Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 2009 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Date: 2009-07-31
Institutions: European Commission
Subjects: EU Member State, market approval, marketing, marketing standard, medicinal product, pharmaceutical legislation, withdrawal from the market








C_2009178EN.01002401.xml










31.7.2009   


EN


Official Journal of the European Union


C 178/24





Summary of Community decisions on marketing authorisations in respect of medicinal products from 1 June 2009 to 30 June 2009

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

2009/C 178/13
—   Issuing, maintenance or modification of a national marketing authorisation










Date of the decision


Name(s) of the medicinal product


Holder(s) of the marketing authorisation


Member State concerned


Date of notification




2.6.2009


Betavert N


See Annex I


See Annex I


3.6.2009




10.6.2009


Renvela







Genzyme Europe B.V.




Gooimeer 10




1411 DD Naarden




NEDERLAND






This Decision is addressed to the Member States


11.6.2009




22.6.2009


Aclasta







Novartis Europharm Limited




Wimblehurst Road




Horsham




West Sussex




RH12 5AB




UNITED KINGDOM






This Decision is addressed to the Member States


24.6.2009






(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 FORM, STRENGTHS OF THE MEDICINAL PRODUCTS, ROUTE OF ADMINISTRATION, APPLICANTS/MARKETING AUTHORISATION HOLDERS IN THE MEMBER STATES












Member State EU/EEA


Marketing Authorisation Holder


Applicant


(Invented) Name


Strength


Pharmaceutical Form


Route of Administration




Austria


 







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






Vertimen 8 mg Tabletten


8 mg


tablet


oral use




Austria


 







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






Vertimen 16 mg Tabletten


16 mg


tablet


oral use




Bulgaria


 







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






Vertisan 8 mg Таблетка


8 mg


tablet


oral use




Bulgaria


 







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






Vertisan 16 mg Таблетка


16 mg


tablet


oral use




Czech Republic


 







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






Vertisan® 8 mg Tableta


8 mg


tablet


oral use




Czech Republic


 







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






Vertisan® 16 mg Tableta


16 mg


tablet


oral use




Germany







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






 


Betavert® N 8 mg Tabletten


8 mg


tablet


oral use




Germany







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






 


Betavert® N 16 mg Tabletten


16 mg


tablet


oral use




Hungary


 







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






Vertisan® N 8 mg Tabletta


8 mg


tablet


oral use




Hungary


 







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






Vertisan® N 16 mg Tabletta


16 mg


tablet


oral use




Poland


 







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






Vertisan 8


8 mg


tablet


oral use




Poland


 







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






Vertisan 16


16 mg


tablet


oral use




Romania


 







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






Vertisan® 8 mg Comprimate


8 mg


tablet


oral use




Romania


 







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






Vertisan® 16 mg Comprimate


16 mg


tablet


oral use




Slovak Republic


 







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






Vertisan® 8 mg Tablety


8 mg


tablet


oral use




Slovak Republic


 







HENNIG ARZNEIMITTEL




GmbH & Co. KG




Liebigstraße 1—2




65439 Flörsheim/Main




DEUTSCHLAND






Vertisan® 16 mg Tablety


16 mg


tablet


oral use