Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2017 to 31 March 2017 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2017-04-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug, withdrawal from the market








C_2017135EN.01000101.xml










28.4.2017   


EN


Official Journal of the European Union


C 135/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 March 2017 to 31 March 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 135/01)






—



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




3.3.2017


Ledaga


chlormethine


Actelion Registration Ltd
Chiswick Tower, 13th Floor, 389 Chiswick High Road, London W4 4AL, United Kingdom


EU/1/16/1171


Gel


L01AA05


7.3.2017




20.3.2017


Rolufta


umeclidinium


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


EU/1/17/1174


Inhalation powder, pre-dispensed


R03BB07


22.3.2017




22.3.2017


AMGEVITA


adalimumab


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


EU/1/16/1164


Solution for injection


L04AB04


24.3.2017




22.3.2017


Daptomycin Hospira


daptomycin


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


EU/1/17/1175


Powder for solution for injection or infusion


J01XX09


24.3.2017




22.3.2017


SOLYMBIC


adalimumab


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


EU/1/16/1163


Solution for injection


L04AB04


24.3.2017




22.3.2017


Tadalafil Lilly


tadalafil


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


EU/1/17/1177


Film-coated tablet


G04BE08


24.3.2017




22.3.2017


Xeljanz


Tofacitinib


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


EU/1/17/1178


Film-coated tablet


L04AA29


24.3.2017




22.3.2017


Yargesa


miglustat


JensonR+ Limited
Fishleigh Court, Fishleigh Road, Barnstaple, Devon, EX31 3UD, United Kingdom


EU/1/17/1176


Capsule, hard


A16AX06


24.3.2017




29.3.2017


Jylamvo


methotrexate


Therakind Ltd
314 Regents Park Road, London N3 2JX, United Kingdom


EU/1/17/1172


Oral solution


L01BA01


31.3.2017










—



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




3.3.2017


Baraclude


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


EU/1/06/343


7.3.2017




3.3.2017


Combivir


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


EU/1/98/058


7.3.2017




3.3.2017


Deltyba


Otsuka Novel Products GmbH
Erika-Mann-Straße 21, D-80636 München, Deutschland


EU/1/13/875


7.3.2017




3.3.2017


Gardasil 9


MSD VACCINS
162 avenue Jean Jaurès, 69007 Lyon, France


EU/1/15/1007


7.3.2017




3.3.2017


Synjardy


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


EU/1/15/1003


7.3.2017




9.3.2017


Ziagen


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


EU/1/99/112


13.3.2017




17.3.2017


Fortacin


Plethora Solutions Limited
Hampden House, Monument Business Park, Chalgrove, OX44 7RW United Kingdom


EU/1/13/881


21.3.2017




17.3.2017


Tybost


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/13/872


21.3.2017




20.3.2017


Benlysta


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


EU/1/11/700


22.3.2017




20.3.2017


Entacapone Teva


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


EU/1/10/665


22.3.2017




20.3.2017


Repso


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


EU/1/11/674


22.3.2017




20.3.2017


Telmisartan Teva


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


EU/1/09/610


22.3.2017




20.3.2017


Unituxin


United Therapeutics Europe Ltd
Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom


EU/1/15/1022


22.3.2017




20.3.2017


Xiapex


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


EU/1/11/671


22.3.2017




22.3.2017


BeneFIX


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


EU/1/97/047


23.3.2017




22.3.2017


Betaferon


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/95/003


24.3.2017




22.3.2017


Briviact


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


EU/1/15/1073


24.3.2017




22.3.2017


Cosentyx


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


EU/1/14/980


24.3.2017




22.3.2017


Fluenz Tetra


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/13/887


24.3.2017




22.3.2017


Ilaris


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


EU/1/09/564


24.3.2017




22.3.2017


Jentadueto


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


EU/1/12/780


24.3.2017




22.3.2017


Latuda


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


EU/1/14/913


24.3.2017




22.3.2017


Pixuvri


CTI Life Sciences Ltd
Highland House, Basingstoke Road, Spencers Wood, Reading, Berkshire RG7 1NT, United Kingdom


EU/1/12/764


24.3.2017




22.3.2017


TAGRISSO


AstraZeneca AB
Gärtunavägen, SE-151 85 Södertälje, Sverige


EU/1/16/1086


24.3.2017




22.3.2017


Zyclara


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


EU/1/12/783


24.3.2017




24.3.2017


Bosulif


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


EU/1/13/818


28.3.2017




24.3.2017


Caelyx


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


EU/1/96/011


28.3.2017




24.3.2017


Genvoya


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/15/1061


28.3.2017




24.3.2017


Humira


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/03/256


28.3.2017




24.3.2017


JEVTANA


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


EU/1/11/676


28.3.2017




24.3.2017


Nemdatine


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


EU/1/13/824


28.3.2017




24.3.2017


Nevirapine Teva


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


EU/1/09/598


28.3.2017




24.3.2017


NULOJIX


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


EU/1/11/694


28.3.2017




24.3.2017


Odefsey


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/16/1112


28.3.2017




24.3.2017


Opdivo


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


EU/1/15/1014


28.3.2017




24.3.2017


Pandemic influenza vaccine H5N1 BAXTER


Nanotherapeutics UK Limited
10 Chiswell Street, London, EC1Y 4UQ, United Kingdom


EU/1/09/571


28.3.2017




24.3.2017


Truvada


Gilead Sciences International Ltd
Cambridge, CB21 6GT, United Kingdom


EU/1/04/305


28.3.2017




24.3.2017


Vimpat


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


EU/1/08/470


28.3.2017




27.3.2017


Mekinist


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


EU/1/14/931


29.3.2017




29.3.2017


Clopidogrel/Acetylsalicylic acid Zentiva


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


EU/1/10/623


31.3.2017




29.3.2017


Descovy


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/16/1099


31.3.2017




29.3.2017


EVARREST


Omrix Biopharmaceuticals N.V.
Leonardo Da Vincilaan 15, B-1831 Diegem, België


EU/1/13/868


31.3.2017




29.3.2017


Iressa


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/09/526


31.3.2017




29.3.2017


Levitra


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/03/248


31.3.2017




29.3.2017


Plavix


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


EU/1/98/069


31.3.2017




29.3.2017


Tafinlar


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


EU/1/13/865


31.3.2017










—



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




20.3.2017


Unituxin


United Therapeutics Europe Ltd
Unither House, Curfew Bell Road, Chertsey, Surrey KT16 9FG, United Kingdom


EU/1/15/1022


22.3.2017










—



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




6.3.2017


Rabigen SAG2


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


EU/2/00/021


8.3.2017




13.3.2017


Nobivac L4


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


EU/2/12/143


15.3.2017




29.3.2017


Dexdomitor


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/2/02/033


31.3.2017




29.3.2017


Porcilis ColiClos


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


EU/2/12/141


31.3.2017




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.