Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2015 to 28 February 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2015-03-27
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2015104EN.01000101.xml










27.3.2015   


EN


Official Journal of the European Union


C 104/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 February 2015 to 28 February 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 104/01)
—   Issuing of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted













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




17.2.2015


Holoclar


Ex vivo expanded autologous human corneal epithelial cells containing stem cells


Chiesi Farmaceutici S.P.A.
Via Palermo 26/A, 43122 Parma, Italia


EU/1/14/987


Living tissue equivalent


S01XA19


19.2.2015




17.2.2015


Tyverb


lapatinib


Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom


EU/1/07/440


Film-coated tablet


L01XE07


19.2.2015




19.2.2015


Clopidogrel ratiopharm


clopidogrel


Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland


EU/1/14/975


Film-coated tablet


B01AC04


24.2.2015




19.2.2015


Xydalba


Dalbavancin


Durata Therapeutics International B.V.
Spaces Zuidas II, Barbara Strozzilaan 101, 1083 HN Amsterdam, Nederland


EU/1/14/986


Powder for concentrate for solution for infusion


J01XA04


23.2.2015




24.2.2015


Xadago


safinamide


Zambon S.p.A.
Via Lillo del Duca 10, 20091 Bresso (MI), Italia


EU/1/14/984


Film-coated tablet


Pending


26.2.2015




26.2.2015


Tasermity


sevelamer hydrochloride


Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, Nederland


EU/1/14/953


Film-coated tablet


V03AE02


2.3.2015




—   Modification of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




3.2.2015


Levetiracetam Teva


Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland


EU/1/11/701


5.2.2015




3.2.2015


Pergoveris


Merck Serono Europe Limited
56, Marsh Wall, London E14 9TP, United Kingdom


EU/1/07/396


6.2.2015




6.2.2015


Adenuric


Menarini International Operations Luxembourg S.A.
1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg


EU/1/08/447


10.2.2015




6.2.2015


Bridion


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/08/466


10.2.2015




6.2.2015


Ceplene


Meda AB
Box 906, SE-170 09 Solna, Sverige


EU/1/08/477


10.2.2015




6.2.2015


Filgrastim Hexal


Hexal AG
Industriestrasse 25, D-83607 Holzkirchen, Deutschland


EU/1/08/496


10.2.2015




6.2.2015


Firazyr


Shire Orphan Therapies GmbH
Friedrichstraße 149, D-10117 Berlin, Deutschland


EU/1/08/461


10.2.2015




6.2.2015


Herceptin


Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/00/145


10.2.2015




6.2.2015


Leflunomide ratiopharm


ratiopharm GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland


EU/1/10/654


10.2.2015




6.2.2015


Levetiracetam SUN


Sun Pharmaceutical Industries Europe BV
Polarisavenue 87, NL-2132 JH Hoofddorp, Nederland


EU/1/11/741


10.2.2015




6.2.2015


Opgenra


Olympus Biotech International Limited
40 Upper Mount Street, Dublin 2, Ireland


EU/1/08/489


10.2.2015




6.2.2015


Raloxifene Teva


Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland


EU/1/10/627


11.2.2015




6.2.2015


Vimpat


UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België


EU/1/08/470


10.2.2015




6.2.2015


Zarzio


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/08/495


10.2.2015




10.2.2015


Replagal


Shire Human Genetic Therapies AB
Svärdvägen 11D, SE-182 33 Danderyd, Sverige


EU/1/01/189


12.2.2015




10.2.2015


Telmisartan Teva


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/09/610


12.2.2015




10.2.2015


Telmisartan Teva Pharma


Teva B.V.
Swensweg 5, 2031 GA Haarlem, Nederland


EU/1/11/719


12.2.2015




10.2.2015


Tybost


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/872


12.2.2015




11.2.2015


Champix


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/06/360


13.2.2015




11.2.2015


HBVAXPRO


Sanofi Pasteur MSD, SNC
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/01/183


13.2.2015




11.2.2015


Hepsera


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/03/251


13.2.2015




11.2.2015


Olanzapine Apotex


Apotex Europe B.V.
Darwinweg 20, NL-2333 CR Leiden, Nederland


EU/1/10/635


16.2.2015




11.2.2015


Ribavirin Mylan


Generics [UK] Limited
Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom


EU/1/10/634


13.2.2015




11.2.2015


Somavert


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/02/240


13.2.2015




11.2.2015


Tyverb


Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom


EU/1/07/440


13.2.2015




11.2.2015


Vitekta


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/883


13.2.2015




11.2.2015


Zoledronic acid Hospira


Hospira UK Limited
Queensway, Royal Leamington Spa, Warwickshire CV31 3RW, United Kingdom


EU/1/12/800


13.2.2015




12.2.2015


Esbriet


Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom


EU/1/11/667


16.2.2015




17.2.2015


Arzerra


Glaxo Group Ltd
980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom


EU/1/10/625


19.2.2015




17.2.2015


Lantus


Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland


EU/1/00/134


19.2.2015




17.2.2015


Oprymea


Krka, d. d., Novo Mesto
Šmarješka cesta 6, 8501 Novo mesto, Slovenija


EU/1/08/469


19.2.2015




17.2.2015


Optisulin


Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main, Deutschland


EU/1/00/133


19.2.2015




17.2.2015


Renagel


Genzyme Europe B.V.
Gooimeer 10, NL-1411 DD Naarden, Nederland


EU/1/99/123


19.2.2015




17.2.2015


Sutent


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/06/347


19.2.2015




17.2.2015


Vidaza


Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom


EU/1/08/488


19.2.2015




19.2.2015


Abilify


Otsuka Pharmaceutical Europe Ltd.
Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom


EU/1/04/276


23.2.2015




19.2.2015


EVARREST


Omrix Biopharmaceuticals N.V.
Leonardo Da Vincilaan 15, B-1831 Diegem, België


EU/1/13/868


23.2.2015




19.2.2015


Fertavid


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/09/510


23.2.2015




19.2.2015


Memantine Accord


Accord Healthcare Limited
Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom


EU/1/13/880


23.2.2015




19.2.2015


Mixtard


Novo Nordisk A/S
Novo Allé, DK-2880 Bagsvaerd, Danmark


EU/1/02/231


23.2.2015




19.2.2015


NeuroBloc


Eisai Limited
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire AL10 9SN, United Kingdom


EU/1/00/166


23.2.2015




19.2.2015


Revlimid


Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom


EU/1/07/391


23.2.2015




19.2.2015


Reyataz


Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom


EU/1/03/267


23.2.2015




19.2.2015


RotaTeq


Sanofi Pasteur MSD, SNC
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/06/348


23.2.2015




19.2.2015


Victrelis


Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom


EU/1/11/704


23.2.2015




24.2.2015


Aloxi


Helsinn Birex Pharmaceuticals Ltd
Damastown, Mulhuddart, Dublin 15, Ireland


EU/1/04/306


26.2.2015




24.2.2015


Eylea


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/12/797


26.2.2015




24.2.2015


Hexacima


Sanofi Pasteur SA
2 avenue Pont Pasteur, F-69007 Lyon, France


EU/1/13/828


26.2.2015




24.2.2015


Hexyon


Sanofi Pasteur MSD, SNC
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/13/829


26.2.2015




26.2.2015


Abraxane


Celgene Europe Limited
1 Longwalk Road, Stockley Park, Uxbridge UB11 1DB, United Kingdom


EU/1/07/428


2.3.2015




26.2.2015


Bosulif


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/13/818


2.3.2015




26.2.2015


Brimica Genuair


Almirall, S.A.
Ronda General Mitre, 151, E-08022 Barcelona, España


EU/1/14/963


2.3.2015




26.2.2015


Duaklir Genuair


Almirall, S.A.
Ronda General Mitre, 151, E-08022 Barcelona, España


EU/1/14/964


2.3.2015




26.2.2015


Epivir


ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom


EU/1/96/015


2.3.2015




26.2.2015


Lysodren


Laboratoire HRA Pharma
15 rue Béranger, F-75003 Paris, France


EU/1/04/273


2.3.2015




26.2.2015


Prevenar 13


Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom


EU/1/09/590


2.3.2015




26.2.2015


Yellox


PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c 17000 Praha 7 Česká republika


EU/1/11/692


2.3.2015




26.2.2015


Ziagen


ViiV Healthcare UK Limited
980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom


EU/1/99/112


2.3.2015




—   Withdrawal of a marketing authorisation (Article 13 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)









Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




11.2.2015


Pumarix


GlaxoSmithKline Biologicals S.A.
rue de l'Institut 89, 1330 Rixensart, Belgique


EU/1/10/664


13.2.2015




—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted













Date of the decision


Name of the medicinal product


INN (International Non-Proprietary Name)


Holder of the marketing authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




6.2.2015


Zulvac SBV


Inactivated Schmallenberg virus, strain BH80/11-4


Zoetis Belgium S.A.
Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique


EU/2/14/178


Suspension for injection


QI02AA


10.2.2015




—   Modification of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council): Accepted










Date of the decision


Name of the medicinal product


Holder of the marketing authorisation


Number of the entry in the Community Register


Date of notification




17.2.2015


BTVPUR AlSap 1


Merial
29 avenue Tony Garnier, F-69007 Lyon, France


EU/2/10/112


19.2.2015




17.2.2015


BTVPUR AlSap 1-8


Merial
29 avenue Tony Garnier, F-69007 Lyon, France


EU/2/10/113


19.2.2015




19.2.2015


Nobivac Myxo-RHD


Intervet International B.V.
Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland


EU/2/11/132


23.2.2015




26.2.2015


CERTIFECT


Merial
29 avenue Tony Garnier, F-69007 Lyon, France


EU/2/11/125


2.3.2015




26.2.2015


ECOPORC SHIGA


IDT Biologika GmbH
Am Pharmapark, D-06861 Dessau-Rosslau, Deutschland


EU/2/13/149


2.3.2015




Anyone wishing to consult the public assessment report on the medicinal products in question and the decisions relating thereto is invited to contact:





The European Medicines Agency




30, Churchill Place, Canary Wharf




UK — LONDON E14 5EU






(1)  OJ L 136, 30.4.2004, p. 1.