Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2012 to 31 August 2012 (Decisions taken pursuant to Article 34 of Directive 2001/83/EC or Article 38 of Directive 2001/82/EC )
Date: 2012-11-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2012371EN.01000201.xml










30.11.2012   


EN


Official Journal of the European Union


C 371/2





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2012 to 31 August 2012

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

2012/C 371/02
—   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




23.8.2012


Zinnat and associated names


See Annex


See Annex


27.8.2012






(1)  OJ L 311, 28.11.2001, p. 67.

(2)  OJ L 311, 28.11.2001, p. 1.


ANNEX

LIST OF THE NAMES, PHARMACEUTICAL FORMS, 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


Content
(concentration)




Austria







GlaxoSmithKline Pharma GmbH




Albert-Schweitzer-Gasse 6




1140 Wien




Austria






Flolan 0,5 mg - Trockensubstanz zur Infusionsbereitung mit Lösungsmittel


0,5 mg


Powder and solvent for solution for infusion


Intravenous use


0,5 mg/50 ml




Austria







GlaxoSmithKline Pharma GmbH




Albert-Schweitzer-Gasse 6




1140 Wien




Austria






Flolan 1,5 mg - Trockensubstanz zur Infusionsbereitung mit Lösungsmittel


1,5 mg


Powder and solvent for solution for infusion


Intravenous use


1,5 mg/100 ml




Belgium







GlaxoSmithKline s.a./n.v.




Rue du Tilleul 13




1332 Genval




Belgium






Flolan 0,5 mg powder and solvent for solution for infusion


0,5 mg


Powder and solvent for solution for infusion


Intravenous use


0,5 mg/50 ml




Belgium







GlaxoSmithKline s.a./n.v.




Rue du Tilleul 13




1332 Genval




Belgium






Flolan 1,5 mg powder and solvent for solution for infusion


1,5 mg


Powder and solvent for solution for infusion


Intravenous use


1,5 mg/100 ml




Belgium







GlaxoSmithKline s.a./n.v.




Rue du Tilleul 13




1332 Genval




Belgium






Flolan 1,5 mg powder for solution for infusion


1,5 mg


Powder for solution for infusion


Intravenous use


1,5 mg/50 ml




Czech Republic







The Wellcome Foundation Ltd.,




Berkeley Avenue 21,




Greenford, Middlesex,




UB6 0NN




United Kingdom






Flolan 0,5 mg, powder and solvent for solution for infusion


0,5 mg


Powder and solvent for solution for infusion


Intravenous use


0,5 mg/50 ml




Czech Republic







The Wellcome Foundation Ltd.,




Berkeley Avenue 21,




Greenford, Middlesex,




UB6 0NN




United Kingdom






Flolan 1,5 mg, powder and solvent for solution for infusion


1,5 mg


Powder and solvent for solution for infusion


Intravenous use


1,5 mg/50 ml




Denmark







GlaxoSmithKline




Pharma A/S




Nykaer 68,




2605 Broendby




Denmark






Epoprostenol 500 micrograms


0,5 mg


Powder and solvent for solution for infusion


Intravenous use


0,5 mg/50 ml




Denmark







GlaxoSmithKline




Pharma A/S




Nykaer 68,




2605 Broendby




Denmark






Eepoprostenol 1,5 mg


1,5 mg


Powder and solvent for solution for infusion


Intravenous use


1,5 mg/50 ml




Estonia







Glaxo Wellcome UK Limited trading as Glaxo Wellcome Operations




Glaxo Wellcome House




Berkeley Avenue, Greenford




Middlesex UB6 0NN




United Kingdom






Flolan


0,5 mg


Powder and solvent for solution for infusion


Intravenous use


0,5 mg/50 ml




France







Laboratoire GLAXOSMITHKLINE




100, route de Versailles




78163 Marly-le-Roi Cedex




France






Flolan 0,5 mg, powder and solvent for solution for injection


0,5 mg


Powder and solvent for solution for injection


Intravenous use


0,5 mg/50 ml




France







Laboratoire GLAXOSMITHKLINE




100, route de Versailles




78163 Marly-le-Roi Cedex




France






Flolan 1,5 mg, powder and solvent for solution for injection


1,5 mg


Powder and solvent for solution for injection


Intravenous use


1,5 mg/50 ml




Ireland







GlaxoSmithKline (Ireland) Limited




Stonemasons Way




Rathfarnham, Dublin 16




Ireland






Flolan 500 micrograms Powder and Solvent for Solution for Infusion


0,5 mg


Powder and solvent for solution for infusion


Intravenous use


0,5 mg/50 ml




Ireland







GlaxoSmithKline (Ireland) Limited




Stonemasons Way




Rathfarnham, Dublin 16




Ireland






Flolan 1,5 mg Infusion, powder and solvent for solution for infusion


1,5 mg


Powder and solvent for solution for infusion


Intravenous use


1,5 mg/50 ml




Italy







The Wellcome Foundation Ltd.




Glaxo Wellcome house




Berkeley Avenue




Greenford




Middlesex UB6 ONN




United Kingdom






Flolan


0,5 mg


Powder and solvent for solution for infusion


Intravenous use


0,5 mg/50 ml




Italy







The Wellcome Foundation Ltd.




Glaxo Wellcome house




Berkeley Avenue




Greenford




Middlesex UB6 ONN




United Kingdom






Flolan


0,5 mg


Powder for solution for infusion


Intravenous use


0,5 mg/100 ml




Italy







The Wellcome Foundation Ltd.




Glaxo Wellcome house




Berkeley Avenue




Greenford




Middlesex UB6 ONN




United Kingdom






Flolan


1,5 mg


Powder and solvent for solution for infusion


Intravenous use


1,5 mg/50 ml




Luxembourg







GlaxoSmithKline Pharmaceuticals SA




2-4-6, Avenue Pascal




B-1330 Wavre




Belgium






Flolan 0,5 mg powder and solvent for solution for infusion


0,5 mg


Powder and solvent for solution for infusion


Intravenous use


0,5 mg/50 ml




Luxembourg







GlaxoSmithKline Pharmaceuticals SA




2-4-6, Avenue Pascal




B-1330 Wavre




Belgium






Flolan 1,5 mg powder and solvent for solution for infusion


1,5 mg


Powder and solvent for solution for infusion


Intravenous use


1,5 mg/100 ml




Malta







Glaxo Wellcome UK Limited




Glaxo Wellcome House




Berkeley Avenue




Greenford




Middlesex UB6 ONN




United Kingdom






Flolan 0,5 mg Injection Powder and solvent for solution for Infusion 0,5 mg


0,5 mg


Powder and solvent for solution for infusion


Intravenous use


0,5 mg/50 ml




The Netherlands







GlaxoSmithKline B.V.




Huis ter Heideweg 62




3705 LZ Zeist




The Netherlands






Flolan 500 microgram, powder for solution for infusion


0,5 mg


Powder for solution for infusion


Intravenous use


0,5 mg/50 ml




The Netherlands







GlaxoSmithKline B.V.




Huis ter Heideweg 62




3705 LZ Zeist




The Netherlands






Flolan 500 microgram, powder and solvent for solution for infusion


0,5 mg


Powder and solvent for solution for infusion


Intravenous use


0,5 mg/100 ml




The Netherlands







GlaxoSmithKline B.V.




Huis ter Heideweg 62




3705 LZ Zeist




The Netherlands






Flolan 1500 microgram, powder for solution for infusion


1,5 mg


Powder for solution for infusion


Intravenous use


1,5 mg/50 ml




The Netherlands







GlaxoSmithKline B.V.




Huis ter Heideweg 62




3705 LZ Zeist




The Netherlands






Flolan 1500 microgram, powder and solvent for solution for infusion


1,5 mg


Powder and solvent for solution for infusion


Intravenous use


1,5 mg/100 ml




Norway







GlaxoSmithKline AS




Forskningsveien 2 A




Postboks 180 Vinderen




0319 Oslo




Norway






Flolan


0,5 mg


Powder and solvent for solution for infusion


Intravenous use


0,5 mg/100 ml




Norway







GlaxoSmithKline AS




Forskningsveien 2 A




Postboks 180 Vinderen




0319 OSLO




Norway






Flolan


1,5 mg


Powder and solvent for solution for infusion


Intravenous use


1,5 mg/100 ml




Spain







GlaxoSmithKline, S.A.




P.T.M. - C/Severo Ochoa, 2




28760 - Tres Cantos




Madrid




Spain






Flolan


0,5 mg


Powder and solvent for solution for infusion


Intravenous use


0,5 mg/50 ml




United Kingdom







Glaxo Wellcome UK Ltd




Stockley Park West




Uxbridge




Middlesex, UB11 1BT




United Kingdom






Flolan 0,5 mg Injection


0,5 mg


Freeze-Dried Powder


Intravenous use


0,5 mg/50 ml




United Kingdom







Glaxo Wellcome UK Ltd




Stockley Park West




Uxbridge




Middlesex, UB11 1BT




United Kingdom






Flolan 1,5 mg Injection


1,5 mg


Sterile freeze-dried powder for solution for infusion


Intravenous use


1,5 mg/50 ml