Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2016 to 30 June 2016 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-07-29
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug, withdrawal from the market








C_2016277EN.01000101.xml










29.7.2016   


EN


Official Journal of the European Union


C 277/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2016 to 30 June 2016
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 277/01)
—   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




21.6.2016


Odefsey


emtricitabine/rilpivirine/tenofovir alafenamide


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/16/1112


Film-coated tablet


J05AR19


23.6.2016




24.6.2016


Ongentys


opicapone


Bial — Portela & Ca, SA
À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal


EU/1/15/1066


Capsule, hard


Pending


28.6.2016




24.6.2016


Zavicefta


ceftazidime/avibactam


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/16/1109


Powder for concentrate for solution for infusion


J01DD52


28.6.2016




29.6.2016


Enzepi


pancreas powder


APTALIS PHARMA SAS
5/6 Place de l’Iris — La Défense 5
92400 Courbevoie France


EU/1/16/1113


Capsule, hard, gastro-resistant


A09AA02


1.7.2016




—   Issuing of a marketing authorization (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 authorization


Number of the entry in the Community Register


Date of notification




24.6.2016


Dropcys


Lucane Pharma
172 rue de Charonne, 75011 Paris, France


 


28.6.2016




—   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




1.6.2016


Cotellic


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


EU/1/15/1048


3.6.2016




1.6.2016


HyQvia


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


EU/1/13/840


6.6.2016




1.6.2016


Revlimid


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


EU/1/07/391


3.6.2016




1.6.2016


Zinforo


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/12/785


3.6.2016




2.6.2016


Adrovance


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


EU/1/06/364


6.6.2016




2.6.2016


Altargo


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


EU/1/07/390


6.6.2016




2.6.2016


Avastin


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


EU/1/04/300


6.6.2016




2.6.2016


Capecitabine Accord


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


EU/1/12/762


6.6.2016




2.6.2016


Clopidogrel BGR


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


EU/1/09/558


6.6.2016




2.6.2016


Clopidogrel Krka


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


EU/1/09/556


7.6.2016




2.6.2016


Clopidogrel ratiopharm GmbH


Archie Samuel s.r.o.
Slunná 16, CZ-61700 Brno, Česká republika


EU/1/09/541


6.6.2016




2.6.2016


Imatinib Actavis


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


EU/1/13/825


6.6.2016




2.6.2016


Kineret


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


EU/1/02/203


7.6.2016




2.6.2016


Kiovig


Baxter AG
Industriestrasse 67, A-1221 Wien, Österreich


EU/1/05/329


6.6.2016




2.6.2016


Lonquex


UAB ‘Sicor Biotech’
Molėtų pl. 5, LT-08409 Vilnius, Lietuva


EU/1/13/856


6.6.2016




2.6.2016


Neuraceq


Piramal Imaging Limited
Langstone Technology Park, Langstone Road, Havant, Hampshire, PO9 1SA, United Kingdom


EU/1/13/906


6.6.2016




2.6.2016


Tasigna


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


EU/1/07/422


6.6.2016




2.6.2016


Temozolomide Accord


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


EU/1/10/615


6.6.2016




2.6.2016


Vimpat


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


EU/1/08/470


6.6.2016




9.6.2016


Cubicin


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


EU/1/05/328


13.6.2016




9.6.2016


Telmisartan Teva Pharma


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


EU/1/11/719


13.6.2016




9.6.2016


VPRIV


Shire Pharmaceuticals Ireland Limited
5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/10/646


13.6.2016




9.6.2016


Zyllt


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


EU/1/09/553


13.6.2016




13.6.2016


Gazyvaro


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


EU/1/14/937


15.6.2016




16.6.2016


Advagraf


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


EU/1/07/387


20.6.2016




16.6.2016


Avonex


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


EU/1/97/033


20.6.2016




16.6.2016


Protopic


Leo Pharma A/S
Industriparken 55, DK-2750 Ballerup, Danmark


EU/1/02/201


20.6.2016




16.6.2016


Tesavel


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


EU/1/07/435


20.6.2016




16.6.2016


Xelevia


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


EU/1/07/382


20.6.2016




21.6.2016


Eurartesim


Sigma-Tau Industrie Farmaceutiche Riunite S.p.A
Viale Shakespeare 47, 00144 Roma, Italia


EU/1/11/716


23.6.2016




21.6.2016


Irbesartan Zentiva


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


EU/1/06/376


23.6.2016




21.6.2016


Karvea


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


EU/1/97/049


23.6.2016




21.6.2016


Lemtrada


Genzyme Therapeutics Ltd
4620 Kingsgate, Cascade Way, Oxford Business Park South, Oxford OX4 2SU, United Kingdom


EU/1/13/869


23.6.2016




21.6.2016


Modigraf


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


EU/1/09/523


23.6.2016




21.6.2016


Reyataz


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


EU/1/03/267


23.6.2016




21.6.2016


Zometa


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


EU/1/01/176


23.6.2016




24.6.2016


ADCETRIS


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


EU/1/12/794


28.6.2016




24.6.2016


Advate


Baxter AG
Industriestrasse 67, A-1221 Wien, Österreich


EU/1/03/271


28.6.2016




24.6.2016


Aprovel


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


EU/1/97/046


28.6.2016




24.6.2016


Cubicin


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


EU/1/05/328


28.6.2016




24.6.2016


Daklinza


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


EU/1/14/939


28.6.2016




24.6.2016


Emtriva


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/03/261


28.6.2016




24.6.2016


Grepid


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


EU/1/09/535


28.6.2016




24.6.2016


Humira


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/03/256


28.6.2016




24.6.2016


Imnovid


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


EU/1/13/850


28.6.2016




24.6.2016


Januvia


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


EU/1/07/383


28.6.2016




24.6.2016


Rasilez


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


EU/1/07/405


28.6.2016




24.6.2016


Rasilez HCT


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


EU/1/08/491


28.6.2016




24.6.2016


Relvar Ellipta


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


EU/1/13/886


28.6.2016




24.6.2016


Revinty Ellipta


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


EU/1/14/929


28.6.2016




24.6.2016


Simponi


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


EU/1/09/546


28.6.2016




24.6.2016


Tolura


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


EU/1/10/632


28.6.2016




24.6.2016


Tysabri


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


EU/1/06/346


28.6.2016




24.6.2016


Zoledronic acid Hospira


Hospira UK Limited
Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom


EU/1/12/800


28.6.2016




29.6.2016


Champix


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


EU/1/06/360


1.7.2016




29.6.2016


Incivo


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


EU/1/11/720


1.7.2016




29.6.2016


Kivexa


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


EU/1/04/298


1.7.2016




29.6.2016


Kyprolis


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


EU/1/15/1060


1.7.2016




29.6.2016


Matever


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


EU/1/11/711


1.7.2016




29.6.2016


Memantine Mylan


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


EU/1/13/827


8.7.2016




29.6.2016


Mycamine


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


EU/1/08/448


1.7.2016




29.6.2016


PegIntron


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


EU/1/00/131


1.7.2016




29.6.2016


Revestive


NPS Pharma Holdings Limited
5 Riverwalk, Citywest Business Campus, Dublin 24, Ireland


EU/1/12/787


1.7.2016




29.6.2016


Tyverb


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


EU/1/07/440


1.7.2016




29.6.2016


Vidaza


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


EU/1/08/488


1.7.2016




29.6.2016


ViraferonPeg


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


EU/1/00/132


4.7.2016




29.6.2016


Yondelis


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


EU/1/07/417


1.7.2016




29.6.2016


Zoledronic acid medac


medac Gesellschaft für klinische Spezialpräparate mbH
Theaterstr. 6, D-22880 Wedel, Deutschland


EU/1/12/779


1.7.2016




30.6.2016


Ceplene


Meda AB
Box 906, SE-170 09 Solna, Sverige


EU/1/08/477


5.7.2016




30.6.2016


Dacogen


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


EU/1/12/792


4.7.2016




30.6.2016


Efficib


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


EU/1/08/457


4.7.2016




30.6.2016


Eylea


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/12/797


4.7.2016




30.6.2016


Filgrastim Hexal


Hexal AG
Industriestrasse 25, D-83607 Holzkirchen, Deutschland


EU/1/08/496


4.7.2016




30.6.2016


Hycamtin


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


EU/1/96/027


4.7.2016




30.6.2016


Janumet


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


EU/1/08/455


4.7.2016




30.6.2016


OLYSIO


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


EU/1/14/924


4.7.2016




30.6.2016


Ristaben


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


EU/1/10/621


4.7.2016




30.6.2016


Toujeo


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


EU/1/00/133


4.7.2016




30.6.2016


Velmetia


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


EU/1/08/456


4.7.2016




30.6.2016


Yentreve


Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland


EU/1/04/280


4.7.2016




30.6.2016


Zarzio


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/08/495


4.7.2016




—   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




1.6.2016


Clopidogrel/Acetylsalicylic acid Teva


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


EU/1/14/942


3.6.2016




21.6.2016


Capecitabine SUN


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


EU/1/13/831


23.6.2016




30.6.2016


Krystexxa


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


EU/1/12/810


4.7.2016




30.6.2016


Opgenra


Olympus Biotech International Limited
40 Upper Mount Street, Dublin 2, Ireland


EU/1/08/489


4.7.2016




—   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




21.6.2016


Sevocalm


sevoflurane


Chanelle Pharmaceuticals Manufacturing Limited
Loughrea, Co. Galway, Ireland


EU/2/16/196


Inhalation vapour, liquid


Pending


24.6.2016




—   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




3.6.2016


Nobivac L4


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


EU/2/12/143


7.6.2016




21.6.2016


Emdocam


Emdoka bvba
J. Lijsenstraat 16, B-2321 Hoogstraten, België


EU/2/11/128


23.6.2016




21.6.2016


Metacam


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


EU/2/97/004


23.6.2016




22.6.2016


Nobilis Influenza H5N2


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


EU/2/06/061


24.6.2016




24.6.2016


Loxicom


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


EU/2/08/090


29.6.2016




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.