Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 29 February 2016 (Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2016-04-01
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, withdrawal from the market








C_2016116EN.01000101.xml










1.4.2016   


EN


Official Journal of the European Union


C 116/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 to 29 February 2016
(Published pursuant to Article 13 or 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2016/C 116/01)
—   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 authorization


Number of the entry in the Community Register


Pharmaceutical form


ATC code (Anatomical Therapeutic Chemical Code)


Date of notification




2.2.2016


TAGRISSO


osimertinib


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/16/1086


Film-coated tablet


L01XE35


4.2.2016




11.2.2016


Caspofungin Accord


caspofungin


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


EU/1/15/1081


Powder for concentrate for solution for infusion


J02AX04


15.2.2016




15.2.2016


Portrazza


necitumumab


Eli Lilly Nederland B.V.
Grootslag 1-5, NL-3991 RA Houten, Nederland


EU/1/15/1084


Concentrate for solution for infusion


L01XC22


18.2.2016




15.2.2016


Vaxelis


Diphtheria, tetanus, pertussis (acellular, component), hepatitis B (rDNA), poliomyelitis (inactivated) and haemophilus type b conjugate vaccine (adsorbed)


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


EU/1/15/1079


Suspension for injection


J07CA09


17.2.2016




18.2.2016


Feraccru


ferric maltol


Iron Therapeutics (UK) Ltd
Gateshead Quays, NE8 3DF, United Kingdom


EU/1/15/1075


Capsule, hard


B03AB10


22.2.2016




18.2.2016


Iblias


octocog alfa


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/15/1077


Powder and solvent for solution for injection


B02BD02


22.2.2016




18.2.2016


Kovaltry


octocog alfa


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/15/1076


Powder and solvent for solution for injection


B02BD02


22.2.2016




18.2.2016


Zurampic


lesinurad


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/15/1080


Film-coated tablet


M04AB05


22.2.2016




—   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




8.2.2016


Hepsera


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/03/251


10.2.2016




8.2.2016


Irbesartan Teva


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


EU/1/09/576


10.2.2016




8.2.2016


Iscover


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


EU/1/98/070


10.2.2016




8.2.2016


Methylthioninium chloride Proveblue


Provepharm S.A.S.
22 Rue Marc Donadille, 13013 Marseille, France


EU/1/11/682


10.2.2016




8.2.2016


Plavix


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


EU/1/98/069


10.2.2016




8.2.2016


Zoledronic acid Accord


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


EU/1/13/834


10.2.2016




11.2.2016


Sevelamer carbonate Zentiva


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


EU/1/14/952


15.2.2016




11.2.2016


Simbrinza


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


EU/1/14/933


15.2.2016




11.2.2016


Sutent


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


EU/1/06/347


15.2.2016




11.2.2016


Truvada


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/04/305


15.2.2016




11.2.2016


Vitekta


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/883


15.2.2016




11.2.2016


Xigduo


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/13/900


15.2.2016




11.2.2016


Zoledronic acid Teva


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


EU/1/12/771


15.2.2016




11.2.2016


Zostavax


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


EU/1/06/341


15.2.2016




11.2.2016


Zydelig


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/14/938


15.2.2016




15.2.2016


Latuda


Sunovion Pharmaceuticals Europe Ltd
First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom


EU/1/14/913


17.2.2016




15.2.2016


Rivastigmine Actavis


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


EU/1/11/693


17.2.2016




18.2.2016


Aldara


Meda AB
Pipers väg 2A, SE-170 73 Solna, Sverige


EU/1/98/080


22.2.2016




18.2.2016


Benlysta


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


EU/1/11/700


22.2.2016




18.2.2016


Biopoin


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


EU/1/09/565


22.2.2016




18.2.2016


Brilique


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/10/655


22.2.2016




18.2.2016


BYDUREON


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/11/696


22.2.2016




18.2.2016


Hizentra


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


EU/1/11/687


22.2.2016




18.2.2016


Lamivudine Teva Pharma B.V.


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


EU/1/09/596


22.2.2016




18.2.2016


Lojuxta


Aegerion Pharmaceuticals Limited
Lakeside House, 1 Furzeground Way, Stockley Park East, Uxbridge UB11 1BD, United Kingdom


EU/1/13/851


22.2.2016




18.2.2016


Methylthioninium chloride Proveblue


Provepharm S.A.S.
22 Rue Marc Donadille, 13013 Marseille, France


EU/1/11/682


22.2.2016




18.2.2016


Mycophenolate mofetil Teva


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


EU/1/07/439


22.2.2016




18.2.2016


Myfenax


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


EU/1/07/438


22.2.2016




18.2.2016


NULOJIX


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


EU/1/11/694


22.2.2016




18.2.2016


TOBI Podhaler


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


EU/1/10/652


22.2.2016




18.2.2016


Trajenta


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


EU/1/11/707


22.2.2016




18.2.2016


Victrelis


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


EU/1/11/704


22.2.2016




22.2.2016


Azilect


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


EU/1/04/304


24.2.2016




22.2.2016


Constella


Allergan Pharmaceuticals International Ltd
Clonshaugh Business & Technology Park Coolock Dublin D17 E400, Ireland


EU/1/12/801


24.2.2016




22.2.2016


Eporatio


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


EU/1/09/573


24.2.2016




22.2.2016


Fasturtec


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


EU/1/00/170


24.2.2016




22.2.2016


Herceptin


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


EU/1/00/145


24.2.2016




22.2.2016


Ketoconazole HRA


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


EU/1/14/965


24.2.2016




22.2.2016


Scintimun


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


EU/1/09/602


24.2.2016




22.2.2016


Tygacil


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


EU/1/06/336


24.2.2016




22.2.2016


Vizarsin


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


EU/1/09/551


24.2.2016




22.2.2016


Zoledronic acid Mylan


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


EU/1/12/786


24.2.2016




24.2.2016


Afinitor


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


EU/1/09/538


26.2.2016




24.2.2016


Brintellix


H. Lundbeck A/S
Ottiliavej 9, DK-2500 Valby, Danmark


EU/1/13/891


26.2.2016




24.2.2016


Firdapse


BioMarin Europe Ltd
10 Bloomsbury Way, London WC1A 2SL, United Kingdom


EU/1/09/601


26.2.2016




24.2.2016


Odomzo


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


EU/1/15/1030


26.2.2016




24.2.2016


Peyona


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


EU/1/09/528


26.2.2016




24.2.2016


Ravicti


Horizon Pharma Ireland Limited
Connaught House, 1st Floor, 1 Burlington Road, Dublin 4, D04 C5Y6, Ireland


EU/1/15/1062


3.3.2016




24.2.2016


Silodyx


Recordati Ireland Ltd
Raheens East, Ringaskiddy Co. Cork, Ireland


EU/1/09/607


26.2.2016




24.2.2016


Stribild


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/830


26.2.2016




24.2.2016


Vylaer Spiromax


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


EU/1/14/949


26.2.2016




24.2.2016


Xultophy


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


EU/1/14/947


26.2.2016




25.2.2016


Cerdelga


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


EU/1/14/974


1.3.2016




26.2.2016


Bridion


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


EU/1/08/466


1.3.2016




26.2.2016


Clopidogrel/Acetylsalicylic acid Zentiva (ex DuoCover)


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


EU/1/10/623


1.3.2016




26.2.2016


Jentadueto


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


EU/1/12/780


1.3.2016




26.2.2016


PREZISTA


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


EU/1/06/380


1.3.2016




26.2.2016


Urorec


Recordati Ireland Ltd
Raheens East, Ringaskiddy Co. Cork, Ireland


EU/1/09/608


1.3.2016




26.2.2016


Vibativ


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


EU/1/11/705


2.3.2016




26.2.2016


Viread


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/01/200


1.3.2016




—   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




24.2.2016


Kepivance


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


EU/1/05/314


29.2.2016




—   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




10.2.2016


Zactran


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


EU/2/08/082


12.2.2016




25.2.2016


Activyl Tick Plus


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


EU/2/11/137


29.2.2016




25.2.2016


Vectra 3D


CEVA SANTE ANIMALE
10 avenue de la Ballastière, F-33500 Libourne, France


EU/2/13/156


29.2.2016




25.2.2016


Vectra Felis


CEVA SANTE ANIMALE
10 avenue de la Ballastière, F-33500 Libourne, France


EU/2/14/165


29.2.2016




26.2.2016


Econor


Elanco Europe Ltd
Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom


EU/2/98/010


1.3.2016




26.2.2016


Trifexis


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


EU/2/13/155


1.3.2016




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.