Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 2014 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2014-08-29
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2014290EN.01000101.xml










29.8.2014   


EN


Official Journal of the European Union


C 290/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2014 to 31 July 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 290/01
—   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




18.7.2014


Envarsus


tacrolimus


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


EU/1/14/935


Prolonged-release tablet


L04AD02


22.7.2014




18.7.2014


Plegridy


peginterferon beta-1a


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


EU/1/14/934


Solution for injection


L03AB13


23.7.2014




18.7.2014


Simbrinza


Brinzolamide/Brimonidine tartrate


Alcon Laboratories (UK) Ltd.
Frimley Business Park, Frimley, Camberley, Surrey, GU16 7SR, United Kingdom


EU/1/14/933


Ear drops, suspension


Pending


23.7.2014




22.7.2014


Nuwiq


simoctocog alfa


Octapharma AB
Elersvägen 40 Stockholm 11275 Sweden


EU/1/14/936


Powder and solvent for solution for injection


B02BD02


24.7.2014




23.7.2014


Gazyvaro


obinutuzumab


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


EU/1/14/937


Concentrate for solution for infusion


L01


24.7.2014




31.7.2014


Translarna


ataluren


PTC Therapeutics, Limited
Lakeside House, Office G33a, 1 Furzeground Way, Stockley Park E. Uxbridge, UB11 1BD, United Kingdom


EU/1/13/902


Granules for oral suspension


Pending


5.8.2014




—   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




4.7.2014


Masican


AB Science S.A.
3 avenue George V, F-75008 Paris, France


 


8.7.2014




23.7.2014


Masiviera


AB Science S.A.
3 avenue George V, F-75008 Paris, France


 


24.7.2014




—   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




4.7.2014


Copalia HCT


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


EU/1/09/575


11.7.2014




4.7.2014


Dafiro HCT


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


EU/1/09/574


11.7.2014




4.7.2014


Efavirenz Teva


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


EU/1/11/742


9.7.2014




4.7.2014


Flebogamma DIF


Instituto Grifols, S.A.
Can Guasch 2, Parets del Vallès, E-08150 Barcelona, Espaňa


EU/1/07/404


8.7.2014




4.7.2014


Fuzeon


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


EU/1/03/252


8.7.2014




4.7.2014


Optison


GE Healthcare AS
Nycoveien 1-2, P.O.Box 4220 Nydalen, N-0401 OSLO, Norge


EU/1/98/065


8.7.2014




11.7.2014


Riluzole Zentiva


Aventis Pharma S.A.
20 avenue Raymond Aron, F-92165 Antony CEDEX, France


EU/1/12/768


15.7.2014




11.7.2014


Rivastigmine HEXAL


Hexal AG
Industriestrasse 25, D-83607 Holzkirchen, Deutschland


EU/1/09/589


15.7.2014




11.7.2014


Rivastigmine Sandoz


Sandoz Pharmaceuticals GmbH
Raiffeisenstraße 11, D-83607 Holzkirchen, Deutschland


EU/1/09/599


15.7.2014




14.7.2014


Docetaxel Teva


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


EU/1/09/611


17.7.2014




14.7.2014


Viagra


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


EU/1/98/077


16.7.2014




18.7.2014


Adjupanrix


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


EU/1/09/578


22.7.2014




18.7.2014


CellCept


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


EU/1/96/005


22.7.2014




18.7.2014


Dacogen


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


EU/1/12/792


23.7.2014




18.7.2014


Glivec


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


EU/1/01/198


22.7.2014




18.7.2014


Irbesartan Teva


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


EU/1/09/576


23.7.2014




18.7.2014


Nimenrix


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


EU/1/12/767


22.7.2014




18.7.2014


Omnitrope


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/06/332


22.7.2014




18.7.2014


Onglyza


Bristol-Myers Squibb/AstraZeneca EEIG
Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom


EU/1/09/545


22.7.2014




18.7.2014


SANCUSO


ProStrakan Limited
Galabank Business Park, Galashiels TD1 1QH, United Kingdom


EU/1/12/766


23.7.2014




18.7.2014


Savene


Clinigen Healthcare Limited
Pitcairn House, Crown Square, First Avenue, Burton-on-Trent, Staffordshire DE14 2WW, United Kingdom


EU/1/06/350


22.7.2014




18.7.2014


Tasmar


Meda AB
Pipers väg 2A, S-170 09 Solna, Sverige


EU/1/97/044


22.7.2014




18.7.2014


Temomedac


medac Gesellschaft für klinische Spezialpräparate mbH
Fehlandtstraße 3, D-20354 Hamburg, Deutschland


EU/1/09/605


22.7.2014




18.7.2014


Tesavel


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


EU/1/07/435


22.7.2014




18.7.2014


Ventavis


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/03/255


22.7.2014




18.7.2014


Votubia


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


EU/1/11/710


23.7.2014




18.7.2014


Xagrid


Shire Pharmaceutical Contracts Ltd
Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom


EU/1/04/295


23.7.2014




18.7.2014


Zytiga


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


EU/1/11/714


23.7.2014




22.7.2014


Rapiscan


Rapidscan Pharma Solutions EU Ltd.
Regent's Place, 338 Euston Road, London NW1 3BT, United Kingdom


EU/1/10/643


24.7.2014




23.7.2014


Fabrazyme


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


EU/1/01/188


24.7.2014




28.7.2014


Arzerra


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


EU/1/10/625


30.7.2014




28.7.2014


Byetta


AstraZeneca AB
S-151 85 Södertälje, Sverige


EU/1/06/362


30.7.2014




28.7.2014


Eliquis


Bristol-Myers Squibb/Pfizer EEIG
Bristol-Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom


EU/1/11/691


30.7.2014




28.7.2014


Enbrel


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


EU/1/99/126


29.7.2014




28.7.2014


Kalydeco


Vertex Pharmaceuticals (U.K.) Limited
Cardinal Point, Park Road, Rickmansworth, Herts WD3 1RE, United Kingdom


EU/1/12/782


30.7.2014




28.7.2014


Menveo


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


EU/1/10/614


29.7.2014




28.7.2014


Olanzapine Apotex


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


EU/1/10/635


29.7.2014




28.7.2014


Pandemrix


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


EU/1/08/452


30.7.2014




28.7.2014


Stivarga


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/13/858


30.7.2014




28.7.2014


Xelevia


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


EU/1/07/382


29.7.2014




31.7.2014


Avastin


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


EU/1/04/300


4.8.2014




31.7.2014


BYDUREON


Bristol-Myers Squibb/AstraZeneca EEIG
Bristol Myers Squibb House, Uxbridge Business Park, Sanderson Road, Uxbridge, Middlesex UB8 1DH, United Kingdom


EU/1/11/696


4.8.2014




31.7.2014


Colobreathe


Forest Laboratories UK Ltd
Riverbridge House, Anchor Boulevard, Crossways Business Park, Dartford, Kent DA2 6SL, United Kingdom


EU/1/11/747


1.8.2014




31.7.2014


Xarelto


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/08/472


4.8.2014




—   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




8.7.2014


Olanzapine Cipla


Cipla (EU) Limited
Hillbrow House, Hillbrow Road, Esher, Surrey KT10 9NW, United Kingdom


EU/1/07/426


10.7.2014




31.7.2014


Doribax


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


EU/1/08/467


4.8.2014




31.7.2014


IOA


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


EU/1/11/689


4.8.2014




—   Issuing of a marketing authorisation (Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (2)): 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




4.7.2014


ERYSENG


Inactivated Erysipelothrix rhusiopathiae, strain R32E11


Laboratorios Hipra, S.A.
Avda. La Selva, 135, E-17170- Amer (Girona), España


EU/2/14/166


Suspension for injection


QI09AB03


8.7.2014




4.7.2014


Versican Plus DHPPi


Canine distemper virus, canine adenovirus, canine parvovirus, canine parainfluenza type 2 virus


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


EU/2/14/169


Lyophilisate and solvent for suspension for injection


QI07AD04


8.7.2014




4.7.2014


Versican Plus Pi


Canine parainfluenza type 2 virus


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


EU/2/14/168


Lyophilisate and solvent for suspension for injection


QI07AD08


8.7.2014




8.7.2014


ERYSENG PARVO


Inactivated porcine parvovirus, strain NADL-2/Inactivated Erysipelothrix rhusiopathiae, strain R32E11


Laboratorios Hipra, S.A.
Avda. La Selva, 135, E-17170- Amer (Girona), España


EU/2/14/167


Suspension for injection


QI09AL01


10.7.2014




31.7.2014


Osurnia


terbinafine/florfenicol/betamethasone acetate


Novartis Santé Animale S.A.S.
10 Rue Blériot, 92 500 Rueil-Malmaison, France


EU/2/14/170


Ear gel


QS02CA90


1.8.2014




31.7.2014


Versican Plus L4


Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089
Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090
Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091
Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088


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


EU/2/14/171


Suspension for injection


QI07AB01


5.8.2014




31.7.2014


Versican Plus Pi/L4


Canine parainfluenza type 2 virus
Leptospira interrogans serogroup Icterohaemorrhagiae, serovar Icterohaemorrhagiae strain MSLB 1089
Leptospira interrogans serogroup Canicola, serovar Canicola, strain MSLB 1090
Leptospira kirschneri serogroup Grippotyphosa, serovar Grippotyphosa, strain MSLB 1091
Leptospira interrogans serogroup Australis, serovar Bratislava, strain MSLB 1088


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


EU/2/14/172


Lyophilisate for suspension for spray vaccination


QI07AI08


4.8.2014




—   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




8.7.2014


Draxxin


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


EU/2/03/041


10.7.2014




8.7.2014


SevoFlo


Abbott Laboratories Ltd
Abbott House, Vanwall Business Park, Vanwall Road, Maidenhead SL6 4XE, United Kingdom


EU/2/02/035


10.7.2014




11.7.2014


ProteqFlu


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


EU/2/03/037


15.7.2014




11.7.2014


ProteqFlu-Te


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


EU/2/03/038


15.7.2014




28.7.2014


Poulvac E. coli


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


EU/2/12/140


29.7.2014




31.7.2014


Palladia


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


EU/2/09/100


4.8.2014




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, 30.4.2004, p. 1 .

(2)  OJ L 136, 30.4.2004, p. 1.