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Document C:2015:361:FULL
Official Journal of the European Union, C 361, 30 October 2015
Official Journal of the European Union, C 361, 30 October 2015
Official Journal of the European Union, C 361, 30 October 2015
Display all documents published in this Official Journal
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ISSN 1977-091X |
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Official Journal of the European Union |
C 361 |
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English edition |
Information and Notices |
Volume 58 |
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Notice No |
Contents |
page |
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IV Notices |
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NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES |
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European Commission |
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2015/C 361/01 |
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EN |
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IV Notices
NOTICES FROM EUROPEAN UNION INSTITUTIONS, BODIES, OFFICES AND AGENCIES
European Commission
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30.10.2015 |
EN |
Official Journal of the European Union |
C 361/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products 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)
— Issuing of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
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8.9.2015 |
Ivabradine Anpharm |
ivabradine |
ANPHARM Przedsiębiorstwo Farmaceutyczne S.A. ul. Annopol 6B, 03-236 Warszawa, Polska |
EU/1/15/1041 |
Film-coated tablet |
C01EB17 |
10.9.2015 |
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8.9.2015 |
Raxone |
idebenone |
Santhera Pharmaceuticals (Deutschland) GmbH Marie-Curie Strasse 8, 79539 Lörrach, Deutschland |
EU/1/15/1020 |
Film-coated tablet |
N07 |
10.9.2015 |
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14.9.2015 |
Pemetrexed Lilly |
pemetrexed |
Eli Lilly Nederland B.V. Grootslag 1-5, NL-3991 RA Houten, Nederland |
EU/1/15/1034 |
Intravenous use |
L01BA04 |
16.9.2015 |
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17.9.2015 |
Intuniv |
guanfacine |
Shire Pharmaceuticals Ireland Limited 5 River Walk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/15/1040 |
Prolonged-release tablet |
C02AC02 |
21.9.2015 |
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18.9.2015 |
Pemetrexed Sandoz |
pemetrexed |
Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich |
EU/1/15/1037 |
Powder for concentrate for solution for infusion |
L01BA04 |
23.9.2015 |
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18.9.2015 |
Zalviso |
Sufentanil |
Grünenthal GmbH Zieglerstrasse 6, D-52078, Aachen, Deutschland |
EU/1/15/1042 |
Sublingual tablet |
N01AH03 |
22.9.2015 |
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18.9.2015 |
Zerbaxa |
ceftolozane/tazobactam |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/15/1032 |
Powder for concentrate for solution for infusion |
J01DI54 |
22.9.2015 |
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23.9.2015 |
Fexeric |
ferric citrate coordination complex |
Keryx Biopharma UK Ltd Riverbank House, 2 Swan Lane, London, EC4R 3TT, United Kingdom |
EU/1/15/1039 |
Film-coated tablet |
V03AE |
28.9.2015 |
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23.9.2015 |
Praluent |
alirocumab |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/15/1031 |
Solution for injection |
C10 |
25.9.2015 |
— Modification of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
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8.9.2015 |
ATryn |
GTC Biotherapeutics UK Limited 10 Norwich Street, London EC4A 1BD, United Kingdom |
EU/1/06/355 |
10.9.2015 |
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8.9.2015 |
Daklinza |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/14/939 |
10.9.2015 |
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8.9.2015 |
Ebixa |
H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark |
EU/1/02/219 |
10.9.2015 |
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8.9.2015 |
Enbrel |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/99/126 |
10.9.2015 |
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8.9.2015 |
Esbriet |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/11/667 |
10.9.2015 |
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8.9.2015 |
Extavia |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/08/454 |
10.9.2015 |
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8.9.2015 |
Grastofil |
Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland |
EU/1/13/877 |
10.9.2015 |
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8.9.2015 |
Hirobriz Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/594 |
10.9.2015 |
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8.9.2015 |
Plegridy |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/14/934 |
10.9.2015 |
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8.9.2015 |
Xofigo |
Bayer Pharma AG D-13342 Berlin, Deutschland |
EU/1/13/873 |
10.9.2015 |
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8.9.2015 |
Xyrem |
UCB Pharma Ltd 208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom |
EU/1/05/312 |
10.9.2015 |
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10.9.2015 |
ADCETRIS |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/12/794 |
14.9.2015 |
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14.9.2015 |
Betmiga |
Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland |
EU/1/12/809 |
16.9.2015 |
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14.9.2015 |
Elaprase |
Shire Human Genetic Therapies AB Svärdvägen 11D, SE-182 33 Danderyd, Sverige |
EU/1/06/365 |
16.9.2015 |
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14.9.2015 |
Quinsair |
Aptalis Pharma SAS Route de Bû, F-78550 Houdan, France |
EU/1/14/973 |
16.9.2015 |
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18.9.2015 |
Evoltra |
Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland |
EU/1/06/334 |
22.9.2015 |
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18.9.2015 |
Iclusig |
ARIAD Pharma Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom |
EU/1/13/839 |
22.9.2015 |
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18.9.2015 |
Imvanex |
Bavarian Nordic A/S Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark |
EU/1/13/855 |
22.9.2015 |
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18.9.2015 |
INOmax |
Linde Healthcare AB SE-181 81 Lidingö, Sverige |
EU/1/01/194 |
22.9.2015 |
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18.9.2015 |
Metalyse |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/00/169 |
22.9.2015 |
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18.9.2015 |
Perjeta |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/13/813 |
22.9.2015 |
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18.9.2015 |
Ruconest |
Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland |
EU/1/10/641 |
22.9.2015 |
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18.9.2015 |
Sebivo |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/07/388 |
22.9.2015 |
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18.9.2015 |
Spedra |
Menarini International Operations Luxembourg S.A. 1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg |
EU/1/13/841 |
22.9.2015 |
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18.9.2015 |
TachoSil |
Takeda Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich |
EU/1/04/277 |
22.9.2015 |
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18.9.2015 |
Visudyne |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/00/140 |
22.9.2015 |
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23.9.2015 |
Ilaris |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/564 |
28.10.2015 |
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23.9.2015 |
Inflectra |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom |
EU/1/13/854 |
25.9.2015 |
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23.9.2015 |
Toviaz |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/07/386 |
25.9.2015 |
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23.9.2015 |
Trajenta |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/11/707 |
25.9.2015 |
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23.9.2015 |
Viagra |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/98/077 |
28.9.2015 |
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30.9.2015 |
Arixtra |
Aspen Pharma Trading Limited 3016 Lake Drive Citywest Business Campus Dublin 24 Ireland |
EU/1/02/206 |
2.10.2015 |
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30.9.2015 |
Iasibon |
Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |
EU/1/10/659 |
2.10.2015 |
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30.9.2015 |
Sifrol |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/97/050 |
2.10.2015 |
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30.9.2015 |
Vibativ |
Clinigen Healthcare Limited Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom |
EU/1/11/705 |
2.10.2015 |
— Withdrawal of a marketing authorization (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
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23.9.2015 |
Biograstim |
AbZ-Pharma GmbH Graf-Arco-Straße 3, D-89079 Ulm, Deutschland |
EU/1/08/450 |
25.9.2015 |
— Issuing of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
INN (International Non-Proprietary Name) |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Pharmaceutical form |
ATC code (Anatomical Therapeutic Chemical Code) |
Date of notification |
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8.9.2015 |
FORTEKOR PLUS |
pimobendan/benazepril |
Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG 24 9NL, United Kingdom |
EU/2/15/185 |
Tablet |
QC09BX90 |
10.9.2015 |
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8.9.2015 |
Novaquin |
meloxicam |
Le Vet Beheer B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland |
EU/2/15/186 |
Oral suspension |
QM01AC06 |
10.9.2015 |
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8.9.2015 |
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 MAGYARORSZÁG |
EU/2/15/188 |
Suspension and solvent for suspension for injection |
QI01AD |
10.9.2015 |
— Modification of a marketing authorization (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted
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Date of the decision |
Name of the medicinal product |
Holder of the marketing authorization |
Number of the entry in the Community Register |
Date of notification |
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8.9.2015 |
BTVPUR AlSap 1 |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/10/112 |
10.9.2015 |
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8.9.2015 |
BTVPUR AlSap 1-8 |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/10/113 |
10.9.2015 |
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8.9.2015 |
Meloxoral |
Le Vet B.V. Wilgenweg 7, NL-3421 TV Oudewater, Nederland |
EU/2/10/111 |
10.9.2015 |
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18.9.2015 |
Onsior |
Elanco Europe Ltd Lilly House, Priestley Road, Basingstoke, Hampshire, RG 24 9NL, United Kingdom |
EU/2/08/089 |
22.9.2015 |
Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:
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The European Medicines Agency |
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7, Westferry Circus, Canary Wharf |
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UK — LONDON E14 4H |
(1) OJ L 136, 30.4.2004, p. 1.