Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2014 to 31 August 2014 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2014-09-26
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014337EN.01000401.xml










26.9.2014   


EN


Official Journal of the European Union


C 337/4





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 August 2014 to 31 August 2014
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
2014/C 337/02
—   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




22.8.2014


Daklinza


daclatasvir


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


EU/1/14/939


Film-coated tablet


J05AX


26.8.2014




22.8.2014


Vizamyl


flutemetamol (18F)


GE Healthcare Ltd
Amersham Place Little Chalfont Buckinghamshire HP7 9NA UNITED KINGDOM


EU/1/14/941


Solution for injection


V09AX04


26.8.2014




26.8.2014


Velphoro


mixture of polynuclear iron (iii)-oxyhydroxide, sucrose and starches


Vifor Fresenius Medical Care Renal Pharma France
7-13 boulevard Paul-Emile Victor, 92521 Neuilly-sur-Seine, France


EU/1/14/943


Chewable tablet


V03AE05


28.8.2014




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










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




5.8.2014


Folcepri


Endocyte Europe B.V.
Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland


—


7.8.2014




5.8.2014


Neocepri


Endocyte Europe B.V.
Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland


—


7.8.2014




5.8.2014


Reasanz


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


—


20.8.2014




5.8.2014


Vynfinit


Endocyte Europe B.V.
Prins Bernhardplein 200, NL-1097 JB Amsterdam, Nederland


—


7.8.2014




19.8.2014


Nerventra


Teva Pharma GmbH
Graf-Arco-Straße 3, D-89079 Ulm, Deutschland


—


21.8.2014




—   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




6.8.2014


APTIVUS


Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland


EU/1/05/315


8.8.2014




6.8.2014


Eylea


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/12/797


8.8.2014




6.8.2014


Fluenz Tetra


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


EU/1/13/887


8.8.2014




6.8.2014


IDflu


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


EU/1/08/507


8.8.2014




6.8.2014


Intanza


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


EU/1/08/505


8.8.2014




6.8.2014


Olazax Disperzi


Glenmark Pharmaceuticals s.r.o.
City Tower, Hvězdova 1716/2b, CZ-14078 Praha 4, Česká republika


EU/1/09/592


8.8.2014




6.8.2014


Optaflu


Novartis Vaccines and Diagnostics GmbH
Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland


EU/1/07/394


8.8.2014




6.8.2014


Sprycel


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


EU/1/06/363


8.8.2014




19.8.2014


Aerius


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


EU/1/00/160


21.8.2014




19.8.2014


Azomyr


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


EU/1/00/157


21.8.2014




19.8.2014


Capecitabine SUN


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


EU/1/13/831


21.8.2014




19.8.2014


Neoclarityn


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


EU/1/00/161


21.8.2014




19.8.2014


Olanzapine Glenmark


Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue, Kenton, Harrow, Middlesex, HA3 0BU, United Kingdom


EU/1/09/587


21.8.2014




19.8.2014


Olanzapine Glenmark Europe


Glenmark Pharmaceuticals Europe Limited
Laxmi House, 2B Draycott Avenue, Kenton, Harrow, Middlesex, HA3 0BU, United Kingdom


EU/1/09/588


21.8.2014




19.8.2014


Olanzapine Mylan


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


EU/1/08/475


21.8.2014




19.8.2014


Panretin


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


EU/1/00/149


21.8.2014




19.8.2014


Retacrit


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


EU/1/07/431


21.8.2014




19.8.2014


Ristaben


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


EU/1/10/621


21.8.2014




19.8.2014


Rivastigmine 1 A Pharma


1 A Pharma GmbH
Keltenring 1 + 3, D-82041 Oberhaching, Deutschland


EU/1/09/585


21.8.2014




22.8.2014


ADCETRIS


Takeda Pharma A/S
Langebjerg 1, DK-4000 Roskilde, Danmark


EU/1/12/794


26.8.2014




22.8.2014


Baraclude


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


EU/1/06/343


26.8.2014




22.8.2014


ChondroCelect


TiGenix NV
Romeinse straat 12/2, B-3001 Leuven, België


EU/1/09/563


26.8.2014




22.8.2014


Clopidogrel HCS


HCS bvba
H. Kennisstraat 53, B-2650 Edegem, België


EU/1/10/651


27.8.2014




22.8.2014


Corlentor


Les Laboratoires Servier
50 rue Carnot, F-92284 Suresnes CEDEX, France


EU/1/05/317


26.8.2014




22.8.2014


Dasselta


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


EU/1/11/739


26.8.2014




22.8.2014


Elonva


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


EU/1/09/609


26.8.2014




22.8.2014


Enyglid


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


EU/1/09/580


26.8.2014




22.8.2014


Imvanex


Bavarian Nordic A/S
Hejreskovvej 10a, DK-3490 Kvistgaard, Danmark


EU/1/13/855


26.8.2014




22.8.2014


Isentress


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


EU/1/07/436


26.8.2014




22.8.2014


Olazax


Glenmark Pharmaceuticals s.r.o.
Hvězdova 1716/2b, 140 78 Praha 4, Česká republika


EU/1/09/597


26.8.2014




22.8.2014


Procoralan


Les Laboratoires Servier
50 rue Carnot, F-92284 Suresnes CEDEX, France


EU/1/05/316


26.8.2014




22.8.2014


Repaglinide Krka


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


EU/1/09/579


26.8.2014




22.8.2014


Synagis


AbbVie Ltd
Maidenhead, SL6 4XE, United Kingdom


EU/1/99/117


26.8.2014




22.8.2014


Teysuno


Nordic Group B.V.
Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland


EU/1/11/669


26.8.2014




22.8.2014


Victrelis


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


EU/1/11/704


26.8.2014




22.8.2014


XALKORI


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


EU/1/12/793


26.8.2014




26.8.2014


Aerinaze


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


EU/1/07/399


28.8.2014




26.8.2014


Arixtra


Aspen Pharma Trading Limited
3016 Lake Drive Citywest Business Campus Dublin 24 Ireland


EU/1/02/206


28.8.2014




26.8.2014


Avonex


Biogen Idec Limited
Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom


EU/1/97/033


28.8.2014




26.8.2014


BeneFIX


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


EU/1/97/047


28.8.2014




26.8.2014


Betaferon


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/95/003


28.8.2014




26.8.2014


Biopoin


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


EU/1/09/565


28.8.2014




26.8.2014


Busilvex


Pierre Fabre Médicament
45 place Abel Gance, F-92654 Boulogne-Billancourt CEDEX, France


EU/1/03/254


28.8.2014




26.8.2014


Ecalta


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


EU/1/07/416


28.8.2014




26.8.2014


Eylea


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/12/797


28.8.2014




26.8.2014


Fareston


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/1/96/004


28.8.2014




26.8.2014


Imnovid


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


EU/1/13/850


28.8.2014




26.8.2014


MACI


Aastrom Biosciences DK ApS
Oliefabriksvej 45, 2770 Kastrup, Danmark


EU/1/13/847


28.8.2014




26.8.2014


Marixino


Consilient Health Ltd
5th floor, Beaux Lane House, Mercer Street Lower, Dublin 2, Ireland


EU/1/13/820


28.8.2014




26.8.2014


Nevirapine Teva


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


EU/1/09/598


28.8.2014




26.8.2014


Ozurdex


Allergan Pharmaceuticals Ireland
Castlebar Road, Westport, County Mayo, Ireland


EU/1/10/638


28.8.2014




26.8.2014


Prolia


Amgen Europe B.V.
Minervum 7061, NL-4817 ZK Breda, Nederland


EU/1/10/618


28.8.2014




26.8.2014


Rebif


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


EU/1/98/063


28.8.2014




26.8.2014


Scintimun


CIS bio international
Boîte postale 32, F-91192 Gif-sur-Yvette, France


EU/1/09/602


28.8.2014




26.8.2014


Temozolomide Teva


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


EU/1/09/606


28.8.2014




26.8.2014


Xenical


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


EU/1/98/071


28.8.2014




26.8.2014


Zalasta


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


EU/1/07/415


28.8.2014




27.8.2014


Clopidogrel BGR


Laboratoires BIOGARAN
15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France


EU/1/09/558


29.8.2014




—   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




19.8.2014


Rivastigmine 3M Health Care Ltd.


3M Health Care Limited
1 Morley Street, Loughborough, Leicestershire, LE11 1EP United Kingdom


EU/1/14/911


21.8.2014




22.8.2014


Vistide


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/97/037


26.8.2014




—   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




5.8.2014


Activyl Tick Plus


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


EU/2/11/137


7.8.2014




19.8.2014


Zolvix


Novartis Healthcare A/S
Edvard Thomsens Vej 14, DK-2300 København S, Danmark


EU/2/09/101


21.8.2014




26.8.2014


Cortavance


VIRBAC S.A.
1ère Avenue — 2065 m — L.I.D., F-06516 Carros CEDEX, France


EU/2/06/069


28.8.2014




26.8.2014


Naxcel


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


EU/2/05/053


28.8.2014




26.8.2014


Procox


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/11/123


28.8.2014




26.8.2014


Slentrol


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


EU/2/07/071


28.8.2014




26.8.2014


Stronghold


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


EU/2/99/014


28.8.2014




27.8.2014


Convenia


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


EU/2/06/059


29.8.2014




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, 30.4.04, p. 1.