EN Official Journal of the European Union C 350/1

Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 30 September 2013

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

2013/C 350/01

— 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 25.9.2013 Sandimmun See Annex I See Annex I 26.9.2013 25.9.2013 Sandimmun Neoral See Annex II See Annex II 26.9.2013

(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 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 Content (concentration) Austria Novartis Pharma GmbH Stella-Klein-Löw-Weg 17 AT-1020 Wien Austria Sandimmun 50 mg – Konzentrat zur Infusionsbereitung 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Belgium N.V. Novartis Pharma S.A. Medialaan 40, bus 1 B-1800 Vilvoorde Belgium SANDIMMUN 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Czech Republic Novartis s.r.o. Na Pankráci 1724/129 140 00 Prague 4 - Nusle Czech Republic Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Denmark Novartis Healthcare A/S Lyngbyvej 172 DK-2100 Copenhagen Denmark Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Finland Novartis Finland OY Metsänneidonkuja 10 FI-02130 Espoo Finland Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml France Novartis Pharma S.A.S. 2-4, rue Lionel Terray 92500 RUEIL-MALMAISON, France SANDIMMUN 25 mg Capsule, soft Oral use France Novartis Pharma S.A.S. 2-4, rue Lionel Terray 92500 RUEIL-MALMAISON, France SANDIMMUN 50 mg Capsule, soft Oral use France Novartis Pharma S.A.S. 2- 4, rue Lionel Terray 92500 RUEIL-MALMAISON, France SANDIMMUN 100 mg Capsule, soft Oral use France Novartis Pharma S.A.S. 2- 4, rue Lionel Terray 92500 RUEIL-MALMAISON, France SANDIMMUN 100 mg/ml Oral solution Oral use 100 mg/ml France Novartis Pharma S.A.S. 2- 4, rue Lionel Terray 92500 RUEIL-MALMAISON, France SANDIMMUN 50 mg/ml Solution for infusion Intravenous use 50 mg/ml Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 25 mg Weichkapseln 25 mg Capsule, soft Oral use Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 100 mg Weichkapseln 100 mg Capsule, soft Oral use Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 100 mg/ml Lösung zum Einnehmen 100 mg/ml Oral solution Oral use 100 mg/ml Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Immunosporin 25 mg Weichkapseln 25 mg Capsule, soft Oral use Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Immunosporin 50 mg Weichkapseln 50 mg Capsule, soft Oral use Germany Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Immunosporin 100 mg Weichkapseln 100 mg Capsule, soft Oral use Greece Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens Greece SANDIMMUN 250 mg/5 ml amp Concentrate for solution for infusion Intravenous use 50 mg/ml Greece Novartis (Hellas) S.A.C.I. National Road No. 1 (12th Km) Metamorphosis GR-144 51 Athens Greece SANDIMMUN 50 mg/ml amp Concentrate for solution for infusion Intravenous use 50 mg/ml Hungary Novartis Hungária Kft. Pharma részlege Bartók Béla út 43-47 H-1114 Budapest Hungary Sandimmun 50 mg/ml koncentrátum oldatos infúzióhoz 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Iceland Novartis Healthcare A/S Edward Thomsens Vej 14 2003 Köbenhavn S Denmark Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun 25 mg Capsule, soft Oral use Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun 50 mg Capsule, soft Oral use Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun 100 mg Capsule, soft Oral use Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun 100 mg/ml Oral Solution Oral use 100 mg/ml Ireland Novartis Pharmaceuticals UNITED KINGDOM Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom Sandimmun 50 mg/1 ml Concentrate for solution for infusion Intravenous use 50 mg/ml Italy Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom SANDIMMUN 25 mg Capsule, soft Oral use Italy Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom SANDIMMUN 50 mg Capsule, soft Oral use Italy Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom SANDIMMUN 100 mg Capsule, soft Oral use Italy Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom SANDIMMUN 100 mg/ml Oral solution Oral use 100 mg/ml Italy Novartis Europharm Limited Wimblehurst Road Horsham West Sussex, RH12 5AB United Kingdom SANDIMMUN 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Luxembourg Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 25 mg Weichkapseln 25 mg Capsule, soft Oral use Luxembourg Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 100 mg Weichkapseln 100 mg Capsule, soft Oral use Luxembourg Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 100 mg/ml Lösung zum Einnehmen 100 mg/ml Oral solution Oral use 100 mg/ml Luxembourg Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 50 mg/ml Konzentrat zur Herstellung einer Infusionslösung 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Netherlands Novartis Pharma B.V. Raapopseweg 1 6824 DP Arnhem The Netherlands Sandimmune, concentraat voor oplossing voor intraveneuze infusie 50 mg/ml 50 mg/ml Concentrate for solution for intravenous infusion Intravenous use 50 mg/ml Norway Novartis Norge AS Nydalen Alle 37A P.O Box 4284 Nydalen, N-0401 Oslo Norway Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Poland Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous 50 mg/ml Portugal Novartis Farma - Produtos Farmacêuticos S.A. Rua do Centro Empresarial, Edificio 8 Quinta da Beloura P-2710-444 Sintra Portugal Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Slovak Republic Novartis s.r.o. Na Pankráci 1724/129 Prague 140 00 Czech Republic Sandimmun 50 mg/ml 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Slovenia Novartis Pharma GmbH Roonstrasse 25 D-90429 Nürnberg Germany Sandimmun 50 mg/ml koncentrat za raztopino za infundiranje 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Spain Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes, 764 E-08013 Barcelona Spain Sandimmun 50 mg/ml concentrado para solución para perfusión 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml Spain Novartis Farmacéutica S.A. Gran Via de les Corts Catalanes, 764 E-08013 Barcelona Spain Sandimmun 250 mg/5 ml concentrado para solución para perfusión 250 mg/5 ml Concentrate for solution for infusion Intravenous use 50 mg/ml Sweden Novartis Sverige AB Kemistvägen 1B / Box 1150 SE-183 11 Täby Sweden Sandimmun 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom SANDIMMUN Soft Gelatin Capsules 25 mg 25 mg Capsule, soft Oral use United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom SANDIMMUN Soft Gelatin Capsules 50 mg 50 mg Capsule, soft Oral use United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom SANDIMMUN Soft Gelatin Capsules 100 mg 100 mg Capsule, soft Oral use United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom SANDIMMUN Oral Solution 100 mg/ml Oral solution Oral use 100 mg/ml United Kingdom Novartis Pharmaceuticals UK Ltd Frimley Business Park Frimley, Camberley Surrey GU16 7SR United Kingdom SANDIMMUN Concentrate for Solution for Infusion 50 mg/ml 50 mg/ml Concentrate for solution for infusion Intravenous use 50 mg/ml