BP 57400




95493 Roissy CdG cedex




France






Dotarem


0,5 mmol/ml


solution for injection (syringe)


intravenous use




Finland







GE Healthcare AS




Nycoveien 1-2




4220 Nydalen,




Oslo N-0401




Norway






OMNISCAN


0,5 mmol/ml


Solution for injection


intravenous use




Finland







Bayer Schering Pharma Oy




Pansiontie 47




20210 Turku




Finland






MAGNEVIST


0,5 mmol/ml


solution for injection


intravenous use




Finland







Insight Agents GmbH




Ringstr. 19 B,




69115 HEIDELBERG




Germany






MAGNEGITA


500 micromol/ml


solution for injection


intravenous use




Finland







Insight Agents GmbH




Ringstr. 19 B,




69115 HEIDELBERG




Germany






GADOPENTETATE INSIGHT


500 micromol/ml


solution for injection


intravenous use




Finland







Bracco S.p.A.




Via Emilio Folli, 50




20134 Milano




Italy






MULTIHANCE


334 mg/ml


solution for injection


intravenous use




Finland







Bracco S.p.A.




Via Emilio Folli, 50




20134 Milano




Italy






MULTIHANCE


334 mg/ml


Solution for injection, pre-filled syringe


intravenous use




Finland







Bayer Schering Pharma Oy




Pansiontie 47,




20210 Turku




Finland






PRIMOVIST


0,25 mmol/ml


solution for injection


intravenous use




Finland







Bayer Schering Pharma Oy




Pansiontie 47,




20210 Turku




Finland






PRIMOVIST


0,25 mmol/ml


Solution for injection, pre-filled syringe


intravenous use




Finland







Bracco International B.V




Strawinskylaan 3051,




NL-1077 ZX Amsterdam




Netherlands






PROHANCE


279,3 mg/ml


solution for injection


intravenous use




Finland







Bayer Schering Pharma Oy




Pansiontie 47,




20210 Turku




Finland






GADOVIST


1 mmol/ml


solution for injection


intravenous use




Finland







Bayer Schering Pharma Oy




Pansiontie 47,




20210 Turku




Finland






GADOVIST


1 mmol/ml


Solution for injection (syringe)


intravenous use




Finland







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






DOTAREM


279,3 mg/ml


solution for injection


intravenous use




France







GE HEALTHCARE




11, avenue Morane Saulnier




78140 Vélizy Villacoublay




France






OMNISCAN 0,5 mmol/ml, solution injectable


28,7 g/1,0 ml


solution for injection


intravenous use




France







GE HEALTHCARE




11, avenue Morane Saulnier




78140 Vélizy Villacoublay




France






OMNISCAN 0,5 mmol/ml, solution injectable en seringue pré-remplie


287 mg/1 ml


Solution for injection (pre-filled syringe)


intravenous use




France







BRACCO IMAGING France




7, place Copernic




91080 Courcouronnes




France






MULTIHANCE 0,5 mmol/ml, solution injectable (IV)


529 mg/1 ml


solution for injection


intravenous use




France







BRACCO IMAGING France




7, place Copernic




91080 Courcouronnes




France






MULTIHANCE 0,5 mmol/ml, solution injectable en seringue pré-remplie


529 mg/1 ml


solution for injection


intravenous use




France







BAYER SANTE




220, avenue de la Recherche




59120 Loos




France






MAGNEVIST, solution injectable (IV)


46,901 g/1,0 ml


solution for injection


intravenous use




France







BAYER SANTE




220, avenue de la Recherche




59120 Loos




France






MAGNEVIST, solution injectable en seringue pré-remplie (IV)


46,901 g/1,0 ml


Solution for injection (pre-filled syringe)


intravenous use




France







BRACCO IMAGING France




7, place Copernic




91080 Courcouronnes




France






PROHANCE 1 396,5 mg/5 ml, solution injectable


1 396,50 mg/5 ml


solution for injection


intravenous use




France







BRACCO IMAGING France




7, place Copernic




91080 Courcouronnes




France






PROHANCE 1 396,5 mg/5 ml, solution injectable en seringue pré-remplie


1 396,5 mg/5ml


Solution for injection (pre-filled syringe)


intravenous use




France







BRACCO IMAGING France




7, place Copernic




91080 Courcouronnes




France






PROHANCE 2 793 mg/10 ml, solution injectable


2 793 mg/10 ml


solution for injection


intravenous use




France







BRACCO IMAGING France




7, place Copernic




91080 Courcouronnes




France






PROHANCE 2 793 mg/10 ml, solution injectable en seringue pré-remplie


2 793 mg/10 ml


Solution for injection (pre-filled syringe)


intravenous use




France







BRACCO IMAGING France




7, place Copernic




91080 Courcouronnes




France






PROHANCE 4 189,5 mg/15 ml, solution injectable


4 189,50 mg/15 ml


solution for injection


intravenous use




France







BRACCO IMAGING France




7, place Copernic




91080 Courcouronnes




France






PROHANCE 4 189,5 mg/15 ml, solution injectable en seringue pré-remplie


4 189,50 mg/15 ml


Solution for injection (pre-filled syringe)


intravenous use




France







BRACCO IMAGING France




7, place Copernic




91080 Courcouronnes




France






PROHANCE 4 748,10 mg/17 ml, solution injectable en seringue pré-remplie


4 748,1 mg/17 ml


Solution for injection (pre-filled syringe)


intravenous use




France







BRACCO IMAGING France




7, place Copernic




91080 Courcouronnes




France






PROHANCE 5 586 mg/20 ml, solution injectable


5 586 mg/20 ml


solution for injection


intravenous use




France







BAYER SANTE




220, avenue de la Recherche




59120 Loos




France






GADOVIST 1,0 mmol/mL, solution injectable


604,72 mg/1 ml


solution for injection


intravenous use




France







BAYER SANTE




220, avenue de la Recherche




59120 Loos




France






GADOVIST 1,0 mmol/mL, solution injectable en seringue préremplie


604,72 mg/1 ml


Solution for injection (pre-filled syringe)


intravenous use




France







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






DOTAREM 0,5 mmol/ml, solution injectable en flacon


27,932 g/1,0 ml


solution for injection


intravenous use




France







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






DOTAREM 0,5 mmol/ml, solution injectable en seringue pré-remplie


27,932 g/1,0 ml


Solution for injection (pre-filled syringe)


intravenous use




Greece







GE HEALTHCARE




PLAPOUTA 139 & LAMIAS ST




NEO IRAKLEIO 14121




GREECE






OMNISCAN


287 mg/ml


solution for injection


intravenous use




Greece







BAYER HELLAS ABEE




SOROU 18-20,




151 25 MAROUSI, ATHENS, GREECE






MAGNEVIST


469,01 mg/ml


solution for injection


intravenous use




Greece







GEROLYMATOS P.G.N. AEBE




ASKLIPIOU ST KRYONERI




ATTICA




GREECE






MULTIHANCE


529 mg/mlm


solution for injection


intravenous use




Greece







GEROLYMATOS P.G.N. AEBE




ASKLIPIOU ST KRYONERI




ATTICA




GREECE






MULTIHANCE


529 mg/mlm


Solution for injection prefilled syringe


intravenous use




Greece







BAYER HELLAS ABEE




SOROU 18-20,




151 25 MAROUSI, ATHENS,




GREECE






PRIMOVIST


0,25 mmol/ml


Solution for injection


intravenous use




Greece







BAYER HELLAS ABEE




SOROU 18-20,




151 25 MAROUSI, ATHENS,




GREECE






PRIMOVIST ‘PFS’


0,25 mmol/ml


Solution for injection prefilled syringe


intravenous use




Greece







BAYER HELLAS ABEE




SOROU 18-20,




151 25 MAROUSI, ATHENS,




GREECE






GADOVIST


1 mmol/ml


solution for injection


intravenous use




Greece







BAYER HELLAS ABEE




SOROU 18-20,




151 25 MAROUSI, ATHENS,




GREECE






GADOVIST PFS


1 mmol/ml


Solution for injection prefilled syringe


intravenous use




Greece







Hospital Line SA




K. Palama 36




GR-143 43, N. Chalkidona, Athens




Greece






Dotarem


1,4 mg/ml


solution for injection


intravenous use




Greece







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






VASOVIST


0,25 mmol/ml


solution for injection


intravenous use




Hungary







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






DOTAREM 0,5 mmol/ml injection 15ml


0,5 mmol/ml


injection


intravenous use




Hungary







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






DOTAREM 0,5 mmol/ml injection 20ml


0,5 mmol/ml


injection


intravenous use




Hungary







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






DOTAREM 0,5 mmol/ml injection 60ml


0,5 mmol/ml


injection


intravenous use




Hungary







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






DOTAREM 0,5 mmol/ml injection 1,0ml


0,5 mmol/ml


injection


intravenous use




Hungary







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






GADOVIST 1,0 mmol/ml solution for injection


1 mmol/ml


solution for injection


intravenous use




Hungary







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






GADOVIST


1 mmol/ml


solution for injection, prefilled syringe


intravenous use




Hungary







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






MAGNEVIST


0,5 mmol/ml


solution for injection


intravenous use




Hungary







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






MAGNEVIST


0,5 mmol/ml


injection in a pre-filled syringe


intravenous use




Hungary







Bracco S.p.A.




Via Emilio Folli, 50




20134 Milano




Italy






MULTIHANCE


0,5 M


solution for injection


intravenous use




Hungary







GE Healthcare AS




Nycoveien 1-2




4220 Nydalen,




Oslo N-0401




Norway






OMNISCAN 0,5 mmol/ml injection


0,5 mmol/ml


solution for injection


intravenous use




Hungary







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






PRIMOVIST


0,25 mmol/ml


solution for injection


intravenous use




Hungary







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






PRIMOVIST


0,25 mmol/ml


solution for injection, pre-filled syringe


intravenous use




Ireland







GE Healthcare AS




Nycoveien 1-2




4220 Nydalen,




Oslo N-0401




Norway






Omniscan 0,5 mmol/ml solution for injection, glass vial/bottle


0,5 mmol/ml


solution for injection


intravenous use




Ireland







GE Healthcare AS




Nycoveien 1-2




4220 Nydalen,




Oslo N-0401




Norway






Omniscan 0,5 mmol/ml solution for injection, polypropylene bottles


0,5 mmol/ml


solution for injection


intravenous use




Ireland







GE Healthcare AS




Nycoveien 1-2




4220 Nydalen,




Oslo N-0401




Norway






Omniscan 0,5 mmol/ml solution for injection, prefilled syringe


0,5 mmol/ml


solution for injection, prefilled syringe


intravenous use




Ireland







Bayer Limited




The Atrium




Blackthorn Road




Dublin 18




Ireland






Primovist 0,25 mmol/ml Sol for Injection


0,25 mmol/ml


solution for injection


intravenous use




Ireland







Bayer Limited




The Atrium




Blackthorn Road




Dublin 18




Ireland






Primovist 0,25 mmol/ml Sol for Injection, prefilled syringe


0,25 mmol/ml


solution for injection, prefilled syringe


intravenous use




Ireland







Bayer Limited




The Atrium




Blackthorn Road




Dublin 18




Ireland






Gadovist 1,0 mmol/ml Solution for Injection


1,0 mmol/ml


solution for injection


intravenous use




Ireland







Bayer Limited




The Atrium




Blackthorn Road




Dublin 18




Ireland






Gadovist 1,0 mmol/ml Solution for Injection in prefilled syringe


1,0 mmol/ml


solution for injection, in prefilled syringe


intravenous use




Ireland







Bayer Limited




The Atrium




Blackthorn Road




Dublin 18




Ireland






Gadovist 1,0 mmol/ml Solution for Injection in prefilled cartridge


1,0 mmol/ml


solution for injection, in prefilled cartridge


intravenous use




Ireland







Bracco International B.V




Strawinskylaan 3051




NL-1077 ZX Amsterdam




Netherlands






Prohance 279,3 mg/ml Solution for Injection, 5 ml vial


279,3 mg/ml


solution for injection


intravenous use




Ireland







Bracco International B.V




Strawinskylaan 3051




NL-1077 ZX Amsterdam




Netherlands






Prohance 279,3 mg/ml Solution for Injection, 10 ml vial


279,3 mg/ml


solution for injection


intravenous use




Ireland







Bracco International B.V




Strawinskylaan 3051




NL-1077 ZX Amsterdam




Netherlands






Prohance 279,3 mg/ml Solution for Injection, 15 ml vial


279,3 mg/ml


solution for injection


intravenous use




Ireland







Bracco International B.V




Strawinskylaan 3051




NL-1077 ZX Amsterdam




Netherlands






Prohance 279,3 mg/ml Solution for Injection, 20 ml vial


279,3 mg/ml


solution for injection


intravenous use




Ireland







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






Dotarem 279,32 mg/ml Solution for Injection, glass pre-filled syringes


279,32 mg/ml


solution for injection


intravenous use




Ireland







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






Dotarem 279,32 mg/ml Solution for Injection, glass vials


279,32 mg/ml


solution for injection


intravenous use




Ireland







Bracco SpA




Via Egidio Folli 50




I-20134 Milan




Italy






Multihance 0,5 M solution for injection


529 mg/ml


solution for injection


intravenous use




Ireland







Bracco SpA




Via Egidio Folli 50




I-20134 Milan




Italy






Multihance 529 mg/ml solution for injection in prefiled syringe


529 mg/ml


solution for injection in prefilled syringe


intravenous use




Ireland







Insights Agents GmbH




Ringstrasse 19B




D-69115 Heidelberg




Germany






Magnegita 500 micromol/ml solution for injection


500 mmol/ml


solution for injection


intravenous use




Ireland







Bayer Limited




The Atrium




Blackthorn Road




Dublin 18




Ireland






Magnevist 0,5 mmol/ml Solution for Injection


0,5 mmol/ml


solution for injection


intravenous use




Ireland







Bayer Limited




The Atrium




Blackthorn Road




Dublin 18




Ireland






Magnevist 0,5 mmol/ml Solution for Injection in pre-filled syringe.


0,5 mmol/ml


solution for Injection in pre-filled syringe


intravenous use




Iceland







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Magnevist


469 mg/ml


solution for injection


intravenous use




Iceland







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Magnevist


469 mg/ml


solution for injection, prefilled syringe


intravenous use




Iceland







GE Healthcare AS




Nycoveien 1-2




4220 Nydalen,




Oslo N-0401




Norway






Omniscan


0,5 mmol/ml


solution for injection


intravenous use




Iceland







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Gadovist


1,0 mmol/ml


Solution for injection


Intravenous use




Italy







Bayer Schering Pharma AG




Müllerstrasse 170-178,




DE-13342 Berlin-Wedding




Germany






Magnevist


469 mg/ml


solution for injection


intravenous use




Italy







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






Dotarem


0,5 mmol/ml


solution for injection


intravenous use




Italy







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






Dotarem


0,0025 mmol/ml


solution for injection


intravenous use




Italy







GE Healthcare




Via Galeno 36,




20126 Milano




Italy






Omniscan


287 mg/ml (0,5 mmol/ml)


solution for injection


intravenous use




Italy







Bracco Imaging Italia




Via Egidio Folli, 50




20134 Milano




Italy






ProHance


279,3 mg/ml (0,5 M)


solution for infusion


intravenous use




Italy







Bracco Imaging Italia




Via Egidio Folli, 50




20134 Milano




Italy






MultiHance


334 mg/ml (0,5 M)


solution for injection


intravenous use




Italy







Bayer SpA




Viale Certosa, 130




20156 Milano




Italy






Gadovist


604,72 mg/ml


solution for injection


intravenous use




Italy







Bayer SpA




Viale Certosa, 130




20156 Milano




Italy






Primovist


0,25 mmol/ml


solution for injection


intravenous use




Lithuania







Bayer Schering Pharma AG




Müllerstrasse 178




DE-13353 Berlin




Germany






Gadovist


1 mmol/ml


solution for injection (pre- filled syringe)


intravenous use




Lithuania







Bayer Schering Pharma AG




Müllerstrasse 178




DE-13353 Berlin




Germany






Primovist


0,25 mmol/ml


solution for injection


intravenous use




Lithuania







Bayer Schering Pharma AG




Müllerstrasse 178




DE-13353 Berlin




Germany






Primovist


0,25 mmol/ml


solution for injection (pre-filled syringe)


intravenous use




Lithuania







Bayer Schering Pharma AG




Müllerstrasse 178




DE-13353 Berlin




Germany






Magnevist


0,5 mmol/ml


solution for injection/infusion


intravenous use




Lithuania







Insight Agents GmbH




Ringstr. 19 B




D-69115 Heidelberg




Germany






Magnegita


500 micromol/ml


solution for injection


intravenous use




Lithuania







GE Healthcare AS




Nycoveien 1-2




P.O. Box 4220 Nydalen,




Oslo N-0401




Norway






Omniscan


0,5 mmol/ml


solution for injection


intravenous use




Luxembourg







Codali S.A.




Avenue Henri Dunant 31




1140 Bruxelles




Belgium






DOTAREM


37,7 G


solution for injection


intravenous use




Luxembourg







Insight Agents GmbH




Ringstr. 19 B




D-69115 Heidelberg




Germany






GADOPENTETATE INSIGHT


469 MG/ML


solution for injection


intravenous use




Luxembourg







Bayer SA-NV




J.E. Mommaertslaan 14




1831 Diegem




Belgium






GADOVIST 1


604,72 mg


solution for injection


intravenous use




Luxembourg







Bayer SA-NV




J.E. Mommaertslaan 14




1831 Diegem




Belgium






GADOVIST PFS-1


604,72 mg/1 ml


solution for injection


intravenous use




Luxembourg







Insight Agents GmbH




Ringstr. 19 B




D-69115 Heidelberg




Germany






MAGNEGITA


78,63 MG/1 ML


solution for injection


intravenous use




Luxembourg







Bayer SA-NV




J.E. Mommaertslaan 14




1831 Diegem




Belgium






MAGNEVIST


4,69 G/10 ML


solution for injection


intravenous use




Luxembourg







Bracco IMAGING Deutschland GmbH




Max-Stromeyer-Str. 116




D-78467 Konstanz




Germany






MULTIHANCE


529 mg/1 ml


solution for injection


intravenous use




Luxembourg







GE HEALTHCARE BVBA




Kouterveldstraat 20




1831 DIEGEM




Belgium






OMNISCAN


287 MG/1 ML


solution for injection


intravenous use




Luxembourg







Bracco IMAGING Deutschland GmbH




Max-Stromeyer-Str. 116




D-78467 Konstanz




Germany






PROHANCE


279,3 MG/1 ML


solution for injection


intravenous use




Latvia







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Gadovist 1,0 mmol/ml solution for injections


1,0 mmol/ml


solution for injection


intravenous use




Latvia







Insight Agents GmbH




Ringstr. 19 B




D-69115 Heidelberg




Germany






Magnegita 500 micromol/ml solution for injection


500 micromol/ml


solution for injection


intravenous use




Latvia







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Magnevist 0,5 mmol/ml solution for injection


0,5 mmol/ml


solution for injection


intravenous use




Latvia







GE Healthcare AS




Nycoveien 1-2, 4220 Nydalen,




Oslo N-0401




Norway






Omniscan 0,5 mmmol/ml solution for injection


0,5 mmol/ml


solution for injection


intravenous use




Latvia







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Primovist 0,25 mmol/ ml solution for injection


0,25 mmol/ml


solution for injection


intravenous use




Latvia







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Primovist 0,25 mmol/ml solution for injection pre-filled syringe


0,25 mmol/ml


Solution for injection, pre-filled syringe


intravenous use




Malta







GE Healthcare AS




Nycoveien 1-2, 4220 Nydalen,




Oslo N-0401




Norway






Omniscan


0,5 mMol/ml (287 mg equiv. 0,5 mmol)


solution for injection


intravenous use




Malta







Bayer plc




Bayer House, Strawberry Hill,




Newbury, Berkshire, RG14 1JA




UK






Magnevist


469,01 mg


Solution for injection


intravenous use




Malta







Bayer plc




Bayer House, Strawberry Hill,




Newbury, Berkshire, RG14 1JA




UK






Primovist


PFS 0,25 mmol/ml


Solution for injection, prefilled syringe


intravenous use




Netherlands







Guerbet Nederland B.V.




Avelingen-West 3A




4202 MS GORINCHEM




Netherlands






Dotarem


0,5 mmol/ml


solution for injection


intravenous use




Netherlands







Bayer B.V.




Energieweg 1




3641 RT MIJDRECHT




Netherlands






Gadovisit


1,0 mmol/ml


solution for injection


intravenous use




Netherlands







Bayer B.V.




Energieweg 1




3641 RT MIJDRECHT




Netherlands






Magnevist


0,5 mmol/ml


solution for injection


intravenous use




Netherlands







Bracco IMAGING Deutschland GmbH




Max-Stromeyer-Str. 116




D-78467 Konstanz




Germany






Multihance


0,5 mmol/ml


solution for injection


intravenous use




Netherlands







GE Healthcare B.V.




Cygne Centre De Rondom 8




5612 AP EINDHOVEN




Netherlands






Omniscan


0,5 mmol/ml


solution for injection


intravenous use




Netherlands







Bayer B.V.




Energieweg 1




3641 RT MIJDRECHT




Netherlands






Primovist


0,25 mmol/ml


solution for injection


intravenous use




Netherlands







Bracco IMAGING Deutschland GmbH




Max-Stromeyer-Str. 116




D-78467 Konstanz




Germany






Prohance


0,5 mmol/ml


solution for injection


intravenous use




Netherlands







Insight Agents GmbH




Ringstr. 19 B




D-69115 Heidelberg




Germany






Magnegita


0,5 mmol/ml


solution for injection


intravenous use




Netherlands







Insight Agents GmbH




Ringstr. 19 B




D-69115 Heidelberg




Germany






Gadopentetate Insight


0,5 mmol/ml


solution for injection


intravenous use




Norway







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






Dotarem


279,3 mg/ml


solution for injection


intravenous use




Norway







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Magnevist


469 mg/ml


solution for injection


intravenous use




Norway







Bracco S.p.A.




Via Emilio Folli, 50




20134 Milano




Italy






MultiHance


334 mg/ml


solution for injection


intravenous use




Norway







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Primovist


0,25 mmol/ml


solution for injection


intravenous use




Norway







Bracco International B.V




Strawinskylaan 3051




NL-1077 ZX Amsterdam




Netherlands






Prohance


279,3 mg/ml


solution for injection


intravenous use




Norway







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Gadovist


1 mmol/ml


solution for injection


intravenous use




Norway







GE Healthcare AS




Nycoveien 1-2




4220 Nydalen,




Oslo N-0401




Norway






Omniscan


0,5 mmol/ml


solution for injection


intravenous use




Poland







GE Healthcare AS




Nycoveien 1-2




P.O. Box 4220 Nydalen,




Oslo NO-0401




Norway






Omniscan


0,5 mmol/ml


solution for injection


intravenous use




Poland







Bracco Imaging Deutschland GmbH




Max-Stromeyer-Str. 116




D-78467 Konstanz




Germany






ProHance


279,3 mg/ml


solution for injection


intravenous use




Poland







Bayer Schering Pharma AG




D-13342 Berlin




Germany






Gadovist 1,0


604,72 mg/ml


solution for injection


intravenous use




Poland







Bayer Schering Pharma AG




D-13342 Berlin




Germany






Magnevist


469 mg/ml


solution for injection


intravenous use




Poland







Bracco ALTANA Pharma GmbH




Max-Stromeyer-Str. 116




78467 Konstanz




Germany






Multihance


529 mg/ml


solution for injection


intravenous use




Poland







Bayer Schering Pharma AG




D-13342 Berlin




Germany






Primovist


0,25 mmol/ml


solution for injection


intravenous use




Portugal







Bayer Portugal S.A.




Rua Quinta do Pinheiro, 5




2794-003 Carnaxide




Portugal






Primovist


0,25 mmol/ml


solution for injection


intravenous use




Portugal







Bayer Portugal S.A.




Rua Quinta Pinheiro, 5,




2794-003 Carnaxide




Portugal






Primovist


0,25 mmol/ml


solution for injection (pre-filled syringe)


intravenous use




Portugal







Lusal - Produção Químico-Farmacêutica Luso-Alemã Lda.




Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide




Portugal






Gadovist


1 mmol/ml


solution for injection


intravenous use




Portugal







Lusal - Produção Químico-Farmacêutica Luso-Alemã Lda.




Rua Quinta Pinheiro, 5, Outurela 2794-003 Carnaxide




Portugal






Gadovist


1 mmol/ml


solution for injection (pre-filled syringe)


intravenous use




Portugal







A. Martins & Fernandes S.A.




Rua Raúl Mesnier du Ponsard,




4 B 1750-243 Lisboa




Portugal






Dotarem


377 mg/ml


solution for injection


intravenous use




Portugal







Satis-Radioisótopos e Protecções Contra Sobretensões Eléctricas Unipessoal Lda.




Edifício Ramazzotti, Av. do Forte,




n.o 6 - 6A, 2790-502 Carnaxide




Portugal






Omniscan


287 mg/ml


solution for injection


intravenous use




Romania







Bracco S.p.A.




Via Egidio Folli, 50




20134 Milano




Italy






MULTIHANCE 0,5M


0,529 g (0,334 g + 0,195 g )/ml


solution for injection


intravenous use




Romania







Bayer Schering Pharma AG




Müllerstrasse 178




DE-13342 Berlin-




Germany






MAGNEVIST


469,01 mg/ml


solution for injection


intravenous use




Romania







INSIGHT AGENTS GmbH




Ringstrasse. 19B




69115 Heidelberg




Germany






MAGNEGITA 500 micromol/ml, soluție injectabilă


500 micromol/ml (469,01 mg/ml)


solution for injection


intravenous use




Romania







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






DOTAREM 0,5 mmol/ml soluție injectabilă în seringă preumplută


27,932 g/ml


solution for injection, pre-filled syringe


intravenous use




Romania







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






DOTAREM 0,5 mmol/ml soluție injectabilă unidoză


27,932 g/ml


solution for injection


intravenous use




Romania







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






DOTAREM 0,5 mmol/ml soluție injectabilă multidoză


27,932 g/ml


solution for injection


intravenous use




Romania







Bayer Schering Pharma AG




Müllerstrasse 178




DE-13342 Berlin-




Germany






PRIMOVIST 0,25 mmol/ml, soluție injectabilă în seringă preumplută


181,430 mg/ml


solution for injection, pre-filled syringe


intravenous use




Romania







Bayer Schering Pharma AG




Müllerstrasse 178




DE-13342 Berlin-




Germany






GADOVIST 1,0 mmol/ml, soluție injectabilă


604,720 mg/ml


solution for injection


intravenous use




Romania







GE Healthcare AS




Nycoveien 1-2




P.O. Box 4220 Nydalen,




N-0401 Oslo




Norway






OMNISCAN, soluție injectabilă


287,000 mg/ml


solution for injection


intravenous use




Sweden







Bayer Schering Pharma AG




Müllerstrasse 178




DE-13342 Berlin-Wedding




Germany






Magnevist


0,5 mmol/m


solution for injection


intravenous use




Sweden







Bracco SpA




Via Egidio Folli 50




I-20134 Milan




Italy






Multihance


334 mg/ml


solution for injection


intravenous use




Sweden







Bracco SpA




Via Egidio. Folli 50




I-20134 Milan




Italy






Multihance


334 mg/ml


solution for injection, pre-filled syringe


intravenous use




Sweden







Bracco International BV




Stravinskylaan 3051




NL-1077 ZX Amsterdam




The Netherlands






Prohance


279,3 mg/ml


solution for injection


intravenous use




Sweden







GE Healthcare AS




P.O.Box 4220




Nydalen




N-0401 Oslo




Norway






Omniscan


0,5 mmol/ml


solution for injection


intravenous use




Sweden







GE Healthcare AS




P.O.Box 4220




Nydalen




N-0401 Oslo




Norway






Omniscan


0,5 mmol/ml


solution for injection, pre-filled syringe


intravenous use




Sweden







Bayer Schering Pharma AG,




Müllerstrasse 178




DE-133 42 Berlin




Germany






Primovist


0,25 mmol/ml


solution for injection


intravenous use




Sweden







Bayer Schering Pharma AG,




Müllerstrasse 178




DE-133 42 Berlin




Germany






Primovist


0,25 mmol/ml


solution for injection, pre-filled syringe


intravenous use




Sweden







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






Dotarem


279,3 mg/ml


solution for injection


intravenous use




Sweden







Bayer Schering Pharma AG




Müllerstrasse 178,




DE-13342 Berlin-Wedding




Germany






Gadovist


1,0 mmol/ml


solution for injection


intravenous use




Sweden







Bayer Schering Pharma AG




Müllerstrasse 178,




DE-13342 Berlin-Wedding




Germany






Gadovist


1,0 mmol/ml


solution for injection, pre-filled syringe


intravenous use




Sweden







Insight Agents GmbH




Ringstr.19 B




D-69115 Heidelberg




Germany






Magnegita


500 mikromol/ml


solution for injection


intravenous use




Sweden







Insight Agents GmbH




Ringstr.19 B




D-69115 Heidelberg




Germany






Gadopentetsyrad imegluminat Insight


500 mikromol/ml


solution for injection


intravenous use




Sweden







Bayer Schering Pharma AG




Müllerstrasse 178




DE-13342 Berlin-Wedding




Germany






Magnograf


0,5 mmol/ml


solution for injection


intravenous use




Sweden







Bayer Schering Pharma AG




Müllerstrasse 178




DE-13342 Berlin-Wedding




Germany






Magnograf


0,5 mmol/ml


solution for injection pre-filled syringe


intravenous use




Slovenia







Higieia d.o.o.




Zastopstva in trgovina, Blatnica 10,




1236 Trzin,




Slovenia






Omniscan 0,5 mmol/ml raztopina za injiciranje


0,5 mmol/ml


solution for injection


intravenous use




Slovenia







Insight Agents GmbH




Ringstr. 19 B




D-69115 Heidelberg




Germany






Magnetita 500 mikromolov/ml raztopina za injiciranje


500 micromol/ml


solution for injection


intravenous use




Slovenia







Bayer Schering Pharma AG




Müllerstrasse 170-178




DE-13342 Berlin-Wedding




Germany






Magnevist


0,5 mmol/ml


solution for injection


intravenous use




Slovenia







Auremiana




izvozno uvozno trgovsko podjetje, d.o.o., Sežana, Partizanska 109, 6210 Sežana






Multihance 0,5 mmol/ml raztopina za injiciranje


334 mg/ml


solution for injection


intravenous use




Slovenia







Emporio Medical




d.o.o., Prešernova 5, 1,00 Ljubljana,




Slovenia






Dotarem 0,5 mmol/ml raztopina za injiciranje


27,93 g/ml


solution for injection


intravenous use




Slovenia







Bayer Schering Pharma AG




Müllerstrasse 170-178, DE-13342




Berlin-Wedding




Germany






Gadovist 1,0 mmol/ml raztopina za injiciranje


1,0 mmol/ml


solution for injection


intravenous use




Slovenia







Bayer Schering Pharma AG




Müllerstrasse 170-178, DE-13342




Berlin-Wedding




Germany






Primovist 0,25 mmol/ml raztopina za injiciranje v napolnjeni injekcijski brizgi


0,25 mmol/ml


solution for injection


intravenous use




Slovakia







Bayer Schering Pharma AG




Müllerstrasse 170-178, DE-13342




Berlin-Wedding




Germany






Gadovist 1,0 mmol/ml


604,72 mg/ml


solution for injection


intravenous use




Slovakia







GE Healthcare AS




Nycoveien 1-2, 4220 Nydalen,




Oslo N-0401




Norway






OMNISCAN


0,5 mmol/ml


solution for injection


intravenous use




Slovakia







Bayer Schering Pharma AG




Müllerstrasse 170-178, DE-13342




Berlin-Wedding




Germany






Primovist 0,25 mmol/ml, injekčný roztok


0,25 mmol/ml


solution for injection


intravenous use




Slovakia







Bracco IMAGING Deutschland GmbH




Max-Stromexer-Str. 116




D-78467 Konstanz




Germany






PROHANCE


279,3 mg/ml


solution for injection


intravenous use




Slovakia







Bayer Schering Pharma AG




Müllerstrasse 170-178,




DE-13342 Berlin-Wedding




Germany






Magnevist


469 mg/ml


solution for injection


intravenous use




United Kingdom







GE Healthcare AS




Nycoveien 1-2, 4220 Nydalen,




Oslo N-0401




Norway






Omniscan injection


0,5 mmol/ml and 0,5 mmol/litre


solution for injection


intravenous use




United Kingdom







Bayer plc




Bayer House, Strawberry Hill,




Newbury, Berkshire, RG14 1JA




UK






Magnevist


0,5 mmol/ml


solution for injection


intravenous use




United Kingdom







Bracco S.p.A.




Via Emilio Folli, 50




20134 Milano




Italy






Multihance


0,5 M/ml


solution for injection


intravenous use




United Kingdom







Bayer plc




Bayer House, Strawberry Hill,




Newbury, Berkshire, RG14 1JA




UK






Primovist solution for injection


0,25 mmol/ml


solution for injection


intravenous use




United Kingdom







Bracco International B.V.,




Strawinskylaan 3051




Amsterdam 107 zx




Netherlands






Prohance


0,5 M/ml


solution for injection


intravenous use




United Kingdom







Bayer plc




Bayer House, Strawberry Hill, Newbury,




Berkshire, RG14 1JA




UK






Gadovist


1,0 mmol/ml


solution for injection


intravenous use




United Kingdom







GUERBET




BP 57400




95943 Roissy Charles de Gaulle Cedex




France






Dotarem solution for injection


0,5 mmol/ml


solution for injection


intravenous use







ANNEX VI

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State EU/EEA


Marketing Authorisation Holder


(Invented) name


Strength


Pharmaceutical Form


Route of administration




Austria







GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,




A-1140 Wien,




Austria






Valtrex 1 000 mg - Filmtabletten


1 000 mg


film – coated tablet


Oral use




Austria







Sandoz GmbH




Biochemiestraße 10,




6250 Kundl




Austria






Valaciclovir Sandoz 1 000 mg - Filmtabletten


1 000 mg


film – coated tablet


Oral use




Austria







GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,




A-1140 Wien




Austria






Valtrex 500 mg - Filmtabletten


500 mg


film – coated tablet


Oral use




Austria







Sandoz GmbH




Biochemiestraße 10,




6250 Kundl




Austria






Valaciclovir Sandoz 500 mg - Filmtabletten


500 mg


film – coated tablet


Oral use




Austria







GlaxoSmithKline Pharma GmbH, Albert Schweitzer-Gasse 6,




A-1140 Wien,




Austria






Valtrex 250 mg - Filmtabletten


250 mg


film – coated tablet


Oral use




Austria







Sandoz GmbH




Biochemiestraße 10,




6250 Kundl




Austria






Valaciclovir Sandoz 250 mg - Filmtabletten


250 mg


film – coated tablet


Oral use




Belgium


GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Belgium


Zelitrex


500 mg


film – coated tablet


Oral use




Belgium


GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Belgium


Zelitrex


250 mg


film – coated tablet


Oral use




Bulgaria







Glaxo Group Ltd




Greenford Road




Greenford




Middlesex UB6 0NN




United Kingdom






Valtrex


500 mg


film – coated tablet


Oral use




Cyprus







Glaxo Group Limited




Berkeley Avenue




Greenford




Middlesex, UB6 0NN,




United Kingdom






Valtrex


500 mg


film – coated tablet


Oral use




Czech Republic







The Wellcome Foundation Ltd., Glaxo Wellcome House




Berkeley Avenue




Greenford




Middlesex




UB6 0NN,




United Kingdom






Valtrex 500 mg


500 mg


film – coated tablet


Oral use




Denmark







GlaxoSmithKline Pharma A/S, Nykaer 68




2605 Broendby,




Denmark






Zelitrex


1 000 mg


film – coated tablet


Oral use




Denmark







GlaxoSmithKline Pharma A/S, Nykaer 68




2605 Broendby,




Denmark






Zelitrex


500 mg


film – coated tablet


Oral use




Denmark







GlaxoSmithKline Pharma A/S, Nykaer 68




2605 Broendby,




Denmark






Zelitrex


250 mg


film – coated tablet


Oral use




Estonia







Glaxo Wellcome Operations




Glaxo Wellcome House,




Berkeley Avenue, Greenford,




Middlesex UB6 0NN,




United Kingdom






Valtrex


500 mg


film – coated tablet


Oral use




Finland







The Wellcome Foundation Ltd. Greenford,




Middlesex,




United Kingdom






Valtrex


500 mg


film – coated tablet


Oral use




Finland







Orion Corporation




Orionintie 1




FI-02200 Espoo,




Finland






Valavir


500 mg


film – coated tablet


Oral use




Finland







GlaxoSmithKline Oy




Piispansilta 9 A,




02230 Espoo,




Finland






Valtrex


250 mg


film – coated tablet


Oral use




France







Laboratoire GlaxoSmithKline




100 route de Versailles




78163 Marly-le-Roi cedex, France






Zelitrex 500 mg, comprimé enrobé


500 mg


film – coated tablet


Oral use




France







Laboratoire GlaxoSmithKline




100 route de Versailles




78163 Marly-le-Roi cedex, France






Zelitrex 1 000 mg, comprimé enrobé


1 000 mg


film – coated tablet


Oral use




France







Laboratoires BIOGARAN 15, boulevard Charles de Gaulle




92707 COLOMBES Cedex




France






Valaciclovir Biogaran 500 mg, comprimé enrobé


500 mg


film – coated tablet


Oral use




France







Laboratoire GlaxoSmithKline




100 route de Versailles




78163 Marly-le-Roi cedex, France






Valaciclovir GSK 500 mg, comprimé enrobé


500 mg


film – coated tablet


Oral use




France







sanofi-aventis France




1 – 13 boulevard Romain Rolland




75014 PARIS




France






Valaciclovir Winthrop 500 mg, comprimé enrobé


500 mg


film – coated tablet


Oral use




Germany







GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11,




80339 München,




Germany






Valtrex


500 mg


film – coated tablet


Oral use




Germany







GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11,




80339 München,




Germany






Valtrex S


500 mg


film – coated tablet


Oral use




Germany







GlaxoSmithKline GmbH & Co. KG, Theresienhöhe 11,




80339 München,




Germany






Valtrex S 250 mg


250 mg


film – coated tablet


Oral use




Greece







GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,




152 32 Halandri, Athens,




Greece






Valtrex


1 000 mg


film – coated tablet


Oral use




Greece







GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,




152 32 Halandri, Athens,




Greece






Valtrex


500 mg


film – coated tablet


Oral use




Greece







GlaxoSmithKline a.e.b.e, Leof. Kifissias 266,




152 32 Halandri, Athens,




Greece






Valtrex


250 mg


film – coated tablet


Oral use




Iceland







GlaxoSmithKline ehf.




Þverholt 14




105 Reykjavík,




Iceland






Valtrex


500 mg


film – coated tablet


Oral use




Iceland







GlaxoSmithKline ehf.




Þverholt 14




105 Reykjavík,




Iceland






Valtrex


250 mg


film – coated tablet


Oral use




Ireland


GlaxoSmithKline (Ireland) Ltd., Stonemasons Way, Rathfarnham, Dublin 16, Ireland


Valtrex 500 mg Film-coated Tablet


500 mg


film – coated tablet


Oral use




Ireland


GlaxoSmithKline (Ireland) Ltd., Stonemasons Way, Rathfarnham, Dublin 16, Ireland


Valtrex 250 mg Film-coated Tablet


250 mg


film – coated tablet


Oral use




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona,




Italy






Zelitrex


1 000 mg


film – coated tablet


Oral use




Italy







Sigma Tau Industrie Farmaceutiche Riunite S.p.A




Viale Shakespeare, 47 – 00144 Roma,




Italy






Talavir


1 000 mg


film – coated tablet


Oral use




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona,




Italy






Zelitrex


500 mg


film – coated tablet


Oral use




Italy







Sigma Tau Industrie Farmaceutiche Riunite S.p.A




Viale Shakespeare, 47 – 00144 Roma,




Italy






Talavir


500 mg


film – coated tablet


Oral use




Italy







GlaxoSmithKline S.p.A. - Via A. Fleming, 2 –




37135 Verona,




Italy






Zelitrex


250 mg


film – coated tablet


Oral use




Italy







Sigma Tau Industrie Farmaceutiche Riunite S.p.A




Viale Shakespeare, 47 – 00144 Roma,




Italy






Talavir


250 mg


film – coated tablet


Oral use




Latvia







GlaxoSmithKline Latvia SIA, Bruņinieku iela 5,




Riga, LV-1001




Latria






Valtrex 500 mg film-coated tablets


500 mg


film – coated tablet


Oral use




Lithuania







The Wellcome Foundation Ltd,




Glaxo Wellcome House, Berkeley Avenue,




Greenford,




Middlesex UB6 0NN,




United Kingdom






Valtrex


500 mg


film – coated tablet


Oral use




Luxembourg


GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Belgium


Zelitrex


500 mg


film – coated tablet


Oral use




Luxembourg


GlaxoSmithKline s.a. /n.v., rue du Tilleul 13, B-1332 Genval, Belgium


Zelitrex


250 mg


film – coated tablet


Oral use




Malta







The Wellcome Foundation Limited Glaxo Wellcome House, Berkeley Avenue, Greenford,




Middlesex, UB6 ONN,




United Kingdom






Valtrex


500 mg


film – coated tablet


Oral use




Netherlands







GlaxoSmithKline BV




Huis ter Heideweg 62




3705 LZ Zeist,




Netherlands






Zelitrex 500 mg


500 mg


film – coated tablet


Oral use




Netherlands







GlaxoSmithKline BV




Huis ter Heideweg 62




3705 LZ Zeist,




Netherlands






Zelitrex 250 mg


250 mg


film – coated tablet


Oral use




Norway







GlaxoSmithKline AS




Forskningsveien 2A




Postboks 180 Vinderen




0319 Oslo,




Norway






Valtrex


1 000 mg


film – coated tablet


Oral use




Norway







GlaxoSmithKline AS




Forskningsveien 2A




Postboks 180 Vinderen




0319 Oslo,




Norway






Valtrex


500 mg


film – coated tablet


Oral use




Norway







GlaxoSmithKline AS




Forskningsveien 2A




Postboks 180 Vinderen




0319 Oslo,




Norway






Valtrex


250 mg


film – coated tablet


Oral use




Poland







GlaxoSmithKline Export Ltd, 980 Great West Road, Brentford, Middlesex,




TW8 9GS




United Kingdom






Valtrex


500 mg


film – coated tablet


Oral use




Portugal







Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3




Arquiparque - Miraflores




1495-131 Algés




Portugal






Valtrex


1 000 mg


film – coated tablet


Oral use




Portugal







Alter, SAEstrada Marco do Grilo




Zemouto - Coina




2830 Barreiro




Portugal






Valavir


1 000 mg


film – coated tablet


Oral use




Portugal







Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3




Arquiparque - Miraflores




1495-131 Algés




Portugal






Valtrex


500 mg


film – coated tablet


Oral use




Portugal







Alter, SAEstrada Marco do Grilo




Zemouto - Coina




2830 Barreiro




Portugal






Valavir


500 mg


film – coated tablet


Oral use




Portugal







Laboratórios Wellcome de Portugal, Lda, Rua Dr António Loureiro Borges, no3




Arquiparque - Miraflores




1495-131 Algés




Portugal






Valtrex


250 mg


film – coated tablet


Oral use




Portugal







Alter, SAEstrada Marco do Grilo




Zemouto - Coina




2830 Barreiro




Portugal






Valavir


250 mg


film – coated tablet


Oral use




Romania







The Wellcome Foundation Limited, Glaxo Wellcome House, Berkeley Avenue,




Greenford,




Middlesex UB6 0NN,




United Kingdom






Valtrex


500 mg


film – coated tablet


Oral use




Slovak Republic







GlaxoSmithKline Slovakia s.r.o.,




Galvaniho 7/A,




82104 Bratislava




Slovak Republic






Valtrex


500 mg


film – coated tablet


Oral use




Slovenia







GSK do.o., Ljubljana




Knezov štradon 90




1001 Ljubljana




Slovenija






Valtrex


500 mg


film – coated tablet


Oral use




Spain







GlaxoSmithKline, S.A




Severo Ochoa, 2, 28760,




Tres Cantos Madrid




Spain






Valtrex


1 000 mg


film – coated tablet


Oral use




Spain







GlaxoSmithKline, S.A




Severo Ochoa, 2, 28760,




Tres Cantos Madrid




Spain






Virval


1 000 mg


film – coated tablet


Oral use




Spain







Allen Farmacéutica S.A.




Severo Ochoa, 2, 28760,




Tres Cantos Madrid




Spain






Valaciclovir Allen


1 000 mg


film – coated tablet


Oral use




Spain







Smithkline Beecham Farma S.A.




Severo Ochoa, 2, 28760,




Tres Cantos Madrid




Spain






Valherpes


1 000 mg


film – coated tablet


Oral use




Spain







GlaxoSmithKline, S.A




Severo Ochoa, 2, 28760,




Tres Cantos Madrid




Spain






Valtrex


500 mg


film – coated tablet


Oral use




Spain







GlaxoSmithKline, S.A Severo Ochoa, 2, 28760,




Tres Cantos Madrid




Spain






Virval


500 mg


film – coated tablet


Oral use




Spain







Allen Farmacéutica S.A.




Severo Ochoa, 2, 28760,




Tres Cantos Madrid




Spain






Valaciclovir Allen


500 mg


film – coated tablet


Oral use




Spain







Smithkline Beecham Farma S.A.




Severo Ochoa, 2, 28760,




Tres Cantos Madrid




Spain






Valherpes


500 mg


film – coated tablet


Oral use




Sweden







GlaxoSmithKline AB




Box 516




169 29 Solna,




Sweden






Valtrex


1 g


film – coated tablet


Oral use




Sweden







GlaxoSmithKline AB




Box 516




169 29 Solna,




Sweden






Valtrex


500 mg


film – coated tablet


Oral use




Sweden







GlaxoSmithKline AB




Box 516




169 29 Solna,




Sweden






Valtrex


250 mg


film – coated tablet


Oral use




United Kingdom







The Wellcome Foundation Ltd




Glaxo Wellcome House




Berkeley Avenue




Greenford




Middlesex




UB6 0NN,




United Kingdom




Trading as;





GlaxoSmithKline UK




Stockley Park West




Uxbridge




Middlesex




UB11 1BT




United Kingdom






Valtrex


500 mg


film – coated tablet


Oral use




United Kingdom







The Wellcome Foundation Ltd




Glaxo Wellcome House




Berkeley Avenue




Greenford




Middlesex




UB6 0NN,




United Kingdom




Trading as;





GlaxoSmithKline UK




Stockley Park West




Uxbridge




Middlesex




UB11 1BT




United Kingdom






Valtrex


250 mg


film – coated tablet


Oral use







ANNEX VII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State EU/EEA


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical Form


Route of administration




Austria







Novartis Pharma GmbH




Brunner Strasse 59




1235 Wien




Austria






Famvir 125 mg – Filmtabletten


125 mg


Film-coated tablets


Oral use




Austria







Novartis Pharma GmbH




Brunner Strasse 59




1235 Wien




Austria






Famvir 250 mg – Filmtabletten


250 mg


Film-coated tablets


Oral use




Austria







Novartis Pharma GmbH




Brunner Strasse 59




1235 Wien




Austria






Famvir 500 mg – Filmtabletten


500 mg


Film-coated tablets


Oral use




Cyprus







Demetriades & Papaellinas Ltd




21 Kasou P.O. Box 23490




Nicosia




Cyprus






Famvir


125 mg


Film-coated tablets


Oral use




Cyprus







Demetriades & Papaellinas Ltd




21 Kasou P.O. Box 23490




Nicosia




Cyprus






Famvir


250 mg


Film-coated tablets


Oral use




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




2100 Kopenhagen Ø




Denmark






Famvir


125 mg


Film-coated tablets


Oral use




Denmark







Novartis Healthcare A/S




Lyngbyvej 172




2100 Kopenhagen Ø




Denmark






Famvir


500 mg


Film-coated tablets


Oral use




Finland







Novartis Finland Oy




Metsänneidonkuja 10




FI-02130 Espoo




Finland






Famvir


125 mg


Film-coated tablets


Oral use




Finland







Novartis Finland Oy




Metsänneidonkuja 10




FI-02130 Espoo




Finland






Famvir


250 mg


Film-coated tablets


Oral use




Finland







Novartis Finland Oy




Metsänneidonkuja 10




FI-02130 Espoo




Finland






Famvir


500 mg


Film-coated tablets


Oral use




France







Novartis Pharma S.A.S.




2 - 4, rue Lionel Terray




92500 Rueil-Malmaison




France






Oravir


125 mg


Film-coated tablets


Oral use




France







Novartis Pharma S.A.S.




2 - 4, rue Lionel Terray




92500 Rueil-Malmaison




France






Oravir


500 mg


Film-coated tablets


Oral use




Germany







Novartis Pharma GmbH




Roonstrasse 25




90429 Nürnberg




Germany






Famvir 125 mg Filmtabletten


125 mg


Film-coated tablets


Oral use




Germany







Novartis Pharma GmbH




Roonstrasse 25




90429 Nürnberg




Germany






Famvir 250 mg Filmtabletten


250 mg


Film-coated tablets


Oral use




Germany







Novartis Pharma GmbH




Roonstrasse 25




90429 Nürnberg




Germany






Famvir Zoster 250 mg Filmtabletten


250 mg


Film-coated tablets


Oral use




Germany







Grünwalder Gesundheitsprodukte GmbH




Ruhlandstr. 5




83646 Bad Tölz




Germany






Famciclovir-Sandoz 250 mg Filmtabletten


250 mg


Film-coated tablets


Oral use




Germany







Grünwalder Gesundheitsprodukte GmbH




Ruhlandstr. 5




83646 Bad Tölz




Germany






Famciclovir-Sandoz 500 mg Filmtabletten


500 mg


Film-coated tablets


Oral use




Germany







Grünwalder Gesundheitsprodukte GmbH




Ruhlandstr. 5




83646 Bad Tölz




Germany






Famciclovir-SB 250 mg Filmtabletten


250 mg


Film-coated tablets


Oral use




Germany







Grünwalder Gesundheitsprodukte GmbH




Ruhlandstr. 5




83646 Bad Tölz




Germany






Famciclovir-SB Zoster 250 mg Filmtabletten


250 mg


Film-coated tablets


Oral use




Greece







Novartis (Hellas) S.A.C.I.




12th Km National Road No. 1




GR-144 51 Metamorphosis




Greece






Famvir


125 mg


Film-coated tablets


Oral use




Greece







Novartis (Hellas) S.A.C.I.




12th Km National Road No. 1




GR-144 51 Metamorphosis




Greece






Famvir


250 mg


Film-coated tablets


Oral use




Greece







Novartis (Hellas) S.A.C.I.




12th Km National Road No. 1




GR-144 51 Metamorphosis




Greece






Famvir


500 mg


Film-coated tablets


Oral use




Hungary







Novartis Hungaria Kft.




Bartók Béla út 43-47




H-1114 Budapest




Hungary






Famvir


125 mg


Film-coated tablets


Oral use




Hungary







Novartis Hungaria Kft.




Bartók Béla út 43-47




H-1114 Budapest




Hungary






Famvir


250 mg


Film-coated tablets


Oral use




Iceland







Novartis Healthcare A/S




Lyngbyvej 172




2100 Kopenhagen Ø




Denmark






Famvir


125 mg


Film-coated tablets


Oral use




Iceland







Novartis Healthcare A/S




Lyngbyvej 172




2100 Kopenhagen Ø




Denmark






Famvir


500 mg


Film-coated tablets


Oral use




Ireland







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Famvir


125 mg


Film-coated tablets


Oral use




Ireland







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Famvir


250 mg


Film-coated tablets


Oral use




Ireland







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Famvir


750 mg


Film-coated tablets


Oral use




Italy







Novartis Farma S.p.A.




Largo Umberto Boccioni 1




I-21040 Origgio




Italy






Famvir


125 mg


Film-coated tablets


Oral use




Italy







Novartis Farma S.p.A.




Largo Umberto Boccioni 1




I-21040 Origgio




Italy






Famvir


250 mg


Film-coated tablets


Oral use




Italy







Novartis Farma S.p.A.




Largo Umberto Boccioni 1




I-21040 Origgio




Italy






Famvir


500 mg


Film-coated tablets


Oral use




Italy







Sandoz S.p.A.




Largo Umberto Boccioni 1




I-21040 Origgio




Italy






Famciclovir Sandoz


125 mg


Film-coated tablets


Oral use




Italy







Sandoz S.p.A.




Largo Umberto Boccioni 1




I-21040 Origgio




Italy






Famciclovir Sandoz


250 mg


Film-coated tablets


Oral use




Italy







Sandoz S.p.A.




Largo Umberto Boccioni 1




I-21040 Origgio




Italy






Famciclovir Sandoz


500 mg


Film-coated tablets


Oral use




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Famvir 125 mg Filmtabletten


125 mg


Film-coated tablets


Oral use




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Famvir 250 mg Filmtabletten


250 mg


Film-coated tablets


Oral use




Luxembourg







Novartis Pharma GmbH




Roonstrasse 25




D-90429 Nürnberg




Germany






Famvir Zoster 250 mg Filmtabletten


250 mg


Film-coated tablets


Oral use




Malta







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Famvir


125 mg


Film-coated tablets


Oral use




Malta







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Famvir


250 mg


Film-coated tablets


Oral use




Netherlands







Novartis Pharma B.V.




P.O. Box 241




6800 LZ Arnhem




The Netherlands






Famvir


125 mg


Film-coated tablets


Oral use




Netherlands







Novartis Pharma B.V.




P.O. Box 241




6800 LZ Arnhem




The Netherlands






Famvir


250 mg


Film-coated tablets


Oral use




Netherlands







Novartis Pharma B.V.




P.O. Box 241




6800 LZ Arnhem




The Netherlands






Famvir


500 mg


Film-coated tablets


Oral use




Spain







Novartis Farmacéutica S.A.




Gran Via de les Corts Catalanes 764.




E-08013 Barcelona




Spain






Famvir


125 mg


Film-coated tablets


Oral use




Spain







Novartis Farmacéutica S.A.




Gran Via de les Corts Catalanes 764.




E-08013 Barcelona




Spain






Famvir


250 mg


Film-coated tablets


Oral use




Spain







Novartis Farmacéutica S.A.




Gran Via de les Corts Catalanes 764.




E-08013 Barcelona




Spain






Famvir


500 mg


Film-coated tablets


Oral use




Spain







Novartis Farmacéutica S.A.




Gran Via de les Corts Catalanes 764.




E-08013 Barcelona




Spain






Famvir


750 mg


Film-coated tablets


Oral use




Sweden







Novartis Sverige AB




Box 1150




183 11 Täby




Sweden






Famvir


125 mg


Film-coated tablets


Oral use




Sweden







Novartis Sverige AB




Box 1150




183 11 Täby




Sweden






Famvir


250 mg


Film-coated tablets


Oral use




Sweden







Novartis Sverige AB




Box 1150




183 11 Täby




Sweden






Famvir


500 mg


Film-coated tablets


Oral use




United Kingdom







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Famvir


125 mg


Film-coated tablets


Oral use




United Kingdom







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Famvir


250 mg


Film-coated tablets


Oral use




United Kingdom







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Famvir


500 mg


Film-coated tablets


Oral use




United Kingdom







Novartis Pharmaceuticals UK Ltd




Frimley Business Park




Frimley, Camberley




Surrey GU16 7SR




United Kingdom






Famvir


750 mg


Film-coated tablets


Oral use







ANNEX VIII

LIST OF THE NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State EU


Marketing Authorisation Holder


(Invented) name


Strength


Pharmaceutical Form


Route of administration




Austria







Roche Austria GmbH,




Engelhorngasse 3,




A - 1211 Vienna




Austria






Inhibace ‘Roche’ 0,5 mg - Filmtabletten


0,5 mg


Film-coated tablets


Oral use




Austria







Roche Austria GmbH,




Engelhorngasse 3,




A - 1211 Vienna




Austria






Inhibace ‘Roche’ 2,5 mg - Filmtabletten


2,5 mg


Film-coated tablets


Oral use




Austria







Roche Austria GmbH,




Engelhorngasse 3,




A - 1211 Vienna




Austria






Inhibace ‘Roche’ 5 mg - Filmtabletten


5 mg


Film-coated tablets


Oral use




Belgium







N.V. Roche S.A.




Rue Dante 75




1070 Bruxelles




Belgium






Inhibace


0,5 mg


Film-coated tablets


Oral use




Belgium







N.V. Roche S.A.




Rue Dante 75




1070 Bruxelles




Belgium






Inhibace


5 mg


Film-coated tablets


Oral use




Bulgaria







Roche Bulgaria EOOD




16, Bvalo pole Str.




1618 / Sofia




Bulgaria






Inhibace


1 mg


Film-coated tablets


Oral use




Bulgaria







Roche Bulgaria EOOD




16, Bvalo pole Str.




1618 / Sofia




Bulgaria






Inhibace


2,5 mg


Film-coated tablets


Oral use




Bulgaria







Roche Bulgaria EOOD




16, Bvalo pole Str.




1618 / Sofia




Bulgaria






Inhibace


5 mg


Film-coated tablets


Oral use




Czech Republic







Roche s.r.o.




Dukelskych hrdinu 567/52




170 00 / Praha 7




Czech Republic






Inhibace 2,5 mg


2,5 mg


Film-coated tablets


Oral use




Czech Republic







Roche s.r.o.




Dukelskych hrdinu 567/52




170 00 / Praha 7




Czech Republic






Inhibace 5 mg


5 mg


Film-coated tablets


Oral use




France







Chiesi SA




Immeuble le Doublon, bâtiment B




11 avenue Dubonnet




92 400 Courbevoie




France






Justor 0,5 mg


0,5 mg


Film-coated tablets


Oral use




France







Chiesi SA




Immeuble le Doublon, bâtiment B




11 avenue Dubonnet




92 400 Courbevoie




France






Justor 1 mg


1 mg


Film-coated tablets


Oral use




France







Chiesi SA




Immeuble le Doublon, bâtiment B




11 avenue Dubonnet




92 400 Courbevoie




France






Justor 2,5 mg


2,5 mg


Film-coated tablets


Oral use




Germany







Roche Pharma AG




Emil-Barell-Strasse 1




79639/Grenzach




Germany






Dynorm 0,5


0,5 mg


Film-coated tablets


Oral use




Germany







Roche Pharma AG




Emil-Barell-Strasse 1




79639/Grenzach




Germany






Dynorm 1,0


1 mg


Film-coated tablets


Oral use




Germany







Roche Pharma AG




Emil-Barell-Strasse 1




79639/Grenzach




Germany






Dynorm 2,5


2,5 mg


Film-coated tablets


Oral use




Germany







Roche Pharma AG




Emil-Barell-Strasse 1




79639/Grenzach




Germany






Dynorm 5,0


5 mg


Film-coated tablets


Oral use




Greece







Roche (Hellas) SA




4, Alamanas & Delfon Str.




Maroussi 15125




Attiki




Greece






Vascace


0,5 mg


Film-coated tablets


Oral use




Greece







Roche (Hellas) SA




4, Alamanas & Delfon Str.




Maroussi 15125




Attiki




Greece






Vascace


1 mg


Film-coated tablets


Oral use




Greece







Roche (Hellas) SA




4, Alamanas & Delfon Str.




Maroussi 15125




Attiki




Greece






Vascace


2,5 mg


Film-coated tablets


Oral use




Greece







Roche (Hellas) SA




4, Alamanas & Delfon Str.




Maroussi 15125




Attiki




Greece






Vascace


5 mg


Film-coated tablets


Oral use




Hungary







Roche Hungary Ltd




Edison ut 1




2040 / Budaörs




Hungary






Inhibace


1 mg


Film-coated tablets


Oral use




Hungary







Roche Hungary Ltd




Edison ut 1




2040 / Budaörs




Hungary






Inhibace


2,5 mg


Film-coated tablets


Oral use




Hungary







Roche Hungary Ltd




Edison ut 1




2040 / Budaörs




Hungary






Inhibace


5 mg


Film-coated tablets


Oral use




Ireland







Roche Products Ltd




6 Falcon Way, Shire Park




Welwyn Garden City / AL7 1TW




United Kingdom






Vascace


0,5 mg


Film-coated tablets


Oral use




Ireland







Roche Products Ltd




6 Falcon Way, Shire Park




Welwyn Garden City / AL7 1TW




United Kingdom






Vascace


1 mg


Film-coated tablets


Oral use




Ireland







Roche Products Ltd




6 Falcon Way, Shire Park




Welwyn Garden City / AL7 1TW




United Kingdom






Vascace


2,5 mg


Film-coated tablets


Oral use




Ireland







Roche Products Ltd




6 Falcon Way, Shire Park




Welwyn Garden City / AL7 1TW




United Kingdom






Vascace


5 mg


Film-coated tablets


Oral use




Italy







Roche S.p.A




Via G.B Stucchi 110




20052/Monza




Italy






Inibace


1 mg


Film-coated tablets


Oral use




Italy







Roche S.p.A




Via G.B Stucchi 110




20052/Monza




Italy






Inibace


5 mg


Film-coated tablets


Oral use




Luxembourg







N.V. Roche S.A.




Rue Dante 75




1070 Bruxelles




Belgium






Inhibace


0,5 mg


Film-coated tablets


Oral use




Luxembourg







N.V. Roche S.A.




Rue Dante 75




1070 Bruxelles




Belgium






Inhibace


5 mg


Film-coated tablets


Oral use




Netherlands







Roche Nederland BV




Beneluxlaan 2A




3446 GG Woerden




Netherlands






Vascase 0,5


0,5 mg


Film-coated tablets


Oral use




Netherlands







Roche Nederland BV




Beneluxlaan 2A




3446 GG Woerden




Netherlands






Vascase 2,5


2,5 mg


Film-coated tablets


Oral use




Netherlands







Roche Nederland BV




Beneluxlaan 2A




3446 GG Woerden




Netherlands






Vascase 5


5 mg


Film-coated tablets


Oral use




Poland







Roche Polska Sp.z.o.o.




Ul. Domaniewska 39B




02-672 / Warsaw




Poland






Inhibace


0,5 mg


Film-coated tablets


Oral use




Poland







Roche Polska Sp.z.o.o.




Ul. Domaniewska 39B




02-672 / Warsaw




Poland






Inhibace


1 mg


Film-coated tablets


Oral use




Poland







Roche Polska Sp.z.o.o.




Ul. Domaniewska 39B




02-672 / Warsaw




Poland






Inhibace


2,5 mg


Film-coated tablets


Oral use




Poland







Roche Polska Sp.z.o.o.




Ul. Domaniewska 39B




02-672 / Warsaw




Poland






Inhibace


5 mg


Film-coated tablets


Oral use




Portugal







Roche Farmacêutica Química, Lda.




Estrada Nacional 249-1




2720-413 / Amadora




Portugal






Inibace


1 mg


Film-coated tablets


Oral use




Portugal







Roche Farmacêutica Química, Lda.




Estrada Nacional 249-1




2720-413 / Amadora




Portugal






Inibace


2,5 mg


Film-coated tablets


Oral use




Portugal







Roche Farmacêutica Química, Lda.




Estrada Nacional 249-1




2720-413 / Amadora




Portugal






Inibace


5 mg


Film-coated tablets


Oral use




Spain







Roche Farma S.A.




Eucalipto no 33




28016 / Madrid




Spain






Inhibace


1 mg


Film-coated tablets


Oral use




Spain







Roche Farma S.A.




Eucalipto no 33




28016 / Madrid




Spain






Inhibace


2,5 mg


Film-coated tablets


Oral use




Spain







Roche Farma S.A.




Eucalipto no 33




28016 / Madrid




Spain






Inhibace


5 mg


Film-coated tablets


Oral use




United Kingdom







Roche Products Ltd




6 Falcon Way, Shire Park




Welwyn Garden City / AL7 1TW




United Kingdom






Vascace


0,5 mg


Film-coated tablets


Oral use




United Kingdom







Roche Products Ltd




6 Falcon Way, Shire Park




Welwyn Garden City / AL7 1TW




United Kingdom






Vascace


1 mg


Film-coated tablets


Oral use




United Kingdom







Roche Products Ltd




6 Falcon Way, Shire Park




Welwyn Garden City / AL7 1TW




United Kingdom






Vascace


2,5 mg


Film-coated tablets


Oral use




United Kingdom







Roche Products Ltd




6 Falcon Way, Shire Park




Welwyn Garden City / AL7 1TW




United Kingdom






Vascace


5 mg


Film-coated tablets


Oral use







ANNEX IX

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTH OF THE MEDICINAL PRODUCT, ROUTES OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES











Member State EU/EEA


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical Form


Route of administration




Austria







AstraZeneca Österreich GmbH.,




Schwarzenbergplatz 7,




A-1037 Wien, Austria






Atacand 2 mg - Tabletten


2 mg


Tablet


Oral use




Austria







AstraZeneca Österreich GmbH.,




Schwarzenbergplatz 7,




A-1037 Wien, Austria






Atacand 4 mg - Tabletten


4 mg


Tablet


Oral use




Austria







AstraZeneca Österreich GmbH.,




Schwarzenbergplatz 7,




A-1037 Wien, Austria






Atacand 8 mg - Tabletten


8 mg


Tablet


Oral use




Austria







AstraZeneca Österreich GmbH.,




Schwarzenbergplatz 7,




A-1037 Wien, Austria






Atacand 16 mg - Tabletten


16 mg


Tablet


Oral use




Austria







AstraZeneca Österreich GmbH.,




Schwarzenbergplatz 7,




A-1037 Wien, Austria






Atacand 32 mg - Tabletten


32 mg


Tablet


Oral use




Austria







Takeda Pharma Ges.m.b.H.




Seidengasse 33-35




1070 Wien




Austria






Blopress 4 mg – Tabletten


4 mg


Tablet


Oral use




Austria







Takeda Pharma Ges.m.b.H.




Seidengasse 33-35




1070 Wien




Austria






Blopress 8 mg – Tabletten


8 mg


Tablet


Oral use




Austria







Takeda Pharma Ges.m.b.H.




Seidengasse 33-35




1070 Wien




Austria






Blopress 16 mg – Tabletten


16 mg


Tablet


Oral use




Austria







Takeda Pharma Ges.m.b.H.




Seidengasse 33-35




1070 Wien




Austria






Blopress 32 mg – Tabletten


32 mg


Tablet


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand


2 mg


Tablet


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand


4 mg


Tablet


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand


8 mg


Tablet


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand


16 mg


Tablet


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand


32 mg


Tablet


Oral use




Bulgaria







AstraZeneca AB,




S-151 85 Södertälje, Sweden






Atacand


8 mg


Tablet


Oral use




Bulgaria







AstraZeneca AB,




S-151 85 Södertälje, Sweden






Atacand


16 mg


Tablet


Oral use




Bulgaria







AstraZeneca AB,




S-151 85 Södertälje, Sweden






Atacand


32 mg


Tablet


Oral use




Cyprus







AstraZeneca AB,




S-151 85 Södertälje, Sweden






Atacand


4 mg


Tablet


Oral use




Cyprus







AstraZeneca AB,




S-151 85 Södertälje, Sweden






Atacand


8 mg


Tablet


Oral use




Cyprus







AstraZeneca AB,




S-151 85 Södertälje, Sweden






Atacand


16 mg


Tablet


Oral use




Cyprus







AstraZeneca AB,




S-151 85 Södertälje, Sweden






Atacand


32 mg


Tablet


Oral use




Czech Republic







AstraZeneca UK Ltd., Macclesfield,




Cheshire, United Kingdom






Atacand 4 mg


4 mg


Tablet


Oral use




Czech Republic







AstraZeneca UK Ltd., Macclesfield,




Cheshire, United Kingdom






Atacand 8 mg


8 mg


Tablet


Oral use




Czech Republic







AstraZeneca UK Ltd., Macclesfield,




Cheshire, United Kingdom






Atacand 16 mg


16 mg


Tablet


Oral use




Denmark







AstraZeneca A/S




Roskildevej 22




DK-2620 Albertslund,




Denmark






Atacand


4 mg


Tablet


Oral use




Denmark







AstraZeneca A/S




Roskildevej 22




DK-2620 Albertslund,




Denmark






Atacand


8 mg


Tablet


Oral use




Denmark







AstraZeneca A/S




Roskildevej 22




DK-2620 Albertslund,




Denmark






Atacand


16 mg


Tablet


Oral use




Denmark







AstraZeneca A/S




Roskildevej 22




DK-2620 Albertslund,




Denmark






Atacand


32 mg


Tablet


Oral use




Estonia







AstraZeneca AB, Strängnäsvägen 44,




S-151 85 Södertälje, Sweden






Atacand


8 mg


Tablet


Oral use




Estonia







AstraZeneca AB, Strängnäsvägen 44,




S-151 85 Södertälje, Sweden






Atacand


16 mg


Tablet


Oral use




Estonia







AstraZeneca AB, Strängnäsvägen 44,




S-151 85 Södertälje, Sweden






Atacand


32 mg


Tablet


Oral use




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Atacand


2 mg


Tablet


Oral use




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Atacand


4 mg


Tablet


Oral use




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Atacand


8 mg


Tablet


Oral use




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Atacand


16 mg


Tablet


Oral use




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Atacand


32 mg


Tablet


Oral use




France







AstraZeneca




1, Place Renault




92844 Rueil-




Malmaison Cedex




France






Atacand 4 mg, comprimé sécable


4 mg


Tablet


Oral use




France







AstraZeneca




1, Place Renault




92844 Rueil-




Malmaison Cedex




France






Atacand 8 mg, comprimé sécable


8 mg


Tablet


Oral use




France







AstraZeneca




1, Place Renault




92844 Rueil-




Malmaison Cedex




France






Atacand 16 mg, comprimé sécable


16 mg


Tablet


Oral use




France







AstraZeneca




1, Place Renault




92844 Rueil-




Malmaison Cedex




France






Atacand 32 mg, comprimé sécable


32 mg


Tablet


Oral use




France







Laboratoires Takeda




11-15, quai de Dion Bouton




92816 Puteaux Cedex




France






Kenzen 4 mg, comprimé sécable


4 mg


Tablet


Oral use




France







Laboratoires Takeda




11-15, quai de Dion Bouton




92816 Puteaux Cedex




France






Kenzen 8 mg, comprimé sécable


8 mg


Tablet


Oral use




France







Laboratoires Takeda




11-15, quai de Dion Bouton




92816 Puteaux Cedex




France






Kenzen 16 mg, comprimé sécable


16 mg


Tablet


Oral use




France







Laboratoires Takeda




11-15, quai de Dion Bouton




92816 Puteaux Cedex




France






Kenzen 32 mg, comprimé sécable


32 mg


Tablet


Oral use




Germany







AstraZeneca GmbH




22876 Wedel, Germany






Atacand 4 mg


4 mg


Tablet


Oral use




Germany







AstraZeneca GmbH




22876 Wedel, Germany






Atacand 8 mg


8 mg


Tablet


Oral use




Germany







AstraZeneca GmbH




22876 Wedel, Germany






Atacand 16 mg


16 mg


Tablet


Oral use




Germany







AstraZeneca GmbH




22876 Wedel, Germany






Atacand PROTECT 32 mg Tabletten


32 mg


Tablet


Oral use




Germany







Takeda Pharma GmbH




Viktoriaallee 3-5




52066 Aachen




Germany






Blopress 2 mg Tabletten


2 mg


Tablet


Oral use




Germany







Takeda Pharma GmbH




Viktoriaallee 3-5




52066 Aachen




Germany






Blopress 4 mg Tabletten


4 mg


Tablet


Oral use




Germany







Takeda Pharma GmbH




Viktoriaallee 3-5




52066 Aachen




Germany






Blopress 8 mg Tabletten


8 mg


Tablet


Oral use




Germany







Takeda Pharma GmbH




Viktoriaallee 3-5




52066 Aachen




Germany






Blopress 16 mg Tabletten


16 mg


Tablet


Oral use




Germany







Takeda Pharma GmbH




Viktoriaallee 3-5




52066 Aachen




Germany






Blopress 32 mg Tabletten


32 mg


Tablet


Oral use




Greece







AstraZeneca SA




Theotokopoulou 4 & Astrnafton




151 25 Maroussi




Greece






Atacand


2 mg


Tablet


Oral use




Greece







AstraZeneca SA




Theotokopoulou 4 & Astronafton




151 25 Maroussi




Greece






Atacand


4 mg


Tablet


Oral use




Greece







AstraZeneca SA




Theotokopoulou 4 & Astronafton




151 25 Maroussi




Greece






Atacand


8 mg


Tablet


Oral use




Greece







AstraZeneca SA




Theotokopoulou 4 & Astronafton




151 25 Maroussi




Greece






Atacand


16 mg


Tablet


Oral use




Greece







AstraZeneca SA




Theotokopoulou 4 & Astronafton




151 25 Maroussi




Greece






Atacand


32 mg


Tablet


Oral use




Hungary







AstraZeneca Kft.




1113 Budapest,




Bocskai út 134-146




Hungary






Atacand


8 mg


Tablet


Oral use




Hungary







AstraZeneca Kft.




1113 Budapest,




Bocskai út 134-146




Hungary






Atacand


16 mg


Tablet


Oral use




Iceland







AstraZeneca A/S




Roskildevej 22,




DK-2620 Albertslund,




Denmark






Atacand


4 mg


Tablet


Oral use




Iceland







AstraZeneca A/S




Roskildevej 22,




DK-2620 Albertslund,




Denmark






Atacand


8 mg


Tablet


Oral use




Iceland







AstraZeneca A/S




Roskildevej 22,




DK-2620 Albertslund,




Denmark






Atacand


16 mg


Tablet


Oral use




Iceland







AstraZeneca A/S




Roskildevej 22,




DK-2620 Albertslund,




Denmark






Atacand


32 mg


Tablet


Oral use




Ireland







AstraZeneca UK Limited,




600 Capability Green, Luton,




LU1 3LU, United Kingdom






Atacand


2 mg


Tablet


Oral use




Ireland







AstraZeneca UK Limited,




600 Capability Green, Luton,




LU1 3LU, United Kingdom






Atacand


4 mg


Tablet


Oral use




Ireland







AstraZeneca UK Limited,




600 Capability Green, Luton,




LU1 3LU, United Kingdom






Atacand


8 mg


Tablet


Oral use




Ireland







AstraZeneca UK Limited,




600 Capability Green, Luton,




LU1 3LU, United Kingdom






Atacand


16 mg


Tablet


Oral use




Ireland







AstraZeneca UK Limited,




600 Capability Green, Luton,




LU1 3LU, United Kingdom






Atacand


32 mg


Tablet


Oral use




Ireland







Takeda UK Limited




Takeda House, Mercury Park,




Wycombe Lane, Wooburn Green,




High Wycombe,




Buckinghamshire




HP10 OHH




United Kingdom






Blopress 2 mg


2 mg


Tablet


Oral use




Ireland







Takeda UK Limited




Takeda House, Mercury Park,




Wycombe Lane, Wooburn Green,




High Wycombe,




Buckinghamshire




HP10 OHH




United Kingdom






Blopress 4 mg


4 mg


Tablet


Oral use




Ireland







Takeda UK Limited




Takeda House, Mercury Park,




Wycombe Lane, Wooburn Green,




High Wycombe,




Buckinghamshire




HP10 OHH




United Kingdom






Blopress 8 mg


8 mg


Tablet


Oral use




Ireland







Takeda UK Limited




Takeda House, Mercury Park,




Wycombe Lane, Wooburn Green,




High Wycombe,




Buckinghamshire




HP10 OHH




United Kingdom






Blopress 16 mg


16 mg


Tablet


Oral use




Ireland







Takeda UK Limited




Takeda House, Mercury Park,




Wycombe Lane, Wooburn Green,




High Wycombe,




Buckinghamshire




HP10 OHH




United Kingdom






Blopress 32 mg


32 mg


Tablet


Oral use




Italy







AstraZeneca SpA




Palazzo Volta, via F.Sforza – 20080




Basiglio (MI) –Italy






Ratacand


2 mg


Tablet


Oral use




Italy







AstraZeneca SpA




Palazzo Volta, via F.Sforza – 20080




Basiglio (MI) –Italy






Ratacand


4 mg


Tablet


Oral use




Italy







AstraZeneca SpA




Palazzo Volta, via F.Sforza – 20080




Basiglio (MI) –Italy






Ratacand


8 mg


Tablet


Oral use




Italy







AstraZeneca SpA




Palazzo Volta, via F.Sforza – 20080




Basiglio (MI) –Italy






Ratacand


16 mg


Tablet


Oral use




Italy







AstraZeneca SpA




Palazzo Volta, via F.Sforza – 20080




Basiglio (MI) –Italy






Ratacand


32 mg


Tablet


Oral use




Italy







Takeda Italia Farmaceutici S.p.A.




Via Elio Vittorini, 129




00144 Roma




Italy






Blopress 2 mg


2 mg


Tablet


Oral use




Italy







Takeda Italia Farmaceutici S.p.A.




Via Elio Vittorini, 129




00144 Roma




Italy






Blopress 4 mg


4 mg


Tablet


Oral use




Italy







Takeda Italia Farmaceutici S.p.A.




Via Elio Vittorini, 129




00144 Roma




Italy






Blopress 8 mg


8 mg


Tablet


Oral use




Italy







Takeda Italia Farmaceutici S.p.A.




Via Elio Vittorini, 129




00144 Roma




Italy






Blopress 16 mg


16 mg


Tablet


Oral use




Italy







Takeda Italia Farmaceutici S.p.A.




Via Elio Vittorini, 129




00144 Roma




Italy






Blopress 32 mg


32 mg


Tablet


Oral use




Latvia







AstraZeneca AB




S-151 85 Södertälje, Sweden






Atacand


8 mg


Tablet


Oral use




Latvia







AstraZeneca AB




S-151 85 Södertälje, Sweden






Atacand


16 mg


Tablet


Oral use




Lithuania







AstraZeneca AB




S-151 85 Södertälje, Sweden






Atacand


4 mg


Tablet


Oral use




Lithuania







AstraZeneca AB




S-151 85 Södertälje, Sweden






Atacand


8 mg


Tablet


Oral use




Lithuania







AstraZeneca AB




S-151 85 Södertälje, Sweden






Atacand


16 mg


Tablet


Oral use




Lithuania







AstraZeneca AB




S-151 85 Södertälje, Sweden






Atacand


32 mg


Tablet


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand


2 mg


Tablet


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand


4 mg


Tablet


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand


8 mg


Tablet


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand


16 mg


Tablet


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussels




Belgium






Atacand


32 mg


Tablet


Oral use




Malta







AstraZeneca AB, Gärtunavägen,




S-15185, Södertälje, Sweden






Atacand


8 mg


Tablet


Oral use




Malta







AstraZeneca AB, Gärtunavägen,




S-15185, Södertälje, Sweden






Atacand


16 mg


Tablet


Oral use




Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Atacand 2, tabletten 2 mg


2 mg


Tablet


Oral use




Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Atacand 4, tabletten 4 mg


4 mg


Tablet


Oral use




Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Atacand 8, tabletten 8 mg


8 mg


Tablet


Oral use




Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Atacand 16, tabletten 16 mg


16 mg


Tablet


Oral use




Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Atacand 32, tabletten 32 mg


32 mg


Tablet


Oral use




Norway







AstraZeneca AS




Boks 200 Vinderen




NO-0319 Oslo, Norway






Atacand


4 mg


Tablet


Oral use




Norway







AstraZeneca AS




Boks 200 Vinderen




NO-0319 Oslo, Norway






Atacand


8 mg


Tablet


Oral use




Norway







AstraZeneca AS




Boks 200 Vinderen




NO-0319 Oslo, Norway






Atacand


16 mg


Tablet


Oral use




Norway







AstraZeneca AS




Boks 200 Vinderen




NO-0319 Oslo, Norway






Atacand


32 mg


Tablet


Oral use




Poland







AstraZeneca AB, S-151 85 Södertälje,




Gärtunavägen, Sweden






Atacand


4 mg


Tablet


Oral use




Poland







AstraZeneca AB, S-151 85 Södertälje,




Gärtunavägen, Sweden






Atacand


8 mg


Tablet


Oral use




Poland







AstraZeneca AB, S-151 85 Södertälje,




Gärtunavägen, Sweden






Atacand


16 mg


Tablet


Oral use




Poland







AstraZeneca AB, S-151 85 Södertälje,




Gärtunavägen, Sweden






Atacand


32 mg


Tablet


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7,




Valejas 2745-663 Barcarena, Portugal






Atacand


2 mg


Tablet


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7,




Valejas 2745-663 Barcarena, Portugal






Atacand


4 mg


Tablet


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7,




Valejas 2745-663 Barcarena, Portugal






Atacand


8 mg


Tablet


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7,




Valejas 2745-663 Barcarena, Portugal






Atacand


16 mg


Tablet


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7,




Valejas 2745-663 Barcarena, Portugal






Atacand 32 mg


32 mg


Tablet


Oral use




Portugal







Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.




Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo




2730-055 Barcarena




Portugal






Blopress


2 mg


Tablet


Oral use




Portugal







Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.




Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo




2730-055 Barcarena




Portugal






Blopress


4 mg


Tablet


Oral use




Portugal







Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.




Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo




2730-055 Barcarena




Portugal






Blopress


8 mg


Tablet


Oral use




Portugal







Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.




Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo




2730-055 Barcarena




Portugal






Blopress


16 mg


Tablet


Oral use




Portugal







Lusomedicamenta - Sociedade Técnica Farmacêutica, S.A.




Estrada Consiglieri Pedroso, 69 B - Queluz de Baixo




2730-055 Barcarena




Portugal






Blopress


32 mg


Tablet


Oral use




Romania







AstraZeneca AB,




S 151 85, Södertälje, Sweden






Atacand 8 mg


8 mg


Tablet


Oral use




Romania







AstraZeneca AB,




S 151 85, Södertälje, Sweden






Atacand 16 mg


16 mg


Tablet


Oral use




Romania







AstraZeneca AB,




S 151 85, Södertälje, Sweden






Atacand 32 mg


32 mg


Tablet


Oral use




Slovak Republic







AstraZeneca AB,




S-151 85 Södertälje, Sweden






Atacand 8 mg


8 mg


Tablet


Oral use




Slovak Republic







AstraZeneca AB,




S-151 85 Södertälje, Sweden






Atacand 16 mg


16 mg


Tablet


Oral use




Slovak Republic







AstraZeneca AB,




S-151 85 Södertälje, Sweden






Atacand 32 mg


32 mg


Tablet


Oral use




Slovenia







AstraZeneca UK Limited




15 Stanhope Gate




London W1K 1LN




United Kingdom






Atacand 4 mg


4 mg


Tablet


Oral use




Slovenia







AstraZeneca UK Limited




15 Stanhope Gate




London W1K 1LN




United Kingdom






Atacand 8 mg


8 mg


Tablet


Oral use




Slovenia







AstraZeneca UK Limited




15 Stanhope Gate




London W1K 1LN




United Kingdom






Atacand 16 mg


16 mg


Tablet


Oral use




Slovenia







AstraZeneca UK Limited




15 Stanhope Gate




London W1K 1LN




United Kingdom






Atacand 32 mg


32 mg


Tablet


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte.Edificio Roble.




C/ Serrano Galvache 56




28033 Madrid, Spain






Atacand 4 mg comprimidos


4 mg


Tablet


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte.Edificio Roble.




C/ Serrano Galvache 56




28033 Madrid, Spain






Atacand 8 mg comprimidos


8 mg


Tablet


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte.Edificio Roble.




C/ Serrano Galvache 56




28033 Madrid, Spain






Atacand 16 mg comprimidos


16 mg


Tablet


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




Parque Norte.Edificio Roble.




C/ Serrano Galvache 56




28033 Madrid, Spain






Atacand 32 mg comprimidos


32 mg


Tablet


Oral use




Spain







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych




London




WC2B 4AE




United Kingdom






Blopress 4 mg comprimidos


4 mg


Tablet


Oral use




Spain







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych




London




WC2B 4AE




United Kingdom






Blopress 8 mg comprimidos


8 mg


Tablet


Oral use




Spain







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych




London




WC2B 4AE




United Kingdom






Blopress 16 mg comprimidos


16 mg


Tablet


Oral use




Spain







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych




London




WC2B 4AE




United Kingdom






Blopress 32 mg comprimidos


32 mg


Tablet


Oral use




Spain







Almirall, S.A. Ronda General Mitre, 151




08022 Barcelona




Spain






Parapres 4 mg comprimidos


4 mg


Tablet


Oral use




Spain







Almirall, S.A. Ronda General Mitre, 151




08022 Barcelona




Spain






Parapres 8 mg comprimidos


8 mg


Tablet


Oral use




Spain







Almirall, S.A. Ronda General Mitre, 151




08022 Barcelona




Spain






Parapres 16 mg comprimidos


16 mg


Tablet


Oral use




Spain







Almirall, S.A. Ronda General Mitre, 151




08022 Barcelona




Spain






Parapres 32 mg comprimidos


32 mg


Tablet


Oral use




Sweden







AstraZeneca AB




151 85 Södertälje, Sweden






Atacand


2 mg


Tablet


Oral use




Sweden







AstraZeneca AB




151 85 Södertälje, Sweden






Atacand


4 mg


Tablet


Oral use




Sweden







AstraZeneca AB




151 85 Södertälje, Sweden






Atacand


8 mg


Tablet


Oral use




Sweden







AstraZeneca AB




151 85 Södertälje, Sweden






Atacand


16 mg


Tablet


Oral use




Sweden







AstraZeneca AB




151 85 Södertälje, Sweden






Atacand


32 mg


Tablet


Oral use




Sweden







AstraZeneca AB




151 85 Södertälje, Sweden






Racanda


4 mg


Tablet


Oral use




Sweden







AstraZeneca AB




151 85 Södertälje, Sweden






Racanda


8 mg


Tablet


Oral use




Sweden







AstraZeneca AB




151 85 Södertälje, Sweden






Racanda


16 mg


Tablet


Oral use




Sweden







AstraZeneca AB




151 85 Södertälje, Sweden






Racanda


32 mg


Tablet


Oral use




United Kingdom







AstraZeneca UK Limited,




600 Capability Green, Luton,




LU1 3LU, United Kingdom






Atacand


2 mg


Tablet


Oral use




United Kingdom







AstraZeneca UK Limited,




600 Capability Green, Luton,




LU1 3LU, United Kingdom






Atacand


4 mg


Tablet


Oral use




United Kingdom







AstraZeneca UK Limited,




600 Capability Green, Luton,




LU1 3LU, United Kingdom






Atacand


8 mg


Tablet


Oral use




United Kingdom







AstraZeneca UK Limited,




600 Capability Green, Luton,




LU1 3LU, United Kingdom






Atacand


16 mg


Tablet


Oral use




United Kingdom







AstraZeneca UK Limited,




600 Capability Green, Luton,




LU1 3LU, United Kingdom






Atacand


32 mg


Tablet


Oral use




United Kingdom







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych




London




WC2B 4AE




United Kingdom






Blopress 2 mg


2 mg


Tablet


Oral use




United Kingdom







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych




London




WC2B 4AE




United Kingdom






Blopress 4 mg


4 mg


Tablet


Oral use




United Kingdom







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych




London




WC2B 4AE




United Kingdom






Blopress 8 mg


8 mg


Tablet


Oral use




United Kingdom







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych




London




WC2B 4AE




United Kingdom






Blopress 16 mg


16 mg


Tablet


Oral use




United Kingdom







Takeda Global Research and Development Centre (Europe) Ltd




61 Aldwych




London




WC2B 4AE




United Kingdom






Blopress 32 mg


32 mg


Tablet


Oral use




United Kingdom







Takeda UK Limited




Takeda House, Mercury Park,




Wycombe Lane, Wooburn Green,




High Wycombe,




Buckinghamshire




HP10 OHH




United Kingdom






Amias 2 mg


2 mg


Tablet


Oral use




United Kingdom







Takeda UK Limited




Takeda House, Mercury Park,




Wycombe Lane, Wooburn Green,




High Wycombe,




Buckinghamshire




HP10 OHH




United Kingdom






Amias 4 mg


4 mg


Tablet


Oral use




United Kingdom







Takeda UK Limited




Takeda House, Mercury Park,




Wycombe Lane, Wooburn Green,




High Wycombe,




Buckinghamshire




HP10 OHH




United Kingdom






Amias 8 mg


8 mg


Tablet


Oral use




United Kingdom







Takeda UK Limited




Takeda House, Mercury Park,




Wycombe Lane, Wooburn Green,




High Wycombe,




Buckinghamshire




HP10 OHH




United Kingdom






Amias 16 mg


16 mg


Tablet


Oral use




United Kingdom







Takeda UK Limited




Takeda House, Mercury Park,




Wycombe Lane, Wooburn Green,




High Wycombe,




Buckinghamshire




HP10 OHH




United Kingdom






Amias 32 mg


32 mg


Tablet


Oral use







ANNEX X

LIST OF THE NAMES, PHARMACEUTICAL FORM(S), STRENGTH(S) OF THE MEDICINAL PRODUCT(S), ROUTE(S) OF ADMINISTRATION, APPLICANT(S)/MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES











Member State EU/EEA


Marketing Authorisation Holder


Invented name
Name


Strength


Pharmaceutical Form


Route of administration




Austria







Pfizer Corporation Austria Ges.m.b.H.




Floridsdorfer Hauptstraße 1




A - 1210 Wien Austria






Sortis 10 mg - Filmtabletten


10 mg


Film-coated tablet


Oral use




Austria







Pfizer Corporation Austria Ges.m.b.H.




Floridsdorfer Hauptstraße 1




A - 1210 Wien Austria






Sortis 20 mg - Filmtabletten


20 mg


Film-coated tablet


Oral use




Austria







Pfizer Corporation Austria Ges.m.b.H.




Floridsdorfer Hauptstraße 1




A - 1210 Wien Austria






Sortis 40 mg - Filmtabletten


40 mg


Film-coated tablet


Oral use




Austria







Pfizer Corporation Austria Ges.m.b.H.




Floridsdorfer Hauptstraße 1




A - 1210 Wien Austria






Sortis 80 mg - Filmtabletten


80 mg


Film-coated tablet


Oral use




Belgium







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels, Belgium






Lipitor


10 mg


Film-coated tablet


Oral use




Belgium







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels, Belgium






Lipitor


20 mg


Film-coated tablet


Oral use




Belgium







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels, Belgium






Lipitor


40 mg


Film-coated tablet


Oral use




Belgium







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels, Belgium






Lipitor


80 mg


Film-coated tablet


Oral use




Bulgaria







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


10 mg


Film-coated tablet


Oral use




Bulgaria







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


20 mg


Film-coated tablet


Oral use




Bulgaria







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


40 mg


Film-coated tablet


Oral use




Bulgaria







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


80 mg


Film-coated tablet


Oral use




Cyprus







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens, Greece






Lipitor


10 mg


Film-coated tablet


Oral use




Cyprus







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens, Greece






Lipitor


20 mg


Film-coated tablet


Oral use




Cyprus







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens, Greece






Lipitor


40 mg


Film-coated tablet


Oral use




Czech Republic







Pfizer, spol. s r.o.,




Stroupežnického 17, 150 00 Prague 5,




Czech Republic






Sortis


10 mg


Film-coated tablet


Oral use




Czech Republic







Pfizer, spol. s r.o.,




Stroupežnického 17, 150 00 Prague 5,




Czech Republic






Sortis


20 mg


Film-coated tablet


Oral use




Czech Republic







Pfizer, spol. s r.o.,




Stroupežnického 17, 150 00 Prague 5,




Czech Republic






Sortis


40 mg


Film-coated tablet


Oral use




Czech Republic







Pfizer, spol. s r.o.,




Stroupežnického 17, 150 00 Prague 5,




Czech Republic






Sortis


80 mg


Film-coated tablet


Oral use




Denmark







Pfizer ApS,




Lautrupvang 8,




2750 Ballerup,




Denmark






Zarator


10 mg


Film-coated tablet


Oral use




Denmark







Pfizer ApS,




Lautrupvang 8,




2750 Ballerup,




Denmark






Zarator


20 mg


Film-coated tablet


Oral use




Denmark







Pfizer ApS,




Lautrupvang 8, 2750 Ballerup,




Denmark






Zarator


40 mg


Film-coated tablet


Oral use




Denmark







Pfizer ApS,




Lautrupvang 8, 2750 Ballerup,




Denmark






Zarator


80 mg


Film-coated tablet


Oral use




Estonia







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


10 mg


Film-coated tablet


Oral use




Estonia







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


20 mg


Film-coated tablet


Oral use




Estonia







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


40 mg


Film-coated tablet


Oral use




Estonia







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis 80 mg


80 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy,




Tietokuja 4, 00330




Helsinki, Finland






Lipitor


10 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy,




Tietokuja 4, 00330




Helsinki, Finland






Lipitor


20 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy,




Tietokuja 4, 00330




Helsinki, Finland






Lipitor


40 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy,




Tietokuja 4, 00330




Helsinki, Finland






Lipitor


80 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy,




Tietokuja 4, 00330




Helsinki, Finland






Orbeos


10 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy,




Tietokuja 4, 00330




Helsinki, Finland






Orbeos


20 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy,




Tietokuja 4, 00330




Helsinki, Finland






Orbeos


40 mg


Film-coated tablet


Oral use




Finland







Pfizer Oy,




Tietokuja 4, 00330




Helsinki, Finland






Orbeos


80 mg


Film-coated tablet


Oral use




France







Pfizer Holding France




23-25 Avenue du Docteur Lannelongue




75668 Paris Cedex 14




France






Tahor


10 mg


Film-coated tablet


Oral use




France







Pfizer Holding France




23-25 Avenue du Docteur Lannelongue




75668 Paris Cedex 14




France






Tahor


20 mg


Film-coated tablet


Oral use




France







Pfizer Holding France




23-25 Avenue du Docteur Lannelongue




75668 Paris Cedex 14




France






Tahor


40 mg


Film-coated tablet


Oral use




France







Pfizer Holding France




23-25 Avenue du Docteur Lannelongue




75668 Paris Cedex 14




France






Tahor


80 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH,




Linkstraße 10 10785 Berlin,




Germany






Sortis 10 mg


10 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH,




Linkstraße 10 10785 Berlin,




Germany






Sortis 20 mg


20 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH,




Linkstraße 10 10785 Berlin,




Germany






Sortis 40 mg


40 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH,




Linkstraße 10 10785 Berlin,




Germany






Sortis 80 mg


80 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH,




Linkstraße 10 10785 Berlin,




Germany






Liprimar 10 mg


10 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH,




Linkstraße 10 10785 Berlin,




Germany






Liprimar 20 mg


20 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH,




Linkstraße 10 10785 Berlin,




Germany






Liprimar 40 mg


40 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH,




Linkstraße 10 10785 Berlin,




Germany






Liprimar 80 mg


80 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH,




Linkstraße 10 10785 Berlin,




Germany






Atorvastatin 10 mg PD


10 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH,




Linkstraße 10 10785 Berlin,




Germany






Atorvastatin 20 mg PD


20 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH,




Linkstraße 10 10785 Berlin,




Germany






Atorvastatin 40 mg PD


40 mg


Film-coated tablet


Oral use




Germany







Pfizer Pharma GmbH,




Linkstraße 10 10785 Berlin,




Germany






Atorvastatin 80 mg PD


80 mg


Film-coated tablet


Oral use




Greece







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens, Greece






Lipitor


10 mg


Film-coated tablet


Oral use




Greece







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens, Greece






Lipitor


20 mg


Film-coated tablet


Oral use




Greece







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens, Greece






Lipitor


40 mg


Film-coated tablet


Oral use




Greece







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens, Greece






Lipitor


80 mg


Film-coated tablet


Oral use




Greece







WIN MEDICA Ltd




41 Papadiamantopoulou




Street




115 28 Ilisia




Athens, Greece






Zarator


10 mg


Film-coated tablet


Oral use




Greece







WIN MEDICA Ltd




41 Papadiamantopoulou




Street




115 28 Ilisia




Athens, Greece






Zarator


20 mg


Film-coated tablet


Oral use




Greece







WIN MEDICA Ltd




41 Papadiamantopoulou




Street




115 28 Ilisia




Athens, Greece






Zarator


40 mg


Film-coated tablet


Oral use




Greece







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens, Greece






Edovin


10 mg


Film-coated tablet


Oral use




Greece







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens, Greece






Edovin


20 mg


Film-coated tablet


Oral use




Greece







Pfizer Hellas A. E.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens, Greece






Edovin


40 mg


Film-coated tablet


Oral use




Hungary







Pfizer KFT,




1123 Budapest,




Alkotás u. 53. MOM Park ‘F’ Ép.,




Hungary






Sortis


10 mg


Film-coated tablet


Oral use




Hungary







Pfizer KFT,




1123 Budapest,




Alkotás u. 53. MOM Park ‘F’ Ép.,




Hungary






Sortis


20 mg


Film-coated tablet


Oral use




Hungary







Pfizer KFT,




1123 Budapest,




Alkotás u. 53. MOM Park ‘F’ Ép.,




Hungary






Sortis


40 mg


Film-coated tablet


Oral use




Hungary







Pfizer KFT,




1123 Budapest,




Alkotás u. 53. MOM Park ‘F’ Ép.,




Hungary






Sortis


80 mg


Film-coated tablet


Oral use




Hungary







C.P. Pharma Gyógyszerkereskedelmi Kft.




2040 Budaörs




Vasút u. 11.




Hungary






Obradon


10 mg


Film-coated tablet


Oral use




Hungary







C.P. Pharma Gyógyszerkereskedelmi Kft.




2040 Budaörs




Vasút u. 11.




Hungary






Obradon


20 mg


Film-coated tablet


Oral use




Hungary







C.P. Pharma Gyógyszerkereskedelmi Kft.




2040 Budaörs




Vasút u. 11.




Hungary






Obradon


40 mg


Film-coated tablet


Oral use




Hungary







C.P. Pharma Gyógyszerkereskedelmi Kft.




2040 Budaörs




Vasút u. 11.




Hungary






Obradon


80 mg


Film-coated tablet


Oral use




Iceland







Pfizer ApS,




Lautrupvang 8, 2750 Ballerup,




Denmark






Zarator


10 mg


Film-coated tablet


Oral use




Iceland







Pfizer ApS,




Lautrupvang 8, 2750 Ballerup,




Denmark






Zarator


20 mg


Film-coated tablet


Oral use




Iceland







Pfizer ApS,




Lautrupvang 8, 2750 Ballerup,




Denmark






Zarator


40 mg


Film-coated tablet


Oral use




Iceland







Pfizer ApS,




Lautrupvang 8, 2750 Ballerup,




Denmark






Zarator


80 mg


Film-coated tablet


Oral use




Ireland







Pfizer Ireland Pharmaceuticals,




Pottery Road, Dun Laoghaire, Co Dublin




Ireland






Lipitor


10 mg


Film-coated tablet


Oral use




Ireland







Pfizer Ireland Pharmaceuticals,




Pottery Road, Dun Laoghaire, Co Dublin




Ireland






Lipitor


20 mg


Film-coated tablet


Oral use




Ireland







Pfizer Ireland Pharmaceuticals,




Pottery Road, Dun Laoghaire, Co Dublin




Ireland






Lipitor


40 mg


Film-coated tablet


Oral use




Ireland







Pfizer Ireland Pharmaceuticals,




Pottery Road, Dun Laoghaire, Co Dublin




Ireland






Lipitor


80 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina – Italy






Xarator


10 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l. Via Isonzo, 71




04100 Latina – Italy






Xarator


20 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina – Italy






Xarator


40 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina – Italy






Xarator


80 mg


Film-coated tablet


Oral use




Italy







Bioindustria Farmaceutici S.r.l




Via Isonzo, 71




04100 Latina – Italy






Lipitor


10 mg


Film-coated tablet


Oral use




Italy







Bioindustria Farmaceutici S.r.l.




Via Isonzo, 71




04100 Latina – Italy






Lipitor


20 mg


Film-coated tablet


Oral use




Italy







Bioindustria Farmaceutici S.r.l.




Via Isonzo, 71




04100 Latina – Italy






Lipitor


40 mg


Film-coated tablet


Oral use




Italy







Bioindustria Farmaceutici S.r.l.




Via Isonzo, 71




04100 Latina – Italy






Lipitor


80 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina – Italy






Torvast


10 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina – Italy






Torvast


20 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina – Italy






Torvast


40 mg


Film-coated tablet


Oral use




Italy







Pfizer Italia S.r.l.




Via Isonzo, 71




04100 Latina – Italy






Torvast


80 mg


Film-coated tablet


Oral use




Italy







Laboratori Guidotti S.p.A.




Via Livornese, 897 - La Vettola




56010 Pisa – Italy






Totalip


10 mg


Film-coated tablet


Oral use




Italy







Laboratori Guidotti S.p.A.




Via Livornese, 897 - La Vettola




56010 Pisa – Italy






Totalip


20 mg


Film-coated tablet


Oral use




Italy







Laboratori Guidotti S.p.A.




Via Livornese, 897 - La Vettola




56010 Pisa – Italy






Totalip


40 mg


Film-coated tablet


Oral use




Italy







Laboratori Guidotti S.p.A.




Via Livornese, 897 - La Vettola




56010 Pisa – Italy






Totalip


80 mg


Film-coated tablet


Oral use




Latvia







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent CT13 9NJ, United Kingdom






Sortis


10 mg


Film-coated tablet


Oral use




Latvia







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent CT13 9NJ, United Kingdom






Sortis


20 mg


Film-coated tablet


Oral use




Latvia







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent CT13 9NJ, United Kingdom






Sortis


40 mg


Film-coated tablet


Oral use




Latvia







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent CT 13 9NJ, United Kingdom






Sortis


80 mg


Film-coated tablet


Oral use




Lithuania







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent, CT13 9NJ, United Kingdom






Sortis


10 mg


Film-coated tablet


Oral use




Lithuania







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent, CT13 9NJ, United Kingdom






Sortis


20 mg


Film-coated tablet


Oral use




Lithuania







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent, CT13 9NJ, United Kingdom






Sortis


40 mg


Film-coated tablet


Oral use




Lithuania







Pfizer Limited,




Ramsgate Road,




Sandwich, Kent, CT13 9NJ, United Kingdom






Sortis


80 mg


Film-coated tablet


Oral use




Luxembourg







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels,




Belgium






Lipitor


10 mg


Film-coated tablet


Oral use




Luxembourg







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels,




Belgium






Lipitor


20 mg


Film-coated tablet


Oral use




Luxembourg







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels,




Belgium






Lipitor


40 mg


Film-coated tablet


Oral use




Luxembourg







Pfizer SA




Boulevard de la Plaine 17




B-1050 Brussels,




Belgium






Lipitor


80 mg


Film-coated tablet


Oral use




Malta







Pfizer Hellas S.A.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens,




Greece






Lipitor


10 mg


Film-coated tablet


Oral use




Malta







Pfizer Hellas S.A.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens,




Greece






Lipitor


20 mg


Film-coated tablet


Oral use




Malta







Pfizer Hellas S.A.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens,




Greece






Lipitor


40 mg


Film-coated tablet


Oral use




Malta







Pfizer Hellas S.A.




243, Messoghion Ave.,




154 51 Νeo Psychiko, Athens,




Greece






Lipitor


80 mg


Film-coated tablet


Oral use




Netherlands







Pfizer bv




Rivium Westlaan 142




2909 LD Capelle a/d IJssel




The Netherlands






Lipitor


10 mg


Film-coated tablet


Oral use




Netherlands







Pfizer bv




Rivium Westlaan 142




2909 LD Capelle a/d IJssel




The Netherlands






Lipitor


20 mg


Film-coated tablet


Oral use




Netherlands







Pfizer bv




Rivium Westlaan 142




2909 LD Capelle a/d IJssel




The Netherlands






Lipitor


40 mg


Film-coated tablet


Oral use




Netherlands







Pfizer bv




Rivium Westlaan 142




2909 LD Capelle a/d IJssel




The Netherlands






Lipitor


80 mg


Film-coated tablet


Oral use




Norway







Pfizer AS




Pb. 3




1324 Lysaker




Norway






Lipitor


10 mg


Film-coated tablet


Oral use




Norway







Pfizer AS




Pb. 3




1324 Lysaker




Norway






Lipitor


20 mg


Film-coated tablet


Oral use




Norway







Pfizer AS




Pb. 3




1324 Lysaker




Norway






Lipitor


40 mg


Film-coated tablet


Oral use




Norway







Pfizer AS




Pb. 3




1324 Lysaker




Norway






Lipitor


80 mg


Film-coated tablet


Oral use




Poland







Parke-Davis GmbH,




Pfizerstrasse 1,




76 139 Karlsruhe,




Germany






Sortis 10


10 mg


Film-coated tablet


Oral use




Poland







Parke-Davis GmbH,




Pfizerstrasse 1,




76 139 Karlsruhe,




Germany






Sortis 20


20 mg


Film-coated tablet


Oral use




Poland







Parke-Davis GmbH,




Pfizerstrasse 1,




76 139 Karlsruhe,




Germany






Sortis 40


40 mg


Film-coated tablet


Oral use




Poland







Pfizer Polska Sp.z o.o.




ul. Rzymowskiego 28




02-697 Warszawa




Poland






Sortis 80


80 mg


Film-coated tablet


Oral use




Portugal







Laboratorios Pfizer, Lda.,




Lagoas Park, Edifício 10,




2740-271 Porto Salvo, Portugal






Zarator


10 mg


Film-coated tablet


Oral use




Portugal







Laboratorios Pfizer, Lda.,




Lagoas Park, Edifício 10,




2740-271 Porto Salvo, Portugal






Zarator


20 mg


Film-coated tablet


Oral use




Portugal







Laboratorios Pfizer, Lda.,




Lagoas Park, Edifício 10,




2740-271 Porto Salvo, Portugal






Zarator


40 mg


Film-coated tablet


Oral use




Portugal







Laboratorios Pfizer, Lda.,




Lagoas Park, Edifício 10,




2740-271 Porto Salvo, Portugal






Zarator


80 mg


Film-coated tablet


Oral use




Portugal







Parke-Davis - Produtos Farmaceuticos, Lda.,




Lagoas Park, Edifício 10, 2740-271 Porto Salvo,




Portugal






Atorvastatina Parke-Davis


10 mg


Film-coated tablet


Oral use




Portugal







Parke-Davis - Produtos Farmaceuticos, Lda.,




Lagoas Park, Edifício 10, 2740-271 Porto Salvo,




Portugal






Atorvastatina Parke-Davis


20 mg


Film-coated tablet


Oral use




Portugal







Parke-Davis - Produtos Farmaceuticos, Lda.,




Lagoas Park, Edifício 10, 2740-271 Porto Salvo,




Portugal






Atorvastatina Parke-Davis


40 mg


Film-coated tablet


Oral use




Portugal







Parke-Davis - Produtos Farmaceuticos, Lda.,




Lagoas Park, Edifício 10, 2740-271 Porto Salvo,




Portugal






Atorvastatina Parke-Davis


80 mg


Film-coated tablet


Oral use




Portugal







Farmogene - Produtos Farmacêuticos, Lda,




Lagoas Park, Edifício 10, 2740-271 Porto Salvo,




Portugal






Texzor


10 mg


Film-coated tablet


Oral use




Portugal







Farmogene - Produtos Farmacêuticos, Lda,




Lagoas Park, Edifício 10, 2740-271 Porto Salvo,




Portugal






Texzor


20 mg


Film-coated tablet


Oral use




Portugal







Farmogene - Produtos Farmacêuticos, Lda,




Lagoas Park, Edifício 10, 2740-271 Porto Salvo,




Portugal






Texzor


40 mg


Film-coated tablet


Oral use




Portugal







Farmogene - Produtos Farmacêuticos, Lda,




Lagoas Park, Edifício 10, 2740-271 Porto Salvo,




Portugal






Texzor


80 mg


Film-coated tablet


Oral use




Romania







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


10 mg


Film-coated tablet


Oral use




Romania







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


20 mg


Film-coated tablet


Oral use




Romania







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


40 mg


Film-coated tablet


Oral use




Romania







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


80 mg


Film-coated tablet


Oral use




Slovak Republic







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


10 mg


Film-coated tablet


Oral use




Slovak Republic







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


20 mg


Film-coated tablet


Oral use




Slovak Republic







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


40 mg


Film-coated tablet


Oral use




Slovak Republic







Pfizer Europe MA EEIG, Ramsgate Road,




Sandwich,




Kent, CT13 9NJ,




United Kingdom






Sortis


80 mg


Film-coated tablet


Oral use




Slovenia







Pfizer Luxembourg SARL,




51, Avenue J. F. Kennedy, L-1855 Luxembourg,




Luxembourg






Sortis 10 mg filmsko obložene tablete


10 mg


Film-coated tablet


Oral use




Slovenia







Pfizer Luxembourg SARL,




51, Avenue J. F. Kennedy, L-1855 Luxembourg,




Luxembourg






Sortis 20 mg filmsko obložene tablete


20 mg


Film-coated tablet


Oral use




Slovenia







Pfizer Luxembourg SARL,




51, Avenue J. F. Kennedy, L-1855 Luxembourg,




Luxembourg






Sortis 40 mg filmsko obložene tablete


40 mg


Film-coated tablet


Oral use




Slovenia







Pfizer Luxembourg SARL,




51, Avenue J. F. Kennedy, L-1855 Luxembourg,




Luxembourg






Sortis 80 mg filmsko obložene tablete


80 mg


Film-coated tablet


Oral use




Spain







Parke Davis. S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Zarator


10 mg


Film-coated tablet


Oral use




Spain







Parke Davis. S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Zarator


20 mg


Film-coated tablet


Oral use




Spain







Parke Davis. S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Zarator


40 mg


Film-coated tablet


Oral use




Spain







Parke Davis. S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Zarator


80 mg


Film-coated tablet


Oral use




Spain







Pfizer, S.A.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Cardyl


10 mg


Film-coated tablet


Oral use




Spain







Pfizer, S.A.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Cardyl


20 mg


Film-coated tablet


Oral use




Spain







Pfizer, S.A.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Cardyl


40 mg


Film-coated tablet


Oral use




Spain







Pfizer, S.A.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Cardyl


80 mg


Film-coated tablet


Oral use




Spain







Nostrum Farma, S.A., Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Nostrum


10 mg


Film-coated tablet


Oral use




Spain







Nostrum Farma, S.A., Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Nostrum


20 mg


Film-coated tablet


Oral use




Spain







Nostrum Farma, S.A., Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Nostrum


40 mg


Film-coated tablet


Oral use




Spain







Nostrum Farma, S.A., Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Nostrum


80 mg


Film-coated tablet


Oral use




Spain







PHARMACIA GRUPO PFIZER, S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Pharmacia


10 mg


Film-coated tablet


Oral use




Spain







PHARMACIA GRUPO PFIZER, S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Pharmacia


20 mg


Film-coated tablet


Oral use




Spain







PHARMACIA GRUPO PFIZER, S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Pharmacia


40 mg


Film-coated tablet


Oral use




Spain







PHARMACIA GRUPO PFIZER, S.L.




Avda. de Europa 20B




Parque Empresarial la Moraleja




28108 Alcobendas, (Madrid)




Spain






Atorvastatina Pharmacia


80 mg


Film-coated tablet


Oral use




Spain







Almirall S.A.




General Mitre, 151




08022 - Barcelona




Spain






Prevencor


10 mg


Film-coated tablet


Oral use




Spain







Almirall S.A.




General Mitre, 151




08022 - Barcelona




Spain






Prevencor


20 mg


Film-coated tablet


Oral use




Spain







Almirall S.A.




General Mitre, 151




08022 - Barcelona




Spain






Prevencor


40 mg


Film-coated tablet


Oral use




Spain







Almirall S.A.




General Mitre, 151




08022 - Barcelona




Spain






Prevencor


80 mg


Film-coated tablet


Oral use




Sweden







Pfizer AB




191 90 Sollentuna




Sweden






Lipitor


10 mg


Film-coated tablet


Oral use




Sweden







Pfizer AB




191 90 Sollentuna




Sweden






Lipitor


20 mg


Film-coated tablet


Oral use




Sweden







Pfizer AB




191 90 Sollentuna




Sweden






Lipitor


40 mg


Film-coated tablet


Oral use




Sweden







Pfizer AB




191 90 Sollentuna




Sweden






Lipitor


80 mg


Film-coated tablet


Oral use




United Kingdom







Pfizer Ireland Pharmaceuticals,




Pottery Road, Dun Laoghaire, Co Dublin




Ireland






Lipitor


10 mg


Film-coated tablet


Oral use




United Kingdom







Pfizer Ireland Pharmaceuticals,




Pottery Road, Dun Laoghaire, Co Dublin




Ireland






Lipitor


20 mg


Film-coated tablet


Oral use




United Kingdom







Pfizer Ireland Pharmaceuticals,




Pottery Road, Dun Laoghaire, Co Dublin




Ireland






Lipitor


40 mg


Film-coated tablet


Oral use




United Kingdom







Pfizer Ireland Pharmaceuticals,




Pottery Road, Dun Laoghaire, Co Dublin Ireland






Lipitor


80 mg


Film-coated tablet


Oral use







ANNEX XI

SCIENTIFIC CONCLUSIONS AND GROUNDS FOR AMENDMENT OF THE SUMMARY OF PRODUCT CHARACTERISTICS AND PACKAGE LEAFLET

All veterinary medicinal products for food producing species containing quinolones and/or fluoroquinolones as active substances.



ANNEX XII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER(S) IN THE MEMBER STATES











Member State


Marketing Authorisation Holder


Invented name


Strength


Pharmaceutical Form


Route of administration




Austria







AstraZeneca Österreich GmbH




Schwarzenbergplatz 7




A-1037 Wien




Austria






Seroquel XR 50 mg – Retardtabletten


50 mg


Prolonged-release tablet


Oral use




Austria







AstraZeneca Österreich GmbH




Schwarzenbergplatz 7




A-1037 Wien




Austria






Seroquel XR 150 mg – Retardtabletten


150 mg


Prolonged-release tablet


Oral use




Austria







AstraZeneca Österreich GmbH




Schwarzenbergplatz 7




A-1037 Wien




Austria






Seroquel XR 200 mg – Retardtabletten


200 mg


Prolonged-release tablet


Oral use




Austria







AstraZeneca Österreich GmbH




Schwarzenbergplatz 7




A-1037 Wien




Austria






Seroquel XR 300 mg – Retardtabletten


300 mg


Prolonged-release tablet


Oral use




Austria







AstraZeneca Österreich GmbH




Schwarzenbergplatz 7




A-1037 Wien




Austria






Seroquel XR 400 mg – Retardtabletten


400 mg


Prolonged-release tablet


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussel




Belgium






Seroquel XR 50 mg prolonged-release tablets


50 mg


Prolonged-release tablet


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussel




Belgium






Seroquel XR 150 mg prolonged-release tablets


150 mg


Prolonged-release tablet


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussel




Belgium






Seroquel XR 200 mg prolonged-release tablets


200 mg


Prolonged-release tablet


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussel




Belgium






Seroquel XR 300 mg prolonged-release tablets


300 mg


Prolonged-release tablet


Oral use




Belgium







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussel




Belgium






Seroquel XR 400 mg prolonged-release tablets


400 mg


Prolonged-release tablet


Oral use




Cyprus







AstraZeneca UK Limited,




Silk Road Business Park,




Macclesfield, Cheshire, SK10 2NA,




United Kingdom






Seroquel XR 50 mg prolonged-release tablets


50 mg


Prolonged-release tablet


Oral use




Cyprus







AstraZeneca UK Limited,




Silk Road Business Park,




Macclesfield, Cheshire, SK10 2NA,




United Kingdom






Seroquel XR 200 mg prolonged-release tablets


200 mg


Prolonged-release tablet


Oral use




Cyprus







AstraZeneca UK Limited,




Silk Road Business Park,




Macclesfield, Cheshire, SK10 2NA,




United Kingdom






Seroquel XR 300 mg prolonged-release tablets


300 mg


Prolonged-release tablet


Oral use




Cyprus







AstraZeneca UK Limited,




Silk Road Business Park,




Macclesfield, Cheshire, SK10 2NA,




United Kingdom






Seroquel XR 400 mg prolonged-release tablets


400 mg


Prolonged-release tablet


Oral use




Germany







AstraZeneca GmbH,




Tinsdaler Weg 183,




22880 Wedel,




Germany






Seroquel Prolong 50 mg Retardtabletten


50 mg


Prolonged-release tablet


Oral use




Germany







AstraZeneca GmbH,




Tinsdaler Weg 183,




22880 Wedel,




Germany






Seroquel Prolong 150 mg Retardtabletten


150 mg


Prolonged-release tablet


Oral use




Germany







AstraZeneca GmbH,




Tinsdaler Weg 183,




22880 Wedel,




Germany






Seroquel Prolong 200 mg Retardtabletten


200 mg


Prolonged-release tablet


Oral use




Germany







AstraZeneca GmbH,




Tinsdaler Weg 183,




22880 Wedel,




Germany






Seroquel Prolong 300 mg Retardtabletten


300 mg


Prolonged-release tablet


Oral use




Germany







AstraZeneca GmbH,




Tinsdaler Weg 183,




22880 Wedel,




Germany






Seroquel Prolong 400 mg Retardtabletten


400 mg


Prolonged-release tablet


Oral use




Denmark







AstraZeneca A/S




Roskildevej 22




2620 Albertslund




Denmark






Seroquel Prolong 50 mg prolonged-release tablets


50 mg


Prolonged-release tablet


Oral use




Denmark







AstraZeneca A/S




Roskildevej 22




2620 Albertslund




Denmark






Seroquel Prolong 150 mg prolonged-release tablets


150 mg


Prolonged-release tablet


Oral use




Denmark







AstraZeneca A/S




Roskildevej 22




2620 Albertslund




Denmark






Seroquel Prolong 200 mg prolonged-release tablets


200 mg


Prolonged-release tablet


Oral use




Denmark







AstraZeneca A/S




Roskildevej 22




2620 Albertslund




Denmark






Seroquel Prolong 300 mg prolonged-release tablets


300 mg


Prolonged-release tablet


Oral use




Denmark







AstraZeneca A/S




Roskildevej 22




2620 Albertslund




Denmark






Seroquel Prolong 400 mg prolonged-release tablets


400 mg


Prolonged-release tablet


Oral use




Greece







AstraZeneca S.A.




4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens




Greece






Seroquel XR 50 mg


50 mg


Prolonged-release tablet


Oral use




Greece







AstraZeneca S.A.




4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens




Greece






Seroquel XR 150 mg


150 mg


Prolonged-release tablet


Oral use




Greece







AstraZeneca S.A.




4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens




Greece






Seroquel XR 200 mg


200 mg


Prolonged-release tablet


Oral use




Greece







AstraZeneca S.A.




4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens




Greece






Seroquel XR 300 mg


300 mg


Prolonged-release tablet


Oral use




Greece







AstraZeneca S.A.




4 Theotokopoulou & Astronafton 151 25 Maroussi, Athens




Greece






Seroquel XR 400 mg


400 mg


Prolonged-release tablet


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




C/ Serrano Galvache, 56 – Edificio Roble




28033 Madrid




Spain






Seroquel Prolong 50 mg comprimidos de liberación prolongada


50 mg


Prolonged-release tablet


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




C/ Serrano Galvache, 56 – Edificio Roble




28033 Madrid




Spain






Seroquel Prolong 150 mg comprimidos de liberación prolongada


150 mg


Prolonged-release tablet


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




C/ Serrano Galvache, 56 – Edificio Roble




28033 Madrid




Spain






Seroquel Prolong 200 mg comprimidos de liberación prolongada


200 mg


Prolonged-release tablet


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




C/ Serrano Galvache, 56 – Edificio Roble




28033 Madrid




Spain






Seroquel Prolong 300 mg comprimidos de liberación prolongada


300 mg


Prolonged-release tablet


Oral use




Spain







AstraZeneca Farmacéutica Spain, S.A.




C/ Serrano Galvache, 56 – Edificio Roble




28033 Madrid




Spain






Seroquel Prolong 400 mg comprimidos de liberación prolongada


400 mg


Prolonged-release tablet


Oral use




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Seroquel Prolong 50 mg depottabletti


50 mg


Prolonged-release tablet


Oral use




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Seroquel Prolong 150 mg depottabletti


150 mg


Prolonged-release tablet


Oral use




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Seroquel Prolong 200 mg depottabletti


200 mg


Prolonged-release tablet


Oral use




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Seroquel Prolong 300 mg depottabletti


300 mg


Prolonged-release tablet


Oral use




Finland







AstraZeneca Oy




Luomanportti 3




FI-02200 Espoo




Finland






Seroquel Prolong 400 mg depottabletti


400 mg


Prolonged-release tablet


Oral use




Iceland







AstraZeneca A/S




Roskildevej 22




2620 Albertslund




Denmark






Seroquel Prolong


50 mg


Prolonged-release tablet


Oral use




Iceland







AstraZeneca A/S




Roskildevej 22




2620 Albertslund




Denmark






Seroquel Prolong


150 mg


Prolonged-release tablet


Oral use




Iceland







AstraZeneca A/S




Roskildevej 22




2620 Albertslund




Denmark






Seroquel Prolong


200 mg


Prolonged-release tablet


Oral use




Iceland







AstraZeneca A/S




Roskildevej 22




2620 Albertslund




Denmark






Seroquel Prolong


300 mg


Prolonged-release tablet


Oral use




Iceland







AstraZeneca A/S




Roskildevej 22




2620 Albertslund




Denmark






Seroquel Prolong


400 mg


Prolonged-release tablet


Oral use




Ireland







AstraZeneca UK Ltd




600 Capability Green




Luton LU1 3LU




United Kingdom






Seroquel XR 50 mg prolonged-release tablets


50 mg


Prolonged-release tablet


Oral use




Ireland







AstraZeneca UK Ltd




600 Capability Green




Luton LU1 3LU




United Kingdom






Seroquel XR 150 mg prolonged-release tablets


150 mg


Prolonged-release tablet


Oral use




Ireland







AstraZeneca UK Ltd




600 Capability Green




Luton LU1 3LU




United Kingdom






Seroquel XR 200 mg prolonged-release tablets


200 mg


Prolonged-release tablet


Oral use




Ireland







AstraZeneca UK Ltd




600 Capability Green




Luton LU1 3LU




United Kingdom






Seroquel XR 300 mg prolonged-release tablets


300 mg


Prolonged-release tablet


Oral use




Ireland







AstraZeneca UK Ltd




600 Capability Green




Luton LU1 3LU




United Kingdom






Seroquel XR 400 mg prolonged-release tablets


400 mg


Prolonged-release tablet


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussel




Belgium






Seroquel XR 50 mg prolonged-release tablets


50 mg


Prolonged-release tablet


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussel




Belgium






Seroquel XR 150 mg prolonged-release tablets


150 mg


Prolonged-release tablet


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussel




Belgium






Seroquel XR 200 mg prolonged-release tablets


200 mg


Prolonged-release tablet


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussel




Belgium






Seroquel XR 300 mg prolonged-release tablets


300 mg


Prolonged-release tablet


Oral use




Luxembourg







NV AstraZeneca SA




Egide Van Ophemstraat 110




B-1180 Brussel




Belgium






Seroquel XR 400 mg prolonged-release tablets


400 mg


Prolonged-release tablet


Oral use




Malta







AstraZeneca UK Ltd




Silk Road Business Park




Macclesfield




Cheshire SK10 2NA




United Kingdom






Seroquel XR 50 mg prolonged-release tablets


50 mg


Prolonged-release tablet


Oral use




Malta







AstraZeneca UK Ltd




Silk Road Business Park




Macclesfield




Cheshire SK10 2NA




United Kingdom






Seroquel XR 150 mg prolonged-release tablets


150 mg


Prolonged-release tablet


Oral use




Malta







AstraZeneca UK Ltd




Silk Road Business Park




Macclesfield




Cheshire SK10 2NA




United Kingdom






Seroquel XR 200 mg prolonged-release tablets


200 mg


Prolonged-release tablet


Oral use




Malta







AstraZeneca UK Ltd




Silk Road Business Park




Macclesfield




Cheshire SK10 2NA




United Kingdom






Seroquel XR 300 mg prolonged-release tablets


300 mg


Prolonged-release tablet


Oral use




Malta







AstraZeneca UK Ltd




Silk Road Business Park




Macclesfield




Cheshire SK10 2NA




United Kingdom






Seroquel XR 400 mg prolonged-release tablets


400 mg


Prolonged-release tablet


Oral use




Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Seroquel XR 50 mg prolonged-release tablets


50 mg


Prolonged-release tablet


Oral use




Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Seroquel XR 150 mg prolonged-release tablets


150 mg


Prolonged-release tablet


Oral use




Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Seroquel XR 200 mg prolonged-release tablets


200 mg


Prolonged-release tablet


Oral use




Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Seroquel XR 300 mg prolonged-release tablets


300 mg


Prolonged-release tablet


Oral use




Netherlands







AstraZeneca BV




Louis Pasteurlaan 5




2719 EE Zoetermeer




The Netherlands






Seroquel XR 400 mg prolonged-release tablets


400 mg


Prolonged-release tablet


Oral use




Norway







AstraZeneca AS,




Hoffsveien 70B,




(PO Box 200),




0319 Oslo, Norway






Seroquel Depot 50 mg depottabletter


50 mg


Prolonged-release tablet


Oral use




Norway







AstraZeneca AS,




Hoffsveien 70B,




(PO Box 200),




0319 Oslo, Norway






Seroquel Depot 150 mg depottabletter


150 mg


Prolonged-release tablet


Oral use




Norway







AstraZeneca AS,




Hoffsveien 70B,




(PO Box 200),




0319 Oslo, Norway






Seroquel Depot 200 mg depottabletter


200 mg


Prolonged-release tablet


Oral use




Norway







AstraZeneca AS,




Hoffsveien 70B,




(PO Box 200),




0319 Oslo, Norway






Seroquel Depot 300 mg depotabletter


300 mg


Prolonged-release tablet


Oral use




Norway







AstraZeneca AS,




Hoffsveien 70B,




(PO Box 200),




0319 Oslo, Norway






Seroquel Depot 400 mg depottabletter


400 mg


Prolonged-release tablet


Oral use




Poland







AstraZeneca UK Limited,




15 Stanhope Gate,




London




W1K 1LN, UK






Seroquel XR


50 mg


Prolonged-release tablet


Oral use




Poland







AstraZeneca UK Limited,




15 Stanhope Gate,




London




W1K 1LN, UK






Seroquel XR


150 mg


Prolonged-release tablet


Oral use




Poland







AstraZeneca UK Limited,




15 Stanhope Gate,




London




W1K 1LN, UK






Seroquel XR


200 mg


Prolonged-release tablet


Oral use




Poland







AstraZeneca UK Limited,




15 Stanhope Gate,




London




W1K 1LN, UK






Seroquel XR


300 mg


Prolonged-release tablet


Oral use




Poland







AstraZeneca UK Limited,




15 Stanhope Gate,




London




W1K 1LN, UK






Seroquel XR


400 mg


Prolonged-release tablet


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7




Valejas




2745-663 Barcarena




Portugal






Seroquel SR


50 mg


Prolonged-release tablet


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7




Valejas




2745-663 Barcarena




Portugal






Seroquel SR


150 mg


Prolonged-release tablet


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7




Valejas




2745-663 Barcarena




Portugal






Seroquel SR


200 mg


Prolonged-release tablet


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7




Valejas




2745-663 Barcarena




Portugal






Seroquel SR


300 mg


Prolonged-release tablet


Oral use




Portugal







AstraZeneca Produtos Farmacêuticos, Lda.




Rua Humberto Madeira, 7




Valejas




2745-663 Barcarena




Portugal






Seroquel SR


400 mg


Prolonged-release tablet


Oral use




Sweden







AstraZeneca AB




AstraZeneca Sverige




SE-151 85 Södertälje




Sweden






Seroquel Depot 50 mg depottabletter


50 mg


Prolonged-release tablet


Oral use




Sweden







AstraZeneca AB




AstraZeneca Sverige




SE-151 85 Södertälje




Sweden






Seroquel Depot 150 mg depottabletter


150 mg


Prolonged-release tablet


Oral use




Sweden







AstraZeneca AB




AstraZeneca Sverige




SE-151 85 Södertälje




Sweden






Seroquel Depot 200 mg depottabletter


200 mg


Prolonged-release tablet


Oral use




Sweden







AstraZeneca AB




AstraZeneca Sverige




SE-151 85 Södertälje




Sweden






Seroquel Depot 300 mg depottabletter


300 mg


Prolonged-release tablet


Oral use




Sweden







AstraZeneca AB




AstraZeneca Sverige




SE-151 85 Södertälje




Sweden






Seroquel Depot 400 mg depottabletter


400 mg


Prolonged-release tablet


Oral use







ANNEX XIII

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE VETERINARY MEDICINAL PRODUCTS, ANIMAL SPECIES, ROUTE OF ADMINISTRATION, MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State/EEA


Marketing Authorisation Holder


Invented name


Pharmaceutical form


Strength


Animal species


Route of administration




Austria







Novartis Animal Health GmbH.,




Biochemiestrasse 10,




6250 Kundl




AUSTRIA






Denagard Novartis 100 g/kg Arzneimittelvormischung zur Herstellung von Fütterungsarzneimitteln für Schweine


Premix


100 g/kg


Pigs


Oral




Austria







Novartis Animal Health GmbH.,




Biochemiestrasse 10,




6250 Kundl




AUSTRIA






Denagard Novartis 20 g/kg Arzneimittelvormischung zur Herstellung von Fütterungsarzneimitteln für Schweine


Premix


20 g/kg


Pigs


Oral




Austria







Novartis Animal Health GmbH.,




Biochemiestrasse 10,




6250 Kundl




AUSTRIA






Tiamutin 20 g/kg Arzneimittelvormischung zur Herstellung von Fütterungsarzneimitteln für Schweine


Premix


20 g/kg


Pigs


Oral




Belgium







VMD nv




Leo Aerden




Hoge Mauw 900,




2370 Arendonk




BELGIUM






Tiamutin 10 % gemedicineerd voormengsel


Premix


100 mg/g


Pigs


Oral




Cyprus







Novartis Animal Health Inc.,




Basle,




SWITZERLAND






Denagard 10 %


Premix


100 mg/g


Pigs


Oral




Czech Republic







Novartis Animal Health d.o.o., Verovškova 57,




1000 Ljubljana




SLOVENIA






Tiamutin 10 % premix ad us.vet.


Premix


100 mg/g


Pigs
Chickens
Turkeys


Oral




Czech Republic







Novartis Animal Health d.o.o., Verovškova 57,




1000 Ljubljana




SLOVENIA






Tiamutin 2 % premix ad us.vet.


Premix


20 mg/g


Pigs
Chickens
Turkeys


Oral




France







Novartis Sante Animale




14 Boulevard Richelieu




92500 Rueil Malmaison




FRANCE






Denagard prémélange tiamuline 16,2 pneumonie volaille - porc


Premix


16,2 mg/g


Pigs
Turkeys
Chickens


Oral




France







Novartis Sante Animale




14 Boulevard Richelieu




92500 Rueil Malmaison




FRANCE






Denagard prémélange tiamuline 6,5 enterite porc enterocolite lapin


Premix


6,5 mg/g


Rabbits
Pigs


Oral




Germany







Novartis Tiergesundheit GmbH




Zielstattstr. 40,




81379 München




GERMANY






Denagard 10 % AMV


Premix


100 g/kg


Pigs


Oral




Greece







Premier Shukuroglou Hellas S.A




Mesogion Av 198,




15561 Holargos




GREECE






Denagard 2 %


Premix


20 mg/g


Pigs


Oral




Greece







Premier Shukuroglou Hellas S.A




Mesogion Av 198,




15561 Holargos




GREECE






Denagard 10 %


Premix


100 mg/g


Pigs


Oral




Hungary







Novartis Animal Health d.o.o.




Verovskova 57,




1000 Ljubljana




SLOVENIA






Denagard 10 % gyógypremix A.U.V.


Premix


100 mg/g


Pigs


Oral




Ireland







Novartis Animal Health Ireland Ltd.,




Industrial Park,




Cork Road,




Waterford




IRELAND






Tiamutin 2 %


Premix


20 mg/g


Pigs


Oral




Ireland







Novartis Animal Health Ireland Ltd.,




Industrial Park,




Cork Road,




Waterford




IRELAND






Tiamutin 80 %


Premix


800 mg/g


Pigs


Oral




Italy







Novartis Animal Health S.P.A




Largo Umberto Boccioni, 1




21040 Origlio (Varese)




ITALY






Denagard 10 % Premix


Premix


100 mg/g


Pigs
Chickens
Turkeys


Oral




Italy







Novartis Animal Health S.P.A




Largo Umberto Boccioni, 1




21040 Origlio (Varese)




ITALY






Denagard 10 % Premix Plus


Premix


100 mg/g


Pigs


Oral




Latvia







Novartis Animal Health d.o.o.




Verovškova 57,




1000 Ljubljana




SLOVENIA






Tiamutin 10 % premix


Premix


100 mg/g


Pigs


Oral




Lithuania







Novartis Animal Health d.o.o.




Verovškova 57,




1000 Ljubljana




SLOVENIA






Tiamutin 10 % vaistinis premiksas kiaulėms


Premix


100 mg/g


Pigs


Oral




Portugal







Novartis Farma Produtos Farmacêuticos S.A




Rua do Centro Empresarial




Edifício 8




Quinta da Beloura




2710-444 Sintra




PORTUGAL






Denagard 20 g/Kg


Premix


20 g/kg


Pigs
Chickens
Turkeys


Oral




Portugal







Novartis Farma Produtos Farmacêuticos S.A




Rua do Centro Empresarial




Edifício 8




Quinta da Beloura




2710-444 Sintra




PORTUGAL






Denagard 100 g/Kg


Premix


100 g/kg


Pigs
Chickens
Turkeys
Rabbits


Oral




Portugal







Novartis Farma Produtos Farmacêuticos S.A




Rua do Centro Empresarial




Edifício 8




Quinta da Beloura




2710-444 Sintra




PORTUGAL






Dynamutilin 100 g/Kg


Premix


100 g/kg


Pigs
Chickens
Turkeys


Oral




Poland







Novartis Animal Health d.o.o.




Verovškova 57,




1000 Ljubljana




SLOVENIA






Tiamutin 10 % premiks leczniczy dla świń


Premix


100 mg/g


Pigs


Oral




Poland







Novartis Animal Health d.o.o.




Verovškova 57,




1000 Ljubljana




SLOVENIA






Tiamutin 2 % 20 mg/g premiks do sporządzania paszy leczniczej dla świń


Premix


20 mg/g


Pigs


Oral




Romania







Novartis Animal Health d.o.o.




Verovškova 57,




1000 Ljubljana




SLOVENIA






Tiamutin 10 % Premix pentru furaje medicamentate pentru porci


Premix


100 mg/g


Pigs
Chickens
Turkeys


Oral




Romania







Novartis Animal Health d.o.o.




Verovškova 57,




SI-1000 Ljubljana




SLOVENIA






Tiamutin 80 % coated


Premix


800 g/100 kg


Pigs
Chickens
Turkeys


Oral




Slovakia







Novartis Animal Health d.o.o.




Verovškova 57,




1000 Ljubljana




SLOVENIA






Tiamutin 10 % prm. ad us. vet.


Premix


100 mg/g


Pigs
Chickens
Turkeys


Oral




Slovakia







Novartis Animal Health d.o.o.




Verovškova 57,




1000 Ljubljana




SLOVENIA






Tiamutin 2 % prm. ad us. vet.


Premix


20 mg/g


Pigs
Chickens
Turkeys


Oral




Spain







Novartis Sanidad Animal, S.L.




c/De la Marina, 206




08013 Barcelona




SPAIN






Denagard 100 g/kg Premezcla medicamentosa


Premix


100 g/kg


Pigs
Chickens
Turkeys
Rabbits


Oral




Spain







Novartis Sanidad Animal, S.L.




c/De la Marina, 206




08013 Barcelona




SPAIN






Denagard 20 g/kg Premezcla medicamentosa


Premix


20 g/kg


Pigs
Rabbits


Oral




Spain







Novartis Sanidad Animal, S.L.




c/De la Marina, 206




08013 Barcelona




SPAIN






Dynamutilin 10 %


Premix


100 g/kg


Pigs
Chickens
Turkeys


Oral




Sweden







Novartis Healthcare A/S




Animal Health




Lyngbyvej 172




DK-2100 Köpenhamn Ö




DENMARK






Denagard vet.


Premix


20 mg/g


Pigs


Oral




The Netherlands







Novartis Consumer health




Claudius Prinsenlaan 142




4818 CP Breda




The NETHERLANDS






Tiamutin 10 %


Premix


100 g/kg


Pigs


Oral




The Netherlands







Novartis Consumer health




Claudius Prinsenlaan 142




4818 CP Breda




The NETHERLANDS






Denagard 2 %


Premix


20 g/kg


Pigs


Oral




United Kingdom







Novartis Animal Health UK Ltd




Frimley Business Park




Frimley




Camberley




Surrey




GU16 7SR




United Kingdom






Denagard 2 % w/w


Premix


2 mg/g


Pigs


Oral




United Kingdom







Novartis Animal Health UK Ltd




Frimley Business Park




Frimley




Camberley




Surrey




GU16 7SR




United Kingdom






Denagard 80 % w/w


Premix


80 mg/g


Pigs


Oral




United Kingdom







Novartis Animal Health UK Ltd




Frimley Business Park




Frimley




Camberley




Surrey




GU16 7SR




United Kingdom






Denagard 10 % w/w


Premix


100 mg/g


Pigs


Oral







ANNEX XIV

LIST OF THE NAMES, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANT/MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES












Member State EU/EEA


Marketing Authorisation Holder


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of administration




Belgium


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciclosporin IDL 25 mg


25 mg


capsule


oral use




Belgium


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciclosporin IDL 50 mg


50 mg


capsule


oral use




Belgium


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciclosporin IDL 100 mg


100 mg


capsule


oral use




Germany


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciclosporin IDL 25 mg


25 mg


capsule


oral use




Germany


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciclosporin IDL 50 mg


50 mg


capsule


oral use




Germany


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciclosporin IDL 100 mg


100 mg


capsule


oral use




Italy


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciclosporina IDL 25 mg


25 mg


capsule


oral use




Italy


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciclosporina IDL 50 mg


50 mg


capsule


oral use




Italy


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciclosporina IDL 100 mg


100 mg


capsule


oral use




Netherlands







IDL, 36 avenue Hoche




75008 Paris. FRANCE






 


Ciclosporin IDL 25 mg


25 mg


capsule, soft


oral use




Netherlands







IDL, 36 avenue Hoche




75008 Paris. FRANCE






 


Ciclosporin IDL 50 mg


50 mg


capsule, soft


oral use




Netherlands







IDL, 36 avenue Hoche




75008 Paris. FRANCE






 


Ciclosporin IDL 100 mg


100 mg


capsule, soft


oral use




Spain


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciclosporina IDL 25 mg


25 mg


capsule


oral use




Spain


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciclosporina IDL 50 mg


50 mg


capsule


oral use




Spain


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciclosporina IDL 100 mg


100 mg


capsule


oral use




Sweden


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciklosporin IDL 25 mg


25 mg


capsule


oral use




Sweden


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciklosporin IDL 50 mg


50 mg


capsule


oral use




Sweden


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciklosporin IDL 100 mg


100 mg


capsule


oral use




United Kingdom


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciclosporin IDL 25 mg


25 mg


capsule


oral use




United Kingdom


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciclosporin IDL 50 mg


50 mg


capsule


oral use




United Kingdom


 







IDL, 36 avenue Hoche,




75008 Paris. FRANCE






Ciclosporin IDL 100 mg


100 mg


capsule


oral use







ANNEX XV

LIST OF THE INVENTED NAME, PHARMACEUTICAL FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EU/EEA)











Member State EU/EEA


Marketing Authorisation Holder


Invented Name


Strength


Pharmaceutical form


Route of administration




Austria







Abbott GmbH




Perfektastraße 84A




A-1230 Wien




Austria






Reductil 10 mg - Hartkapseln


10 mg


Capsule, hard


oral use




Austria







Abott GmbH




Perfektastraße 84A




A-1230 Wien




Austria






Reductil 15 mg - Hartkapseln


15 mg


Capsule, hard


oral use




Austria







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






Sibutramin Teva 10 mg Kapseln


10 mg


Capsule, hard


oral use




Austria







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






Sibutramin Teva 15 mg Kapseln


15 mg


Capsule, hard


oral use




Belgium







Abbott SA




rue du Bosquet 2




1348 Ottignies/LLN




Belgium






Reductil 10 mg


10 mg


Capsule, hard


oral use




Belgium







Abbott SA




rue du Bosquet 2




1348 Ottignies/LLN




Belgium






Reductil 15 mg


15 mg


Capsule, hard


oral use




Belgium







Sandoz NV




Telecom Gardens




Medialaan 40




1800 Vilvoorde




Belgium






Sibutramin Sandoz 10 mg


10 mg


Capsule, hard


oral use




Belgium







Sandoz NV




Telecom Gardens




Medialaan 40




1800 Vilvoorde




Belgium






Sibutramin Sandoz 15 mg


15 mg


Capsule, hard


oral use




Belgium







Teva pharma belgium




Laarstraat 16




2610 Wilrijk




Belgium






Sibutramin Teva 10 mg


10 mg


Capsule, hard


oral use




Belgium







Teva pharma belgium




Laarstraat 16




2610 Wilrijk




Belgium






Sibutramin Teva 15 mg


15 mg


Capsule, hard


oral use




Bulgaria







Abbott GmbH & Co KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






Reductil


10 mg


Capsule, hard


oral use




Bulgaria







Abbott GmbH & Co KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






Reductil


15 mg


Capsule, hard


oral use




Bulgaria







Sandoz d.d.,




Verovskova 57




SI - 1000 Ljubljana




Slovenia






Sibutramin Sandoz


10 mg


Capsule, hard


oral use




Bulgaria







Sandoz d.d.




Verovskova 57




SI - 1000 Ljubljana




Slovenia






Sibutramin Sandoz


15 mg


Capsule, hard


oral use




Bulgaria







Zentiva k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Lindaxa


10 mg


Capsule, hard


oral use




Bulgaria







Zentiva k.s.




U kabelovny 130




102 37 Prague 10




Czech Republic






Lindaxa


15 mg


Capsule, hard


oral use




Bulgaria







Teva Pharmaceuticals Bulgaria EOOD




15 N.V. Gogol str.




Sredetz district




1124 Sofia




Bulgaria






Meissa


10 mg


Capsule, hard


oral use




Bulgaria







Teva Pharmaceuticals Bulgaria EOOD




15 N.V. Gogol str.




Sredetz district




1124 Sofia




Bulgaria






Meissa


15 mg


Capsule, hard


oral use




Czech Republic







Abbott GmbH &Co.KG




Max-Planck-Ring-2




65202 Wiesbaden




Germany






MERIDIA 10 MG


10 mg


Capsule, hard


oral use




Czech Republic







Abbott GmbH &Co.KG




Max-Planck-Ring-2




65202 Wiesbaden




Germany






MERIDIA 15 MG


15 mg


Capsule, hard


oral use




Czech Republic







Zentiva, k.s.




U kabelovny 130, 102 37




Prague 10




Czech Republic






LINDAXA 10


10 mg


Capsule, hard


oral use




Czech Republic







Zentiva, k.s.




U kabelovny 130, 102 37




Prague 10




Czech Republic






LINDAXA 15


15 mg


Capsule, hard


oral use




Czech Republic







TEVA Pharmaceuticals ČR, s.r.o.




Radlická 3185/Ic




150 00 Prague 5




Czech Republic






SIBUTRAMIN-TEVA 10 MG TOBOLKY


10 mg


Capsule, hard


oral use




Czech Republic







TEVA Pharmaceuticals ČR, s.r.o.




Radlická 3185/Ic




150 00 Prague 5




Czech Republic






SIBUTRAMIN-TEVA 15 MG TOBOLKY


15 mg


Capsule, hard


oral use




Denmark







Abbott Scandinavia AB




Postboks 509




SE-169 29, Solna




Sweden






Reductil


10 mg


Capsule, hard


oral use




Denmark







Abbott Scandinavia AB




Postboks 509




SE-169 29, Solna




Sweden






Reductil


15 mg


Capsule, hard


oral use




Denmark







1A Farma A/S




Herstedøstervej 27-29




DK-2620 Albertslund




Denmark






Sibutramin ‘1A Farma’


10 mg


Capsule, hard


oral use




Denmark







1A Farma A/S




Herstedøstervej 27-29




DK-2620 Albertslund




Denmark






Sibutramin ‘1A Farma’


15 mg


Capsule, hard


oral use




Denmark







Sandoz A/S




C. F. Tietgens Boulevard 40




DK-5220 Odense SØ




Denmark






Sibutramin ‘Sandoz’


10 mg


Capsule, hard


oral use




Denmark







Sandoz A/S




C. F. Tietgens Boulevard 40




DK-5220 Odense SØ




Denmark






Sibutramin ‘Sandoz’


15 mg


Capsule, hard


oral use




Denmark







Teva Danmark A/S




Østergade 38




DK-1100 København K




Denmark






Sibutramin ‘Teva’


10 mg


Capsule, hard


oral use




Denmark







Teva Danmark A/S




Østergade 38




DK-1100 København K




Denmark






Sibutramin ‘Teva’


15 mg


Capsule, hard


oral use




Estonia







Abbott GmbH & Co. KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






REDUCTIL


10 mg


Capsule, hard


oral use




Estonia







Abbott GmbH & Co. KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






REDUCTIL


15 mg


Capsule, hard


oral use




Estonia







Sandoz d.d.




Verovskova 57




1000 Ljubljana




Slovenia






SIBUTRIL


10 mg


Capsule, hard


oral use




Estonia







Sandoz d.d.




Verovskova 57




1000 Ljubljana




Slovenia






SIBUTRIL


15 mg


Capsule, hard


oral use




Estonia







Zentiva, k.s.




U Kabelovny 130




Dolni Mecholupy




102 37 Prague 10




Czech Republic






LINDAXA 10


10 mg


Capsule, hard


oral use




Estonia







Zentiva, k.s.




U Kabelovny 130




Dolni Mecholupy




102 37 Prague 10




Czech Republic






LINDAXA 15


15 mg


Capsule, hard


oral use




Estonia







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






SIBUTRAMINE TEVA


10 mg


Capsule, hard


oral use




Estonia







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






SIBUTRAMINE TEVA


15 mg


Capsule, hard


oral use




Finland







Abbott Scandinavia AB




P.O. Box 509




16929 Solna




Sweden






Reductil


10 mg, 15 mg


Capsule, hard


oral use




Finland







Sandoz A/S C.F.




Tietgens Boulevard 40




5220 Odense SØ




Denmark






Sibutramin Sandoz


10 mg, 15 mg


Capsule, hard


oral use




Finland







Teva Sweden AB




Järnvägsgatan 11




Box 1070




25110 Helsingborg




Sweden






Sibutramine Teva


10 mg, 15 mg


Capsule, hard


oral use




France







ABBOT France




10, RUE D'ARCUEIL




SILIC 233




94528 RUNGIS CEDEX




FRANCE






SIBUTRAL 10 mg, gélule


10 mg


capsule


oral use




France







ABBOT France




10, RUE D'ARCUEIL




SILIC 233




94528 RUNGIS CEDEX




FRANCE






SIBUTRAL 15 mg, gélule


15 mg


capsule


oral use




Germany







Abbott GmbH & Co. KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






Reductil 10 mg Hartkapseln


10 mg


Capsule, hard


oral use




Germany







Abbott GmbH & Co. KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






Reductil 15 mg Hartkapseln


15 mg


Capsule, hard


oral use




Germany







Abbott GmbH & Co. KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






Zelium 10 mg Hartkapseln


10 mg


Capsule, hard


oral use




Germany







Abbott GmbH & Co. KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






Zelium 15 mg Hartkapseln


15 mg


Capsule, hard


oral use




Germany







Abbott GmbH & Co. KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






Reduxade 10 mg Hartkapseln


10 mg


Capsule, hard


oral use




Germany







Abbott GmbH & Co. KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






Reduxade 15 mg Hartkapseln


15 mg


Capsule, hard


oral use




Germany







1 A Pharma GmbH




Keltenring 1 + 3




82041 Oberhaching




Germany






Sibutramin - 1A Pharma 10 mg Hartkapseln


10 mg


Capsule, hard


oral use




Germany







1 A Pharma GmbH




Keltenring 1 + 3




82041 Oberhaching




Germany






Sibutramin - 1A Pharma 15 mg Hartkapseln


15 mg


Capsule, hard


oral use




Germany







HEXAL AG




Postfach 1263




83602 Holzkirchen




Germany






Sibutramin-HEXAL 10 mg Hartkapseln


10 mg


Capsule, hard


oral use




Germany







HEXAL AG




Postfach 1263




83602 Holzkirchen




Germany






Sibutramin-HEXAL 15 mg Hartkapseln


15 mg


Capsule, hard


oral use




Greece







Abbott Laboratories (Hellas) S.A.




512, Vouliagmenis Avenue




GR 17456, Alimos




Athens




Greece






Reductil


10 mg


Capsule, hard


oral use




Greece







Abbott Laboratories (Hellas) S.A.




512, Vouliagmenis Avenue




GR 17456, Alimos




Athens




Greece






Reductil


15 mg


Capsule, hard


oral use




Greece







Teva Pharmaceuticals Europe B.V.




European Headquarters




Computerweg 10




3542 DR Utrecht




The Netherlands






Sibutramine/Teva


10 mg


Capsule, hard


oral use




Greece







Teva Pharmaceuticals Europe B.V.




European Headquarters




Computerweg 10




3542 DR Utrecht




The Netherlands






Sibutramine/Teva


15 mg


Capsule, hard


oral use




Hungary







Zentiva k. s.




U Kabelovny 130




102 37 Praha 10




Czech Republic






LINDAXA


10 mg


Capsule, hard


oral use




Hungary







Zentiva k. s.




U Kabelovny 130




102 37 Praha 10




Czech Republic






LINDAXA


15 mg


Capsule, hard


oral use




Hungary







Teva Magyarország zrt.




Rákóczi út 70-72.




1074 Budapest




Hungary






MINIMECTIL


10 mg


Capsule, hard


oral use




Hungary







Teva Magyarország zrt.




Rákóczi út 70-72.




1074 Budapest




Hungary






MINIMECTIL


15 mg


Capsule, hard


oral use




Hungary







Abbott Laboratories Kft.




Teve u. 1/a-c




1139 Budapest




Hungary






REDUCTIL


10 mg


Capsule, hard


oral use




Hungary







Abbott Laboratories Kft.




Teve u. 1/a-c




1139 Budapest




Hungary






REDUCTIL


15 mg


Capsule, hard


oral use




Iceland







Abbott Scandinavia




Gårdsvägen 8




Box 5091




SE-169 29 Solna




Sweden






Reductil


10 mg


Capsule, hard


oral use




Iceland







Abbott Scandinavia




Gårdsvägen 8




Box 5091




SE-169 29 Solna




Sweden






Reductil


15 mg


Capsule, hard


oral use




Ireland







Teva Pharma B.V.




Computerweg 10




3542 Dr Utrecht




Netherlands






Sibutramine Teva 10 mg Capsules


10 mg


Capsule, hard


oral use




Ireland







Teva Pharma B.V.




Computerweg 10




3542 Dr Utrecht




Netherlands






Sibutramine Teva 15 mg Capsules


15 mg


Capsule, hard


oral use




Ireland







Abbot Laboratories Ireland Ltd




4051 Kingswood Drive




Citywest Business Campus




Dublin 24




Ireland






Reductil 10 mg capsules, hard


10 mg


Capsule, hard


oral use




Ireland







Abbot Laboratories Ireland Ltd




4051 Kingswood Drive




Citywest Business Campus




Dublin 24




Ireland






Reductil 15 mg capsules, hard


15 mg


Capsule, hard


oral use




Ireland







Rowex Ltd




Bantry




Co.Cork




Ireland






Sitrane 10 mg hard capsules


10 mg


Capsule, hard


oral use




Ireland







Rowex Ltd




Bantry




Co.Cork




Ireland






Sitrane 15 mg hard capsules


15 mg


Capsule, hard


oral use




Italy







ABBOTT srl




Via Pontina Km 52




04010 Campoverde di Aprilia




Italy






REDUXATE


10 mg


capsule


oral use




Italy







ABBOTT srl




Via Pontina Km 52




04010 Campoverde di Aprilia




Italy






REDUXATE


15 mg


capsule


oral use




Italy







ABBOTT srl




Via Pontina Km 52




04010 Campoverde di Aprilia




Italy






ECTIVA


10 mg


capsule


oral use




Italy







ABBOTT srl




Via Pontina Km 52




04010 Campoverde di Aprilia




Italy






ECTIVA


15 mg


capsule


oral use




Italy







ABBOTT srl




Via Pontina Km 52




04010 Campoverde di Aprilia




Italy






REDUCTIL


10 mg


capsule


oral use




Italy







ABBOTT srl




Via Pontina Km 52




04010 Campoverde di Aprilia




Italy






REDUCTIL


15 mg


capsule


oral use




Latvia







Abbott GmbH & Co. KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






Reductil 15 mg hard capsules


15 mg


Capsule, hard


oral use




Latvia







Abbott GmbH & Co. KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






Reductil 10 mg hard capsules


10 mg


Capsule, hard


oral use




Latvia







Sandoz d.d.




Verovškova 57




1000 Ljubljana




Slovenia






Sibutril 15 mg capsules, hard


15 mg


Capsule, hard


oral




Latvia







Sandoz d.d.




Verovškova 57




1000 Ljubljana




Slovenia






Sibutril 10 mg capsules, hard


10 mg


Capsule, hard


oral




Lithuania







Abbott GmbH & Co. KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






Reductil


10 mg


Capsule, hard


oral use




Lithuania







Abbott GmbH & Co. KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






Reductil


15 mg


Capsule, hard


oral use




Lithuania







Zentiva k. s.




U kabelovny 130




10237 Prague 10 Dolni Mecholupy Czech Republic






Lindaxa


10 mg


Capsule, hard


oral use




Lithuania







Zentiva k. s.




U kabelovny 130




10237 Prague 10 Dolni Mecholupy Czech Republic






Lindaxa


15 mg


Capsule, hard


oral use




Lithuania







Sandoz d.d.




Verovskova 57




1000 Ljubljana




Slovenia






Sibutril


10 mg


Capsule, hard


oral use




Lithuania







Sandoz d.d.




Verovskova 57




1000 Ljubljana




Slovenia






Sibutril


15 mg


Capsule, hard


oral use




Lithuania







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






Sibutramine Teva


10 mg


Capsule, hard


oral use




Lithuania







Teva Pharma B.V.




Computerweg 10




3542 DR Utrecht




The Netherlands






Sibutramine Teva


15 mg


Capsule, hard


oral use




Luxembourg







Abbott Laboratoires




2, rue du Bosquet




B- 1348 Ottignies L.L.N.




Belgium






Reductil


10 mg


capsule


oral use




Luxembourg







Abbott Laboratoires




2, rue du Bosquet




B- 1348 Ottignies L.L.N.




Belgium






Reductil


15 mg


capsules


oral use




Malta







Abbott Laboratories Limited Queenborough




Kent




ME11 5EL




United Kingdom






Reductil


10 mg


Capsule, hard


oral use




Malta







Abbott Laboratories Limited Queenborough




Kent




ME11 5EL




United Kingdom






Reductil


15 mg


Capsule, hard


oral use




Netherlands







Abbott B.V.




Siriusdreef 51




2132 WT, Hoofddorp




Netherlands






Reductil 10 mg, capsules, hard


10 mg


Capsule, hard


oral use




Netherlands







Abbott B.V.




Siriusdreef 51




2132 WT, Hoofddorp




Netherlands






Reductil 15 mg, capsules, hard


15 mg


Capsule, hard


oral use




Netherlands







Sandoz B.V.




Veluwezoom 22




1327 AH, Almere




Netherlands






Sibutramine HCL monohydraat Sandoz 10 mg, harde capsules


10 mg


Capsule, hard


oral use




Netherlands







Sandoz B.V.




Veluwezoom 22




1327 AH, Almere




Netherlands






Sibutramine HCL monohydraat Sandoz 15 mg, harde capsules


15 mg


Capsule, hard


oral use




Netherlands







Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144




8226 JX, Lelystad




Netherlands






Reductil 15 mg, capsules


15 mg


Capsule, hard


oral use




Netherlands







Medcor Pharmaceuticals B.V. Ketelmeerstraat 142-144




8226 JX, Lelystad




Netherlands






Reductil 10 mg, capsules


10 mg


Capsule, hard


oral use




Netherlands







Pharmachemie B.V.




Swensweg 5




2031 GA, Haarlem




Netherlands






Sibutramine HCL- monohydraat 10 mg PCH, capsules


10 mg


Capsule, hard


oral use




Netherlands







Pharmachemie B.V.




Swensweg 5




2031 GA, Haarlem




Netherlands






Sibutramine HCL- monohydraat 15 mg PCH, capsules


15 mg


Capsule, hard


oral use




Norway







Abbot Scandinavia




AB Box 509




169 29 Solna




Sweden






REDUCTIL


10 mg


Capsule, hard


oral use




Norway







Abbot Scandinavia




AB Box 509




169 29 Solna




Sweden






REDUCTIL


15 mg


Capsule, hard


oral use




Norway







Euromedica Norge AS




Jerikoveien 28 C




1067 Oslo




Norway






REDUCTIL


10 mg


Capsule, hard


oral use




Norway







Euromedica Norge AS




Jerikoveien 28 C




1067 Oslo




Norway






REDUCTIL


15 mg


Capsule, hard


oral use




Norway







Sandoz A/




Edvard Thomsens Vej 14




2300 København S




Danmark






SIBUTRAMIN SANDOZ


10 mg


Capsule, hard


oral use




Norway







Sandoz A/




Edvard Thomsens Vej 14




2300 København S




Danmark






SIBUTRAMIN SANDOZ


15 mg


Capsule, hard


oral use




Poland







Teva Pharmaceuticals Polska Sp. z o.o.




53 Emilii Plater St.




00-113 Warsaw




Poland






Afibron


10 mg


Capsule, hard


oral use




Poland







Teva Pharmaceuticals Polska Sp. z o.o.




53 Emilii Plater St.




00-113 Warsaw




Poland






Afibron


15 mg


Capsule, hard


oral use




Poland







Zentiva a.s.




U Kabelovny 130




Dolni Mecholupy




102 37 Praha 10




Czech Republic






Lindaxa 10


10 mg


Capsule, hard


oral use




Poland







Zentiva a.s.




U Kabelovny 130




Dolni Mecholupy




102 37 Praha 10




Czech Republic






Lindaxa 15


15 mg


Capsule, hard


oral use




Poland







Abbott Laboratories Poland Sp. z o. o.




ul. Postępu 18A




02-676 Warsaw




Poland






Meridia 10


10 mg


Capsule, hard


oral use




Poland







Abbott Laboratories Poland Sp. z o. o.




ul. Postępu 18A




02-676 Warsaw




Poland






Meridia 15


15 mg


Capsule, hard


oral use




Poland







Sandoz GmbH




Biochemiestrasse 10




A-6250 Kundl




Austria






Obesan


10 mg


Capsule, hard


oral use




Poland







Sandoz GmbH




Biochemiestrasse 10




A-6250 Kundl




Austria






Obesan


15 mg


Capsule, hard


oral use




Poland







1A Pharma GmbH




Keltenring 1 + 3




82041 Oberhaching






Sibutramine-1A Pharma


10 mg


Capsule, hard


oral use




Poland







1A Pharma GmbH




Keltenring 1 + 3




82041 Oberhaching




Germany






Sibutramine-1A Pharma


15 mg


Capsule, hard


oral use




Poland







Biofarm Sp. z o.o.




Wałbrzyska 13, 60-198




Poznan




Poland






Zelixa


10 mg


Film-coated tablet


oral use




Poland







Biofarm Sp. z o.o.




Wałbrzyska 13, 60-198




Poznan




Poland






Zelixa


15 mg


Film-coated tablet


oral use




Portugal







ABBOTT LABORATORIOS, LDA




Estrada Alfragide 67-AlfraparK-Edifício D,




2610-008 AMADORA




Portugal






Zelium


10 mg


Capsule, hard


oral use




Portugal







ABBOTT LABORATORIOS, LDA




Estrada Alfragide 67-AlfraparK-Edifício D,




2610-008 AMADORA




Portugal






Zelium


15 mg


Capsule, hard


oral use




Portugal







ABBOTT LABORATORIOS, LDA




Estrada Alfragide 67-AlfraparK-Edifício D,




2610-008 AMADORA




Portugal






Reductil


10 mg


Capsule, hard


oral use




Portugal







ABBOTT LABORATORIOS, LDA




Estrada Alfragide 67-AlfraparK-Edifício D,




2610-008 AMADORA




Portugal






Reductil


15 mg


Capsule, hard


oral use




Portugal







Teva Pharma –




Produtos Farmacêuticos, Lda.




Empreendimento Lagoas Park




Edifício 1 - 3




2740-264 Porto Salvo




Portugal






Sibutramina Teva


10 mg


Capsule, hard


oral use




Portugal







Teva Pharma –




Produtos Farmacêuticos, Lda.




Empreendimento Lagoas Park




Edifício 1 - 3




2740-264 Porto Salvo




Portugal






Sibutramina Teva


15 mg


Capsule, hard


oral use




Portugal







Solufarma - Produtos Farmacêuticos Unipessoal, Lda.




Rua do Tejo, 56 - 9o A Esq




2775-325 Parede




Portugal






Sibutramina Sibulaite


10 mg


Capsule, hard


oral use




Portugal







Solufarma - Produtos Farmacêuticos Unipessoal, Lda




Rua do Tejo, 56 - 9o A Esq




2775-325 Parede




Portugal






Sibutramina Sibulaite


15 mg


Capsule, hard


oral use




Portugal







Solufarma - Produtos Farmacêuticos Unipessoal, Lda




Rua do Tejo, 56 - 9o A Esq




2775-325 Parede




Portugal






Sibutramina Solufarma


10 mg


Capsule, hard


oral use




Portugal







Solufarma - Produtos Farmacêuticos Unipessoal, Lda




Rua do Tejo, 56 - 9o A Esq




2775-325 Parede




Portugal






Sibutramina Solufarma


15 mg


Capsule, hard


oral use




Portugal







Farmoz - Sociedade Técnico Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Farmoz


10 mg


Capsule, hard


oral use




Portugal







Farmoz - Sociedade Técnico Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Farmoz


15 mg


Capsule, hard


oral use




Portugal







Pentafarma - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, no 2 -Abrunheira




2710-089 Sintra




Portugal






Sibutramina Egostar


10 mg


Capsule, hard


oral use




Portugal







Pentafarma - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, no 2 Abrunheira




2710-089 Sintra




Portugal






Sibutramina Egostar


15 mg


Capsule, hard


oral use




Portugal







Pentafarma - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, no 2 Abrunheira




2710-089 Sintra




Portugal






Sibutramina Blixie


10 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Blixie


15 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Atrolex


10 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Atrolex


15 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Argam


10 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Argam


15 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal.






Sibutramina Orexinib


10 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Orexinib


15 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Snomas


10 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Snomas


15 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Arpedex


10 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Arpedex


15 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Marcoliz


10 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Marcoliz


15 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Ocram


10 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Ocram


15 mg


Capsule, hard


oral use




Portugal







Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda




Av. Sidónio Pais, n.o 24,




rés-do-chão esq




São Sebastião da Pedreira




1000 Lisboa




Portugal






Sibutramina Strami


10 mg


Capsule, hard


oral use




Portugal







Verum Pharma - Produtos Farmacêuticos - Unipessoal, Lda




Av. Sidónio Pais, n.o 24,




rés-do-chão esq,




São Sebastião da Pedreira




1000 Lisboa




Portugal






Sibutramina Strami


15 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Fililex


10 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina Fililex


15 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina West Pharma


10 mg


Capsule, hard


oral use




Portugal







Tecnimede - Sociedade Técnico-Medicinal, S.A.




Rua da Tapada Grande, 2




Abrunheira




2710-089 Sintra




Portugal






Sibutramina West Pharma


15 mg


Capsule, hard


oral use




Portugal







Generis Farmacêutica, S.A.




Office Park da Beloura,




Edifício 4,




Quinta da Beloura




2710-444 Sintra




Portugal






Sibutramina Generis


8,37 mg


Capsule, hard


oral use




Portugal







Generis Farmacêutica, S.A.




Office Park da Beloura,




Edifício 4,




Quinta da Beloura




2710-444 Sintra




Portugal






Sibutramina Generis


12,556 mg


Capsule, hard


oral use




Portugal







Sandoz Farmacêutica, Lda.




Alameda da Beloura,




Edifício 1, 2o - Escritório 15




2710-693 Sintra




Portugal






Sibutramina Sandoz


10 mg


Capsule, hard


oral use




Portugal







Sandoz Farmacêutica, Lda.




Alameda da Beloura, Edifício 1, 2o - Escritório 15




2710-693 Sintra




Portugal






Sibutramina Sandoz


15 mg


Capsule, hard


oral use




Romania







Abbott GmbH & Co.KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






REDUCTIL 10 mg, capsule


10 mg


Capsule, hard


oral use




Romania







Abbott GmbH & Co.KG




Max-Planck-Ring 2




65205 Wiesbaden




Germany






REDUCTIL 15 mg, capsule


15 mg


Capsule, hard


oral use




Romania







SANDOZ S.R.L. ROMÂNIA




Str. Livezeni nr. 7A,




Târgu Mureș,




Romania






MINIMACIN 10 mg, capsule


10 mg


Capsule, hard


oral use




Romania







SANDOZ S.R.L. ROMÂNIA




Str. Livezeni nr. 7A,




Târgu Mureș,




Romania






MINIMACIN 15 mg, capsule


15 mg


Capsule, hard


oral use




Romania







S.C. TERAPIA S.A.




Str. Fabricii, nr. 124,




Cluj-Napoca,




Romania






SILUTON 10 mg, capsule


10 mg


Capsule, hard


oral use




Romania







S.C. TERAPIA S.A.




Str. Fabricii, nr. 124,




Cluj-Napoca,




Romania






SILUTON 15 mg, capsule


15 mg


Capsule, hard


oral use




Romania







TEVA PHARMACEUTICALS S.R.L.




Str. Domnița Ruxandra nr 12, parter,




Sector 2, București




Romania






SIBUTRAMINĂ TEVA 10 mg, capsule


10 mg


Capsule, hard


oral use




Romania







TEVA PHARMACEUTICALS S.R.L.




Str. Domnița Ruxandra nr 12, parter,




Sector 2, București




Romania






SIBUTRAMINĂ TEVA 15 mg, capsule


15 mg


Capsule, hard


oral use




Romania







ZENTIVA a.s.,




U kabelovny 130,




102 37 Praga-10 Dolní Měcholupy, Czech Republic






LINDAXA 10 mg, capsule


10 mg


Capsule, hard


oral use




Romania







ZENTIVA a.s.,




U kabelovny 130,




102 37 Praga-10 Dolní Měcholupy




Czech Republic






LINDAXA 15 mg, capsule


15 mg


Capsule, hard


oral use




Slovakia







Zentiva, k.s.




Evropská 846/176a




160 00 Praha 6




Czech Republic






LINDAXA 10


10 mg


Capsule, hard


oral use




Slovakia







Zentiva, k.s.




Evropská 846/176a




160 00 Praha 6




Czech Republic






LINDAXA 15


15 mg


Capsule, hard


oral use




Slovakia







TEVA Pharmaceuticals Slovakia s.r.o.




Teslova 26, 821 02, Bratislava




Slovak Republic






Sibutramin - Teva 10 mg kapsuly


10 mg


Capsule, hard


oral use




Slovakia







TEVA Pharmaceuticals Slovakia s.r.o.




Teslova 26, 821 02 Bratislava




Slovak Republic






Sibutramin - Teva 15 mg kapsuly


15 mg


Capsule, hard


oral use




Slovakia







Abbott Laboratories Slovakia s.r.o.




Karadžicova 10




821 08 Bratislava




Slovak Republic






Reductil 10 mg


10 mg


capsule


oral use




Slovakia







Abbott Laboratories Slovakia s.r.o.




Karadžicova 10




821 08 Bratislava




Slovak Republic






Reductil 15 mg


15 mg


capsule


oral use




Slovenia







Abbott Laboratories d.o.o.




Dolenjska c. 242c




SI-1000 Ljubljana




Slovenia






Reductil 10 mg trde kapsule


10 mg


Capsule, hard


oral use




Slovenia







Abbott Laboratories d.o.o.




Dolenjska c. 242c




SI-1000 Ljubljana




Slovenia






Reductil 15 mg trde kapsule


15 mg


Capsule, hard


oral use




Slovenia







Lek farmacevtska družba d.d., Verovškova c. 57




SI-1000 Ljubljana




Slovenia






Sibutramin Lek 10 mg trde kapsule


10 mg


Capsule, hard


oral use




Slovenia







Lek farmacevtska družba d.d., Verovškova c. 57




SI-1000 Ljubljana




Slovenia






Sibutramin Lek 15 mg trde kapsule


15 mg


Capsule, hard


oral use




Spain







ABBOTT LABORATORIES, S.A.




Avda. de Burgos




28050 Madrid




Spain






REDUCTIL


10 mg


Capsule, hard


oral use




Spain







ABBOTT LABORATORIES, S.A.




Avda. de Burgos




28050 Madrid




Spain






REDUCTIL


15 mg


Capsule, hard


oral use




Spain







TEVA GENERICOS ESPAÑOLA, S.L.




Guzmán el Bueno 133




Edificio Britania 4oIzq.




28003 MADRID




Spain






SIBUTRAMINA TEVA


10 mg


Capsule, hard


oral use




Spain







TEVA GENERICOS ESPAÑOLA, S.L.




Guzmán el Bueno 133




Edificio Britania 4oIzq.




28003 MADRID




Spain






SIBUTRAMINA TEVA


15 mg


Capsule, hard


oral use




Spain







IDIFARMA, DESARROLLO FARMACEUTICO




Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra)




Spain






SIBUTRAMINA IDIFARMA


10 mg


Capsule, hard


oral use




Spain







IDIFARMA, DESARROLLO FARMACEUTICO.




Polígono Mocholí. Plaza CEIN 5, Nave B-14Noain (Navarra)




Spain






SIBUTRAMINA IDIFARMA


15 mg


Capsule, hard


oral use




Sweden







Abbott Scandinavia AB




Box 509 169 29 Solna




Sweden






Reductil


10 mg


Capsule, hard


oral use




Sweden







Abbott Scandinavia AB




Box 509 169 29 Solna




Sweden






Reductil


15 mg


Capsule, hard


oral use




Sweden







Sandoz A/S, C.F.




Tietgens Boulevard 40




DK-5220 Odense SØ




Danmark






Sibutramin Sandoz


10 mg


Capsule, hard


oral use




Sweden







Sandoz A/S, C.F.




Tietgens Boulevard 40




DK-5220 Odense SØ




Danmark






Sibutramin Sandoz


15 mg


Capsule, hard


oral use




Sweden







Teva Sweden AB




Box 1070




251 10 Helsingborg




Sweden






Sibutramine Teva


10 mg


Capsule, hard


Oral use




Sweden







Teva Sweden AB




Box 1070




251 10 Helsingborg




Sweden






Sibutramine Teva


15 mg


Capsule, hard


Oral use




United Kingdom







Abbott Laboratories Limited




Queenborough




Kent ME11 5EL




United Kingdom






Reductil 10 mg


10 mg


Capsule, hard


oral use




United Kingdom







Abbott Laboratories Limited




Queenborough




Kent ME11 5EL




United Kingdom






Reductil 15 mg


15 mg


Capsule, hard


oral use




United Kingdom







Teva UK Limited




Brampton Road




Hampden Park




Eastbourne, East Sussex BN22 9AG




United Kingdom






Sibutramine Hydrochloride 15 mg Capsules


10 mg


Capsule, hard


oral use




United Kingdom







Teva UK Limited




Brampton Road




Hampden Park




Eastbourne, East Sussex BN22 9AG




United Kingdom






Sibutramine Hydrochloride 10 mg Capsules


15 mg


Capsule, hard


oral use







ANNEX XVI

LIST OF THE NAME, PHARMACEUTICAL FORM, STRENGTH OF THE VETERINARY MEDICINAL PRODUCT, ANIMAL SPECIES, ROUTE(S) OF ADMINISTRATION, MARKETING AUTHORISATION HOLDER IN THE MEMBER STATES














Member State


Applicant or Marketing Authorisation Holder


Product invented name


Pharmaceutical form


Strength


Animal species


Frequency and route of administration


Recommended dose


Withdrawal period




United Kingdom


CEVA Animal Health Limited


Tildren 500 mg lyophilisate for solution for infusion


Lyophilisate for solution for infusion


500 mg


Horses


Once (the treatment may be repeated on the advice of the veterinary surgeon)
Intravenous use


1 mg/kg body weight (5 ml reconstituted solution per 100 kg)


Zero days
Not permitted for use in lactating animals producing milk for human consumption




Germany


CEVA Animal Health Limited


Tildren 500 mg lyophilisate for solution for infusion


Lyophilisate for solution for infusion


500 mg


Horses


Once (the treatment may be repeated on the advice of the veterinary surgeon)
Intravenous use


1 mg/kg body weight (5 ml reconstituted solution per 100 kg)


Zero days
Not permitted for use in lactating animals producing milk for human consumption







ANNEX XVII

LIST OF THE INVENTED NAMES, PHARMACEUTICAL FORMS, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTES OF ADMINISTRATION AND MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES (EEA)











Member State EU/EEA


Marketing Authorisation Holder


(Invented) Name


Strength


Pharmaceutical Form


Route of administration




Austria







Dermapharm GmbH




Türkenstraße 25/12




A-1090 Wien




Austria






Parfenac - Creme


50 mg/g


Cream


Cutaneous use




Austria







Dermapharm GmbH




Türkenstraße 25/12




A-1090 Wien




Austria






Parfenac - dermatologische Emulsion


50 mg/g


Cutaneous emulsion


Cutaneous use




Austria







Dermapharm GmbH




Türkenstraße 25/12




A-1090 Wien




Austria






Parfenac - Fettsalbe


50 mg/g


Ointment


Cutaneous use




Austria







Dermapharm GmbH




Türkenstraße 25/12




A-1090 Wien




Austria






Parfenac - Salbe


50 mg/g


Ointment


Cutaneous use




Bulgaria







Stada Arzneimittel AG,




Stadastrasse 2-18




61118 Bad Vilbel




Germany






Mastu S Forte


Bufexamac 250 mg, Bismuth subgallate 100 mg, Titanium dioxide 100 mg, Lidocaine hydrochloride 10 mg


Suppositories


Rectal use




Bulgaria







Stada Arzneimittel AG




Stadastrasse 2-18




61118 Bad Vilbel




Germany






Mastu S


Bufexamac 50 mg/g, Bismuth subgallate 50 mg/g, Titanium dioxide 50 mg/g, Lidocaine hydrochloride 5 mg/g


Rectal ointment


Rectal use




Czech Republic







STADA Arzneimittel AG




Stadastrasse 2-18




61118 Bad Vilbel




Germany






MASTU S FORTE


Bufexamac 250 mg, Bismuth subgallate 100 mg, Titanium dioxide 100 mg, Lidocaine hydrochloride 10 mg


suppository


Rectal use




Czech Republic







STADA Arzneimittel AG




Stadastrasse 2-18




61118 Bad Vilbel




Germany






MASTU S


Bufexamac 50 mg/g, Bismuth subgallate 50 mg/g, Titanium dioxide 50 mg/g, Lidocaine hydrochloride 5 mg/g


rectal ointment


Rectal use




France







Pierre Fabre Medicament




45 place Abel Gance




92654 Boulogne cedex




France






BUFAL 5 POUR CENT, crème en tube


5 g/100 g


cream


Cutaneous use




France







Coopération Pharmaceutique Française




Place Lucien Auvert




77020 Melun cedex




France






BUFEXAMAC COOPER 5 pour cent, crème


5 g/100 g


cream


Cutaneous use




France







Wyeth Pharmaceuticals France




Cœur Défense Tour A




la Défanse 4




92931 Paris La Défense Cedex




France






BUFEXAMAC NOVALIS 5 pour cent, crème


5 g/100 g


cream


Cutaneous use




France







Wyeth Pharmaceuticals France




Cœur Défense Tour A




la Défanse 4




92931 Paris La Défense Cedex




France






CALMADERM, crème pour application cutannée


5 g/100 g


cream


Cutaneous use




France







Wyeth Pharmaceuticals France




Cœur Défense Tour A




la Défanse 4




92931 Paris La Défense Cedex




France






PARFENAC 5 POUR CENT, crème


5 g/100 g


cream


Cutaneous use




France







Wyeth Pharmaceuticals France




Cœur Défense Tour A




la Défanse 4




92931 Paris La Défense Cedex




France






PARFENOIDE, crème pour application locale


5 g/100 g


cream


Cutaneous use




Hungary







Stada Arzneimittel AG




Stadastrasse 2-18




61118 Bad Vilbel




Germany






Mastu S


50 mg Bufexamac (+5 mg Lidocaine)/ 1 g


ointment


Cutaneous use




Hungary







Stada Arzneimittel AG




Stadastrasse 2-18




61118 Bad Vilbel




Germany






Mastu S Forte


250 mg Bufexamac, +10 mg Lijdocaine


suppository


Rectal use




Italy







Farmigea spa




Via Giovan Battista Oliva 6/8




56121 PISA




Italy






FANSAMAC


5 g/100 g


cream


Cutaneous use




Latvia







Stada Arzneimittel AG,




Stadastraße 2-18




61118 Bad Vilbel




Germany






Mastu S ointment


Bismuthi subgallas 50 mg, Bufexamacum 50 mg, Titanii dioxidum 50 mg Lidocaini hydrochloridum 5 mg/g


Ointment


Rectal use and Cutaneous use




Latvia







Stada Arzneimittel AG




Stadastraße 2-18




61118 Bad Vilbel,




Germany






Mastu S forte suppositories


Titanii dioxidum 250 mg, Lidocaini hydrochloridum 100 mg, Bismuthi subgallas 100 mg, Bufexamacum 10 mg


Suppositories


Rectal use




Lithuania







Stada Arzneimittel AG




Stadastrasse 2-18




61118 Bad Vilbel




Germany






Mastu S


Bufexamac 50 mg/g, Bismuth subgallate 50 mg/g, Titanium dioxide 50 mg/g, Lidocaine hydrochloride monohydrate 5 mg/g


Ointment


Cutaneous use




Lithuania







Stada Arzneimittel AG




Stadastrasse 2-18




61118 Bad Vilbel




Germany






Mastu S forte


Bufexamac 250 mg, Bismuth subgallate 100 mg, Titanium dioxide 100 mg, Lidocaine hydrochloride monohydrate 10 mg


Suppository


Rectal use




Luxembourg







PF MEDICAMENT




45, Place Abel Gance




92654 Boulogne Cedex




France






BUFAL


5 g/100 g


cream


Cutaneous use




Portugal







Home Products de Portugal, Lda. Rua Dr. António Loureiro Borges




2 - Arquiparque - Miraflores




1495-131 Algés




Portugal






Parfenac


50 mg/g


Ointment


Cutaneous use




Romania







STADA ARZNEIMITTEL AG




Stadastrasse 2-18




61118 Bad Vilbel




Germany






PROCTOSAN FORTE, suppository


250 mg


suppository


Rectal use




Romania







STADA ARZNEIMITTEL AG




Stadastrasse 2-18




61118 Bad Vilbel




Germany






PROCTOSAN, rectal cream


50 mg


rectal cream


Rectal use




Slovakia







STADA Arzneimittel AG




Stadastrasse 2 - 18




61118 Bad Vilbel




Germany






MASTU S


50 mg/1 g


Rectal ointment


Rectal use




Slovakia







STADA Arzneimittel AG




Stadastrasse 2 - 18




61118 Bad Vilbel




Germany






MASTU S forte


250 mg


Suppository


Rectal use