Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2017 to 31 January 2017 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2017-02-24
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary medicine, withdrawal from the market








C_2017061EN.01000101.xml










24.2.2017   


EN


Official Journal of the European Union


C 61/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 January 2017 to 31 January 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 061/01)






—



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




4.1.2017


AFSTYLA


lonoctocog alfa


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


EU/1/16/1158


Powder and solvent for solution for injection


B02BD02


6.1.2017




4.1.2017


Darunavir Mylan


darunavir


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


EU/1/16/1140


Film-coated tablet


J05AE10


6.1.2017




4.1.2017


Lusduna


insulin glargine


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


EU/1/16/1162


Solution for injection


A10AE04


6.1.2017




4.1.2017


Terrosa


teriparatide


Gedeon Richter Plc.
Gyömrői út 19-21., H-1103 Budapest, Magyarország


EU/1/16/1159


Solution for injection


H05AA02


6.1.2017




9.1.2017


Fiasp


insulin aspart


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


EU/1/16/1160


Solution for injection


A10AB05


11.1.2017




9.1.2017


Tadalafil Generics


tadalafil


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


EU/1/16/1153


Film-coated tablet


G04BE08


11.1.2017




9.1.2017


Vemlidy


tenofovir alafenamide


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


EU/1/16/1154


Film-coated tablet


J05AF13


11.1.2017




11.1.2017


Movymia


teriparatide


STADA Arzneimittel AG
Stadastrasse 2-18, D-61118 Bad Vilbel, Deutschland


EU/1/16/1161


Solution for injection


H05AA02


13.1.2017




11.1.2017


Suliqua


insulin glargine/lixisenatide


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


EU/1/16/1157


Solution for injection


A10AE54


13.1.2017




18.1.2017


ZINPLAVA


bezlotoxumab


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


EU/1/16/1156


Concentrate for solution for infusion


J06BB21


20.1.2017




19.1.2017


Cystadrops


mercaptamine


Orphan Europe SARL
Immeuble ‘Le Wilson’, 70, Avenue du Général de Gaulle, 92800 Puteaux, France


EU/1/15/1049


Eye drops, solution


S01XA21


23.1.2017










—



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




4.1.2017


Emadine


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


EU/1/98/095


6.1.2017




4.1.2017


Imatinib Accord


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


EU/1/13/845


6.1.2017




4.1.2017


Incruse


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


EU/1/14/922


6.1.2017




4.1.2017


Kolbam


Retrophin Europe Limited
Palmerstown House, Fenian Street, Dublin 2, Ireland


EU/1/13/895


6.1.2017




4.1.2017


Vepacel


Nanotherapeutics Bohumil, s.r.o.
Bohumil 138, 28163 Jevany, Česká republika


EU/1/12/752


6.1.2017




4.1.2017


Zonegran


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


EU/1/04/307


6.1.2017




9.1.2017


Capecitabine Accord


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


EU/1/12/762


11.1.2017




9.1.2017


Capecitabine Teva


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


EU/1/12/761


11.1.2017




9.1.2017


DaTSCAN


GE Healthcare Limited
Little Chalfont, Bucks HP7 9NA, United Kingdom


EU/1/00/135


11.1.2017




9.1.2017


Foclivia


Novartis Vaccines Influenza S.r.l.
Via Fiorentina, 1, 53100 Siena, Italia


EU/1/09/577


11.1.2017




9.1.2017


Naglazyme


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


EU/1/05/324


13.1.2017




9.1.2017


Ofev


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


EU/1/14/979


11.1.2017




9.1.2017


Relistor


PharmaSwiss Česká republika s.r.o.
Jankovcova 1569/2c 17000 Praha 7 Česká republika


EU/1/08/463


11.1.2017




9.1.2017


Riluzole Zentiva


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


EU/1/12/768


11.1.2017




9.1.2017


SANCUSO


Kyowa Kirin Limited
Galabank Business Park, Galashiels, TD1 1QH, United Kingdom


EU/1/12/766


11.1.2017




9.1.2017


Translarna


PTC Therapeutics International Limited
77 Sir John Rogerson’s Quay, Dublin 2, Ireland


EU/1/13/902


11.1.2017




9.1.2017


Viagra


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


EU/1/98/077


11.1.2017




9.1.2017


Viramune


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


EU/1/97/055


11.1.2017




9.1.2017


Xultophy


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


EU/1/14/947


11.1.2017




11.1.2017


Adenuric


Menarini International Operations Luxembourg S.A.
1 avenue de la Gare, L-1611 Luxembourg, Grand-Duché de Luxembourg


EU/1/08/447


13.1.2017




11.1.2017


Brintellix


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


EU/1/13/891


13.1.2017




11.1.2017


Bronchitol


Pharmaxis Pharmaceuticals Limited
25 Moorgate, London, EC2R 6AY, United Kingdom.


EU/1/12/760


13.1.2017




11.1.2017


Cometriq


Ipsen Pharma
65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France


EU/1/13/890


13.1.2017




11.1.2017


Defitelio


Gentium S.r.l
Piazza XX Settembre, 2, I-22079 Villa Guardia (CO), Italia


EU/1/13/878


16.1.2017




11.1.2017


Entresto


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


EU/1/15/1058


13.1.2017




11.1.2017


Herceptin


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


EU/1/00/145


13.1.2017




11.1.2017


Imatinib Accord


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


EU/1/13/845


13.1.2017




11.1.2017


Inovelon


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


EU/1/06/378


13.1.2017




11.1.2017


Invanz


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


EU/1/02/216


13.1.2017




11.1.2017


Ivemend


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


EU/1/07/437


13.1.2017




11.1.2017


Kuvan


BioMarin International Limited
Shanbally, Ringaskiddy, County Cork, Ireland


EU/1/08/481


13.1.2017




11.1.2017


Pregabalin Mylan


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


EU/1/15/997


13.1.2017




11.1.2017


Pregabalin Mylan Pharma


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


EU/1/15/998


13.1.2017




11.1.2017


Ruconest


Pharming Group N.V.
Darwinweg 24, NL-2333 CR Leiden, Nederland


EU/1/10/641


13.1.2017




11.1.2017


Vimizim


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


EU/1/14/914


13.1.2017




11.1.2017


Xadago


Zambon S.p.A.
Via Lillo del Duca 10, 20 091 Bresso (MI), Italia


EU/1/14/984


13.1.2017




19.1.2017


Jardiance


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


EU/1/14/930


23.1.2017




23.1.2017


Lymphoseek


Norgine B.V.
Hogehilweg 7, 1101CA Amsterdam, Nederland


EU/1/14/955


25.1.2017




23.1.2017


Remsima


Celltrion Healthcare Hungary Kft.
Árpád Fejedelem útja 26-28, H-1023 Budapest, Magyarország


EU/1/13/853


25.1.2017




26.1.2017


Cinryze


Shire Services BVBA
rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België


EU/1/11/688


30.1.2017




26.1.2017


Iclusig


Incyte Biosciences UK Ltd
Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom


EU/1/13/839


30.1.2017




26.1.2017


NovoSeven


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


EU/1/96/006


30.1.2017




26.1.2017


Orfadin


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


EU/1/04/303


30.1.2017




26.1.2017


Picato


LEO Laboratories Ltd.
285 Cashel Road, Crumlin, Dublin 12, Ireland


EU/1/12/796


30.1.2017




26.1.2017


Rezolsta


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


EU/1/14/967


30.1.2017




26.1.2017


Voriconazole Hikma


Hikma Farmacêutica (Portugal), S.A.
Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal


EU/1/15/1004


30.1.2017




27.1.2017


Ameluz


Biofrontera Bioscience GmbH
Hemmelrather Weg 201, D-51377 Leverkusen, Deutschland


EU/1/11/740


31.1.2017




27.1.2017


Benepali


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


EU/1/15/1074


31.1.2017




27.1.2017


Docetaxel Accord


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


EU/1/12/769


31.1.2017




27.1.2017


Jentadueto


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


EU/1/12/780


31.1.2017




27.1.2017


KEYTRUDA


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


EU/1/15/1024


31.1.2017




27.1.2017


Opdivo


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


EU/1/15/1014


31.1.2017




27.1.2017


Stivarga


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/13/858


31.1.2017




27.1.2017


Trajenta


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


EU/1/11/707


31.1.2017




27.1.2017


Vaxelis


MCM Vaccine B.V.
Robert Boyleweg 4, 2333 CG Leiden, Nederland


EU/1/15/1079


31.1.2017




27.1.2017


Votubia


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


EU/1/11/710


31.1.2017




27.1.2017


Xydalba


Allergan Pharmaceuticals International Limited
Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland


EU/1/14/986


31.1.2017










—



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




9.1.2017


Vylaer Spiromax


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


EU/1/14/949


11.1.2017




18.1.2017


Clopidogrel Acino


Acino AG
Am Windfeld 35, 83714 D-Miesbach, Deutschland


EU/1/09/532


20.1.2017










—



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




9.1.2017


Coliprotec F4/F18


Porcine post-weaning diarrhoea vaccine (live)


Prevtec Microbia GmbH
Geyerspergerstr 27, 80689 München, Deutschland


EU/2/16/202


Lyophilisate for oral suspension


QI09AE03


11.1.2017










—



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




9.1.2017


Novaquin


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


EU/2/15/186


11.1.2017




18.1.2017


Nobilis IB 4-91


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


EU/2/98/006


20.1.2017




18.1.2017


Simparica


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


EU/2/15/191


20.1.2017




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.