(Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION

Transcription

1 EN Official Journal of the European Union C 361/1 IV (Notices) NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES EUROPEAN COMMISSION Summary of European Union s on marketing authorisations in respect of medicinal s from 1 September 2015 to 30 September 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council ( 1 )) (2015/C 361/01) ( 1 ) OJ L 136, , p. 1.

2 C 361/2 EN Official Journal of the European Union Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted INN (International Non-Proprietary Name) Holder of the marketing authorization Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) Ivabradine Anpharm ivabradine ANPHARM Przedsiębiorstwo Farmaceutyczne S.A. ul. Annopol 6B, Warszawa, Polska EU/1/15/1041 Film-coated tablet C01EB Raxone idebenone Santhera Pharmaceuticals (Deutschland) GmbH Marie-Curie Strasse 8, Lörrach, Deutschland EU/1/15/1020 Film-coated tablet N Pemetrexed Lilly pemetrexed Eli Lilly Nederland B.V. Grootslag 1-5, NL RA Houten, Nederland EU/1/15/1034 Intravenous use L01BA Intuniv guanfacine Shire Pharmaceuticals Ireland Limited 5 River Walk, Citywest Business Campus, Dublin 24, Ireland EU/1/15/1040 Prolonged-release tablet C02AC

3 EN Official Journal of the European Union C 361/3 INN (International Non-Proprietary Name) Holder of the marketing authorization Pemetrexed Sandoz pemetrexed Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich Zalviso Sufentanil Grünenthal GmbH Zieglerstrasse 6, D , Aachen, Deutschland Zerbaxa ceftolozane/tazobactam Fexeric ferric citrate coordination complex Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, Keryx Biopharma UK Ltd Riverbank House, 2 Swan Lane, London, EC4R 3TT, United Kingdom Praluent alirocumab Sanofi-Aventis groupe 54 rue La Boétie, F Paris, France Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) EU/1/15/1037 Powder for concentrate for solution for infusion L01BA EU/1/15/1042 Sublingual tablet N01AH EU/1/15/1032 Powder for concentrate for solution for infusion J01DI EU/1/15/1039 Film-coated tablet V03AE EU/1/15/1031 Solution for injection C

4 C 361/4 EN Official Journal of the European Union Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted ATryn GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom Daklinza Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, Ebixa H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark Enbrel Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, Esbriet Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, Extavia Novartis Europharm Limited Grastofil Apotex Europe B.V. Darwinweg 20, NL CR Leiden, Nederland Hirobriz Breezhaler Novartis Europharm Limited Plegridy Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, Xofigo Bayer Pharma AG D Berlin, Deutschland Xyrem UCB Pharma Ltd 208 Bath Road, Slough, Berkshire SL1 3WE, ADCETRIS Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark Betmiga Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland Elaprase Shire Human Genetic Therapies AB Svärdvägen 11D, SE Danderyd, Sverige Quinsair Aptalis Pharma SAS Route de Bû, F Houdan, France EU/1/06/ EU/1/14/ EU/1/02/ EU/1/99/ EU/1/11/ EU/1/08/ EU/1/13/ EU/1/09/ EU/1/14/ EU/1/13/ EU/1/05/ EU/1/12/ EU/1/12/ EU/1/06/ EU/1/14/

5 EN Official Journal of the European Union C 361/ Evoltra Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland EU/1/06/ Iclusig ARIAD Pharma Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, EU/1/13/ Imvanex Bavarian Nordic A/S Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark EU/1/13/ INOmax Linde Healthcare AB SE Lidingö, Sverige EU/1/01/ Metalyse Boehringer Ingelheim International GmbH Binger Straße 173, D Ingelheim am Rhein, Deutschland EU/1/00/ Perjeta Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, EU/1/13/ Ruconest Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland EU/1/10/ Sebivo Novartis Europharm Limited EU/1/07/ Spedra Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg EU/1/13/ TachoSil Takeda Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich EU/1/04/ Visudyne Novartis Europharm Limited EU/1/00/ Ilaris Novartis Europharm Limited EU/1/09/ Inflectra Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, EU/1/13/ Toviaz Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, EU/1/07/

6 C 361/6 EN Official Journal of the European Union Trajenta Boehringer Ingelheim International GmbH Binger Straße 173, D Ingelheim am Rhein, Deutschland Viagra Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, Arixtra Aspen Pharma Trading Limited 3016 Lake Drive Citywest Business Campus Dublin 24 Ireland Iasibon Pharmathen S.A. 6 Dervenakion, Pallini Attiki, Ελλάδα Sifrol Boehringer Ingelheim International GmbH Binger Straße 173, D Ingelheim am Rhein, Deutschland Vibativ Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, EU/1/11/ EU/1/98/ EU/1/02/ EU/1/10/ EU/1/97/ EU/1/11/ Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council) Biograstim AbZ-Pharma GmbH Graf-Arco-Straße 3, D Ulm, Deutschland EU/1/08/

7 EN Official Journal of the European Union C 361/7 Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted INN (International Non-Proprietary Name) Holder of the marketing authorization Pharmaceutical form ATC code (Anatomical Therapeutic Chemical Code) FORTEKOR PLUS pimobendan/benazepril Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG 24 9NL, United Kingdom Novaquin meloxicam Le Vet Beheer B.V. Wilgenweg 7, NL TV Oudewater, Nederland Vectormune ND Cell-associated live recombinant turkey herpes virus (rhvt/ ND) expressing the fusion protein of Newcastle diseases virus D-26 lentogenic strain CEVA-Phylaxia Co. Ltd Budapest, Szállás u. 5, 1107 MAGYAR- ORSZÁG EU/2/15/185 Tablet QC09BX EU/2/15/186 Oral suspension QM01AC EU/2/15/188 Suspension and solvent for suspension for injection QI01AD

8 C 361/8 EN Official Journal of the European Union Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted BTVPUR AlSap 1 Merial 29 avenue Tony Garnier, F Lyon, France BTVPUR AlSap 1-8 Merial 29 avenue Tony Garnier, F Lyon, France Meloxoral Le Vet B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland Onsior Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG 24 9NL, EU/2/10/ EU/2/10/ EU/2/10/ EU/2/08/ Anyone wishing to consult the public assessment report on the medicinal s in question and the s relating thereto is invited to contact: The European Medicines Agency 7, Westferry Circus, Canary Wharf UK LONDON E14 4H