Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2015 to 30 June 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2015-07-31
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product








C_2015252EN.01000101.xml










31.7.2015   


EN


Official Journal of the European Union


C 252/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2015 to 30 June 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 252/01)
—   Issuing of a marketing authorization (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




10.6.2015


Gardasil 9


Human papillomavirus 9-valent vaccine (recombinant, adsorbed)


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


EU/1/15/1007


Suspension for injection


J07BM03


12.6.2015




19.6.2015


Duloxetine Mylan


Duloxetine


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


EU/1/15/1010


Gastro-resistant capsule, hard


N06AX21


24.6.2015




19.6.2015


Lixiana


Edoxaban


Daiichi Sankyo Europe GmbH
Zielstattstrasse 48, 81379 Munich, Deutschland


EU/1/15/993


Film-coated tablet


B01


23.6.2015




19.6.2015


Lumark


Lutetium, isotope of mass 177


IDB Radiopharmacy B.V.
Weverstraat 17, 5111 PV Baarle-Nassau, Nederland


EU/1/15/1013


Radiopharmaceutical precursor, solution


Pending


23.6.2015




19.6.2015


Opdivo


Nivolumab


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


EU/1/15/1014


Concentrate for solution for infusion


L01XC17


24.6.2015




19.6.2015


Pregabalin Sandoz


Pregabalin


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/15/1011


Capsule, hard


N03AX16


23.6.2015




19.6.2015


Pregabalin Sandoz GmbH


Pregabalin


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/15/1012


Capsule, hard


N03AX16


23.6.2015




25.6.2015


Aripiprazole Zentiva


Aripiprazole


Zentiva, k.s.
U Kabelovny 130, 102 37 Praha 10, Česká republika


EU/1/15/1009


Orodispersible tablet
Tablet


N05AX12


29.6.2015




25.6.2015


Pregabalin Mylan


Pregabalin


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


EU/1/15/997


Capsule, hard


N03AX16


30.6.2015




25.6.2015


Pregabalin Mylan Pharma


Pregabalin


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


EU/1/15/998


Capsule, hard


N03AX16


29.6.2015




30.6.2015


Aripiprazole Pharmathen


Aripiprazole


Pharmathen S.A.
6 Dervenakion, 15351 Pallini Attiki, Ελλάδα


EU/1/15/1005


Tablet


N05AX12


2.7.2015




—   Modification of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




2.6.2015


Mirvaso


Galderma International
Tour Europlaza, 20 avenue André Prothin, La Défense 4, La Défense Cedex 92927, France


EU/1/13/904


4.6.2015




2.6.2015


Optimark


Mallinckrodt Deutschland GmbH
Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland


EU/1/07/398


5.6.2015




5.6.2015


Kolbam


Retrophin Europe Limited
25/28 North Wall Quay, Dublin 1, Ireland


EU/1/13/895


9.6.2015




5.6.2015


Xelevia


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


EU/1/07/382


9.6.2015




10.6.2015


CANCIDAS


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


EU/1/01/196


12.6.2015




10.6.2015


Clopidogrel Krka d.d.


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


EU/1/09/562


12.6.2015




10.6.2015


Tesavel


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


EU/1/07/435


12.6.2015




11.6.2015


Adjupanrix


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


EU/1/09/578


16.6.2015




11.6.2015


IKERVIS


Santen Oy
Niittyhaankatu 20, FI-33720 Tampere, Suomi


EU/1/15/990


15.6.2015




11.6.2015


Insulatard


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


EU/1/02/233


15.6.2015




11.6.2015


Pramipexole Accord


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


EU/1/11/728


12.6.2015




11.6.2015


Protaphane


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


EU/1/02/234


15.6.2015




16.6.2015


Clopidogrel HCS


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


EU/1/10/651


18.6.2015




19.6.2015


Actos


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


EU/1/00/150


23.6.2015




19.6.2015


Actrapid


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


EU/1/02/230


23.6.2015




19.6.2015


APTIVUS


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


EU/1/05/315


23.6.2015




19.6.2015


AUBAGIO


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


EU/1/13/838


23.6.2015




19.6.2015


DuoTrav


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


EU/1/06/338


24.6.2015




19.6.2015


Eperzan


GlaxoSmithKline Trading Services Limited
Currabinny, Carrigaline, County Cork, Ireland


EU/1/13/908


23.6.2015




19.6.2015


Fabrazyme


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


EU/1/01/188


23.7.2015




19.6.2015


Glustin


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


EU/1/00/151


23.6.2015




19.6.2015


Leflunomide ratiopharm


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


EU/1/10/654


23.6.2015




19.6.2015


Orfadin


Swedish Orphan Biovitrum International AB
SE-112 76 Stockholm, Sverige


EU/1/04/303


23.6.2015




19.6.2015


Rasilamlo


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/11/686


24.6.2015




19.6.2015


Rasilez


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/07/405


24.6.2015




19.6.2015


SonoVue


Bracco International B.V.
Strawinskylaan 3051, NL-1077 ZX Amsterdam, Nederland


EU/1/01/177


23.6.2015




19.6.2015


Telmisartan Actavis


Actavis Group PTC ehf.
Reykjavíkurvegur 76-78, 220 Hafnarfjörður, Iceland


EU/1/10/639


23.6.2015




19.6.2015


Tyverb


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/07/440


24.6.2015




19.6.2015


VPRIV


Shire Pharmaceuticals Ireland Limited
5 River Walk, Citywest Business Campus, Dublin 24, Ireland


EU/1/10/646


23.6.2015




19.6.2015


Yervoy


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


EU/1/11/698


23.6.2015




19.6.2015


Yondelis


Pharma Mar S.A.
Avda de los Reyes 1, Polígono Industrial La Mina, E-28770 Colmenar Viejo, Madrid, España


EU/1/07/417


23.6.2015




22.6.2015


Cyanokit


SERB S.A.
Avenue Louise 480, 1050 Brussels, Belgique


EU/1/07/420


24.6.2015




22.6.2015


Fycompa


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


EU/1/12/776


24.6.2015




22.6.2015


JEVTANA


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


EU/1/11/676


24.6.2015




22.6.2015


Kivexa


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


EU/1/04/298


24.6.2015




22.6.2015


Kuvan


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


EU/1/08/481


24.6.2015




22.6.2015


Prevenar


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


EU/1/00/167


25.6.2015




22.6.2015


Rasilez HCT


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/08/491


24.6.2015




22.6.2015


Simponi


Janssen Biologics B.V.
Einsteinweg 101, NL-2333 CB Leiden, Nederland


EU/1/09/546


24.6.2015




22.6.2015


Stelara


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


EU/1/08/494


24.6.2015




22.6.2015


Xolair


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/05/319


24.6.2015




22.6.2015


Xtandi


Astellas Pharma Europe B.V.
Sylviusweg 62, NL-2333 BE Leiden, Nederland


EU/1/13/846


24.6.2015




25.6.2015


Ibandronic Acid Teva


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


EU/1/10/642


29.6.2015




25.6.2015


Xultophy


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


EU/1/14/947


29.6.2015




30.6.2015


Prolia


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


EU/1/10/618


2.7.2015




—   Withdrawal of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




25.6.2015


Rasilamlo


Novartis Europharm Limited
Frimley Business Park, Camberley GU16 7SR, United Kingdom


EU/1/11/686


29.6.2015




—   Issuing of a marketing authorization (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 authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




10.6.2015


Sileo


Dexmedetomidine hydrochloride


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/2/15/181


Oromucosal gel


QN05CM18


12.6.2015




—   Modification of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




5.6.2015


Bovilis BTV8


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


EU/2/10/106


9.6.2015




5.6.2015


Equisolon


Le Vet B.V.
Wilgenweg 7, NL-3421 TV Oudewater, Nederland


EU/2/14/161


9.6.2015




5.6.2015


Recuvyra


Eli Lilly and Company Limited
Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom


EU/2/11/127


9.6.2015




10.6.2015


Cerenia


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


EU/2/06/062


12.6.2015




10.6.2015


Equilis Te


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


EU/2/05/055


12.6.2015




10.6.2015


Kexxtone


Eli Lilly and Company Limited
Elanco Animal Health, Lilly House, Priestley Road, Basingstoke, Hampshire RG24 9NL, United Kingdom


EU/2/12/145


12.6.2015




10.6.2015


Previcox


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


EU/2/04/045


12.6.2015




11.6.2015


Prac-Tic


Novartis Sanidad Animal S.L.
Calle de la Marina, 206, E-08013 Barcelona, España


EU/2/06/066


12.6.2015




19.6.2015


Profender


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/05/054


23.6.2015




30.6.2015


Rhiniseng


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


EU/2/10/109


2.7.2015




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.