Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 31 October 2014 (published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2014-11-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014428EN.01000101.xml










28.11.2014   


EN


Official Journal of the European Union


C 428/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 31 October 2014
(published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2014/C 428/01)
—   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 authorisation


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




21.10.2014


IMBRUVICA


Ibrutinib


Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België


EU/1/14/945


Capsule, hard


L01XE27


23.10.2014




—   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




1.10.2014


Apidra


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


EU/1/04/285


6.10.2014




1.10.2014


Bexsero


Novartis Vaccines and Diagnostics S.r.l.
Via Fiorentina, 1, 53100 Siena, Italia


EU/1/12/812


3.10.2014




1.10.2014


BYDUREON


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/11/696


3.10.2014




1.10.2014


ellaOne


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


EU/1/09/522


3.10.2014




1.10.2014


Iscover


Sanofi-Aventis groupe
54 rue La Boétie, F-75008 Paris, France


EU/1/98/070


3.10.2014




1.10.2014


Liprolog


Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland


EU/1/01/195


3.10.2014




1.10.2014


Plavix


Sanofi Clir SNC
54 rue La Boétie, F-75008 Paris, France


EU/1/98/069


3.10.2014




1.10.2014


Voriconazole Accord


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


EU/1/13/835


3.10.2014




1.10.2014


Zoledronic acid Teva


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


EU/1/12/771


3.10.2014




3.10.2014


Forxiga


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/795


7.10.2014




3.10.2014


Insuman


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


EU/1/97/030


7.10.2014




3.10.2014


Jakavi


Novartis Europharm Limited
Wimblehurst Road, Horsham, West Sussex RH12 5AB, United Kingdom


EU/1/12/773


7.10.2014




3.10.2014


Xigduo


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/13/900


7.10.2014




8.10.2014


Krystexxa


Crealta Pharmaceuticals Ireland Limited
Commercial House, Millbank Business Park, Lower Lucan Road, Lucan, Co.Dublin, Ireland


EU/1/12/810


13.10.2014




8.10.2014


Tarceva


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


EU/1/05/311


10.10.2014




8.10.2014


Yentreve


Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland


EU/1/04/280


10.10.2014




10.10.2014


Ariclaim


Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland


EU/1/04/283


14.10.2014




10.10.2014


Evoltra


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


EU/1/06/334


14.10.2014




10.10.2014


Keppra


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


EU/1/00/146


14.10.2014




10.10.2014


Translarna


PTC Therapeutics International Limited
77 Sir John Rogerson’s Quay, Dublin 2, Ireland


EU/1/13/902


14.10.2014




15.10.2014


Atosiban SUN


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


EU/1/13/852


17.10.2014




15.10.2014


Komboglyze


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/11/731


20.10.2014




15.10.2014


Onglyza


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/09/545


17.10.2014




15.10.2014


Xeristar


Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland


EU/1/04/297


17.10.2014




20.10.2014


Cymbalta


Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland


EU/1/04/296


23.10.2014




21.10.2014


Clopidogrel Teva Pharma


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


EU/1/09/561


23.10.2014




22.10.2014


Lyxumia


Sanofi-Aventis groupe
54 rue La Boétie, F-75008 Paris, France


EU/1/12/811


24.10.2014




22.10.2014


Nevirapine Teva


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


EU/1/09/598


24.10.2014




22.10.2014


Privigen


CSL Behring GmbH
Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland


EU/1/08/446


24.10.2014




27.10.2014


Abraxane


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


EU/1/07/428


29.10.2014




27.10.2014


BindRen


Mitsubishi Tanabe Pharma Europe Ltd
Dashwood House, 69 Old Broad Street, London EC2M 1QS United Kingdom


EU/1/12/804


29.10.2014




27.10.2014


Entacapone Teva


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


EU/1/10/665


29.10.2014




27.10.2014


Fasturtec


Sanofi-Aventis groupe
54 rue La Boétie, F-75008 Paris, France


EU/1/00/170


29.10.2014




27.10.2014


Hexyon


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


EU/1/13/829


29.10.2014




27.10.2014


Invanz


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


EU/1/02/216


29.10.2014




27.10.2014


Myclausen


Herbert J. Passauer GmbH & Co. KG
Stubenrauchstrasse 33, D-14167 Berlin, Deutschland


EU/1/10/647


29.10.2014




27.10.2014


Synflorix


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


EU/1/09/508


29.10.2014




27.10.2014


Vidaza


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


EU/1/08/488


29.10.2014




27.10.2014


Zavesca


Actelion Registration Ltd
Cheswick Tower, 13th floor, 389 Cheswick High Road, London W4 4AL, United Kingdom


EU/1/02/238


29.10.2014




30.10.2014


Elonva


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


EU/1/09/609


3.11.2014




30.10.2014


Hexacima


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


EU/1/13/828


3.11.2014




30.10.2014


Mycophenolate mofetil Teva


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


EU/1/07/439


4.11.2014




30.10.2014


Myfenax


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


EU/1/07/438


4.11.2014




30.10.2014


PREZISTA


Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België


EU/1/06/380


3.11.2014




30.10.2014


Zinforo


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/785


3.11.2014




—   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




1.10.2014


FLUENZ


MedImmune, LLC
Lagelandseweg 78, NL-6545 CG Nijmegen, Nederland


EU/1/10/661


3.10.2014




1.10.2014


Topotecan Eagle


Eagle Laboratories Limited
The Clock House, Station Approach, Marlow, Bucks SL7 1NT, United Kingdom


EU/1/11/744


3.10.2014




21.10.2014


Clopidogrel Teva Pharma B.V.


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


EU/1/10/649


23.10.2014




27.10.2014


Ipreziv


Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark


EU/1/11/735


29.10.2014




—   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




21.10.2014


Loxicom


Norbrook Laboratories Ltd
Station Works, Newry, Co. Down, BT35 6JP, United Kindgom


EU/2/08/090


23.10.2014




27.10.2014


Apoquel


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


EU/2/13/154


29.10.2014




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.