Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2017 to 31 May 2017 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2017-06-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug








C_2017208EN.01000101.xml










30.6.2017   


EN


Official Journal of the European Union


C 208/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 May 2017 to 31 May 2017
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2017/C 208/01)






—



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




8.5.2017


Dinutuximab beta Apeiron


dinutuximab beta


APEIRON Biologics AG
Campus Vienna Biocenter 5, A-1030 Wien, Österreich


EU/1/17/1191


Concentrate for solution for infusion


L01XC


11.5.2017




22.5.2017


Axumin


fluciclovine (18F)


Blue Earth Diagnostics Ltd
215 Euston Road, London NW1 2BE, United Kingdom


EU/1/17/1186


Solution for injection


V09IX12


24.5.2017




22.5.2017


Fampyra


fampridine


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


EU/1/11/699


Prolonged-release tablet


N07XX07


24.5.2017




22.5.2017


Ivabradine Accord


ivabradine


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


EU/1/17/1190


Film-coated tablet


C01EB17


24.5.2017




24.5.2017


Trumenba


meningococcal group B vaccine (recombinant, adsorbed)


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


EU/1/17/1187


Suspension for injection


J07AH09


30.5.2017




30.5.2017


Brineura


cerliponase alfa


BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, Ireland


EU/1/17/1192


Solution for infusion


A16AB


1.6.2017




30.5.2017


Spinraza


nusinersen


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


EU/1/17/1188


Solution for injection


Pending


1.6.2017










—



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




2.5.2017


Adempas


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/13/907


4.5.2017




2.5.2017


Emtricitabine/Tenofovir disoproxil Krka


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


EU/1/16/1151


4.5.2017




2.5.2017


KEYTRUDA


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


EU/1/15/1024


4.5.2017




2.5.2017


Prolia


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


EU/1/10/618


4.5.2017




2.5.2017


Xenical


CHEPLAPHARM Arzneimittel GmbH
Ziegelhof 24, 17489 Greifswald, Deutschland


EU/1/98/071


4.5.2017




4.5.2017


Ebymect


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/15/1051


8.5.2017




4.5.2017


Imatinib Accord


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


EU/1/13/845


8.5.2017




4.5.2017


Qutenza


Grünenthal GmbH
Zieglerstrasse 6, D-52078, Aachen, Deutschland


EU/1/09/524


8.5.2017




8.5.2017


Akynzeo


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


EU/1/15/1001


11.5.2017




8.5.2017


Glivec


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


EU/1/01/198


11.5.2017




8.5.2017


Ivabradine Anpharm


ANPHARM Przedsiębiorstwo Farmaceutyczne S.A.
ul. Annopol 6B, 03-236 Warszawa, Polska


EU/1/15/1041


11.5.2017




8.5.2017


Pergoveris


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


EU/1/07/396


11.5.2017




8.5.2017


Rasagiline Mylan


Mylan S.A.S
117 allée des Parcs, F-69800 Saint Priest, France


EU/1/16/1090


11.5.2017




8.5.2017


Simbrinza


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


EU/1/14/933


11.5.2017




8.5.2017


Xarelto


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/08/472


11.5.2017




16.5.2017


Azarga


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


EU/1/08/482


18.5.2017




16.5.2017


DuoTrav


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


EU/1/06/338


18.5.2017




16.5.2017


Emadine


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


EU/1/98/095


18.5.2017




16.5.2017


Feraccru


Shield TX (UK) Limited
Gateshead Quays, NE8 3DF, United Kingdom


EU/1/15/1075


18.5.2017




16.5.2017


Lysodren


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


EU/1/04/273


18.5.2017




16.5.2017


Mabthera


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


EU/1/98/067


18.5.2017




16.5.2017


Marixino


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


EU/1/13/820


18.5.2017




16.5.2017


Nevanac


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


EU/1/07/433


18.5.2017




16.5.2017


Obizur


Baxalta Innovations GmbH
Industriestrasse 67, A-1221 Wien, Österreich


EU/1/15/1035


18.5.2017




16.5.2017


Tygacil


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


EU/1/06/336


18.5.2017




18.5.2017


Brilique


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/10/655


23.5.2017




18.5.2017


Desloratadine Actavis


Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland


EU/1/11/745


23.5.2017




18.5.2017


Desloratadine ratiopharm


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


EU/1/11/746


23.5.2017




18.5.2017


Fampyra


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


EU/1/11/699


23.5.2017




18.5.2017


Ratiograstim


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


EU/1/08/444


23.5.2017




18.5.2017


Taxotere


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


EU/1/95/002


23.5.2017




18.5.2017


Zalasta


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


EU/1/07/415


22.5.2017




18.5.2017


Zelboraf


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


EU/1/12/751


23.5.2017




22.5.2017


Aerinaze


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


EU/1/07/399


24.5.2017




22.5.2017


Clopidogrel BGR


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


EU/1/09/558


24.5.2017




22.5.2017


Dacogen


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


EU/1/12/792


24.5.2017




22.5.2017


Faslodex


AstraZeneca UK Limited
Charter Way, Macclesfield, Cheshire, SK10 2NA, United Kingdom


EU/1/03/269


24.5.2017




22.5.2017


Inlyta


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


EU/1/12/777


24.5.2017




22.5.2017


IntronA


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


EU/1/99/127


24.5.2017




22.5.2017


PHEBURANE


Lucane Pharma
172 rue de Charonne, 75011 Paris, France


EU/1/13/822


24.5.2017




22.5.2017


Rasilez


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


EU/1/07/405


24.5.2017




22.5.2017


Respreeza


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


EU/1/15/1006


24.5.2017




22.5.2017


Sildenafil Actavis


Actavis Group PTC ehf.
Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland


EU/1/09/595


24.5.2017




22.5.2017


Tasigna


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


EU/1/07/422


24.5.2017




22.5.2017


Temozolomide Accord


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


EU/1/10/615


24.5.2017




22.5.2017


Zeffix


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


EU/1/99/114


24.5.2017




22.5.2017


Zoledronic acid Teva


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


EU/1/12/771


24.5.2017




22.5.2017


Zoledronic acid Teva Pharma


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


EU/1/12/772


24.5.2017




24.5.2017


Aerius


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


EU/1/00/160


30.5.2017




24.5.2017


Azomyr


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


EU/1/00/157


30.5.2017




24.5.2017


Busilvex


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


EU/1/03/254


30.5.2017




24.5.2017


Cotellic


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


EU/1/15/1048


31.5.2017




24.5.2017


Desloratadine Teva


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


EU/1/11/732


30.5.2017




24.5.2017


Ecalta


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


EU/1/07/416


30.5.2017




24.5.2017


Epivir


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


EU/1/96/015


30.5.2017




24.5.2017


Fasturtec


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


EU/1/00/170


30.5.2017




24.5.2017


Ferriprox


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


EU/1/99/108


30.5.2017




24.5.2017


Harvoni


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/14/958


30.5.2017




24.5.2017


Imnovid


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


EU/1/13/850


30.5.2017




24.5.2017


Kaletra


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/01/172


30.5.2017




24.5.2017


Memantine LEK


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


EU/1/13/826


31.5.2017




24.5.2017


Mirvaso


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


EU/1/13/904


30.5.2017




24.5.2017


Neoclarityn


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


EU/1/00/161


30.5.2017




24.5.2017


NovoThirteen


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


EU/1/12/775


30.6.2017




24.5.2017


Tafinlar


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


EU/1/13/865


30.5.2017




24.5.2017


Tasigna


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


EU/1/07/422


30.5.2017




24.5.2017


Zoledronic acid Mylan


Mylan S.A.S
117 allée des Parcs, F-69800 Saint Priest, France


EU/1/12/786


30.5.2017




31.5.2017


Azopt


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


EU/1/00/129


2.6.2017




31.5.2017


Benepali


Samsung Bioepis UK Limited
3000 Hillswood Drive, Chertsey, Surrey KT16 0RS, United Kingdom


EU/1/15/1074


2.6.2017




31.5.2017


Chenodeoxycholic acid Leadiant


Leadiant GmbH
Liebherrstr. 22, 80538 München, Deutschland


EU/1/16/1110


2.6.2017




31.5.2017


Clopidogrel Apotex


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


EU/1/09/568


2.6.2017




31.5.2017


Elocta


Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm, Sverige


EU/1/15/1046


2.6.2017




31.5.2017


InductOs


Medtronic BioPharma B.V.
Earl Bakkenstraat 10, NL-6422 PJ Heerlen, Nederland


EU/1/02/226


2.6.2017




31.5.2017


Lopinavir/Ritonavir Mylan


Mylan S.A.S
117 allée des Parcs, F-69800 Saint Priest, France


EU/1/15/1067


2.6.2017




31.5.2017


Odomzo


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


EU/1/15/1030


2.6.2017




31.5.2017


Sycrest


Organon N.V.
Kloosterstraat 6, NL-5349 AB Oss, Nederland


EU/1/10/640


2.6.2017




31.5.2017


Yervoy


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


EU/1/11/698


2.6.2017










—



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




15.5.2017


Zeleris


florfenicol/meloxicam


Ceva Santé Animale
10 av. de La Ballastière, 33500 Libourne, France


EU/2/17/210


Solution for injection


QJ01BA99


17.5.2017




17.5.2017


RESPIPORC FLUpan H1N1


Porcine influenza vaccine (inactivated)


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


EU/2/17/209


Suspension for injection


QI09AA03


19.5.2017




24.5.2017


Ingelvac PCV FLEX


Porcine circovirus vaccine (inactivated)


Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein, Deutschland


EU/2/17/208


Suspension for injection


QI09AA07


30.5.2017










—



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




5.5.2017


Activyl


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


EU/2/10/118


9.5.2017




5.5.2017


Kexxtone


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


EU/2/12/145


9.5.2017




5.5.2017


Versican Plus Pi/L4R


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


EU/2/14/173


9.5.2017




15.5.2017


NEXGARD SPECTRA


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


EU/2/14/177


17.5.2017




15.5.2017


Novem


Boehringer Ingelheim Vetmedica GmbH
D-55216 Ingelheim am Rhein, Deutschland


EU/2/04/042


17.5.2017




15.5.2017


Poulvac E. coli


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


EU/2/12/140


17.5.2017




15.5.2017


Zactran


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


EU/2/08/082


17.5.2017




17.5.2017


Suprelorin


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


EU/2/07/072


19.5.2017




17.5.2017


Suvaxyn Circo + MH RTU


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


EU/2/15/190


22.5.2017




24.5.2017


Activyl Tick Plus


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


EU/2/11/137


30.5.2017




24.5.2017


Profender


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/05/054


30.5.2017




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





European Medicines Agency




30 Churchill Place




Canary Wharf




London E14 5EU




United Kingdom






(1)  OJ L 136, 30.4.2004, p. 1.