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) 2012/C 371/02
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Not the law itself: Notice
Address https://gelex.eu/eli/EU/notice/oj/C/2012/371/02@2012-11-30/en
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
ANNEX
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