Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2015 to 30 November 2015 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2015-12-30
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, withdrawal from the market








C_2015439EN.01000101.xml










30.12.2015   


EN


Official Journal of the European Union


C 439/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 November 2015 to 30 November 2015
(Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council (1))
(2015/C 439/01)
—   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




9.11.2015


Edistride


dapagliflozin


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/15/1052


Film-coated tablet


A10BX09


12.11.2015




11.11.2015


Obizur


susoctocog alfa


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


EU/1/15/1035


Powder and solvent for solution for injection


B02BD14


13.11.2015




16.11.2015


Aripiprazole Accord


aripiprazole


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


EU/1/15/1045


Tablet


N05AX12


19.11.2015




16.11.2015


Ebymect


dapagliflozin/metfomin


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/15/1051


Film-coated tablet


A10BD15


18.11.2015




16.11.2015


Votubia


Everolimus


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


EU/1/11/710


Tablet


L01XE10


23.11.2015




19.11.2015


Cinacalcet Mylan


cinacalcet


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


EU/1/15/1054


Film-coated tablet


H05BX01


23.11.2015




19.11.2015


Elocta


efmoroctocog alfa


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


EU/1/15/1046


Powder and solvent for solution for injection


Pending


23.11.2015




19.11.2015


Entresto


sacubitril/valsartan


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


EU/1/15/1058


Film-coated tablet


C09DX04


23.11.2015




19.11.2015


Genvoya


elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide


Gilead Sciences International Limited
Cambridge CB21 6GT, United Kingdom


EU/1/15/1061


Film-coated tablet


J05AR18


23.11.2015




19.11.2015


IONSYS


fentanyl


Incline Therapeutics Europe Ltd
21 St. Thomas Street, Bristol, BS1 6JS, United Kingdom


EU/1/15/1050


Transdermal system


N02AB03


23.11.2015




19.11.2015


Kyprolis


carfilzomib


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


EU/1/15/1060


Powder for solution for infusion


L01XX45


23.11.2015




19.11.2015


Numient


levodopa/carbidopa


Impax Laboratories (Netherlands) BV
WTC Schiphol Airport Schiphol Boulevard 231, 1118 BH Amsterdam Schiphol, Nederland


EU/1/15/1044


Modified-release capsule, hard


N04BA02


23.11.2015




19.11.2015


Orkambi


Lumacaftor/Ivacaftor


Vertex Pharmaceuticals (Europe) Limited
2 Kingdom Street, London W2 6BD, United Kingdom


EU/1/15/1059


Film-coated tablet


R07AX30


24.11.2015




20.11.2015


Cotellic


cobimetinib


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


EU/1/15/1048


Film-coated tablet


Pending


24.11.2015




20.11.2015


Kolbam


cholic acid


Retrophin Europe Limited
25/28 North Wall Quay, Dublin 1, Ireland


EU/1/13/895


Capsule, hard


A05AA03


24.11.2015




20.11.2015


Pemetrexed Hospira


pemetrexed


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


EU/1/15/1057


Powder for concentrate for solution for infusion


L01BA04


24.11.2015




20.11.2015


Praxbind


idarucizumab


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


EU/1/15/1056


Powder and solvent for solution for injection/infusion


V03AB


24.11.2015




23.11.2015


Blincyto


blinatumomab


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


EU/1/15/1047


Powder for concentrate for solution for infusion


L01XC19


25.11.2015




27.11.2015


Pemetrexed medac


Pemetrexed


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


EU/1/15/1038


Powder for concentrate for solution for infusion


L01BA04


1.12.2015




27.11.2015


Ravicti


Glycerol phenylbutyrate


Horizon Therapeutics Limited
90 Long Acre, Covent Garden, London WC2E 9RZ, United Kingdom


EU/1/15/1062


Oral liquid


A16AX09


1.12.2015




—   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




3.11.2015


Dexdor


Orion Corporation
Orionintie 1, FI-02200 Espoo, Suomi


EU/1/11/718


5.11.2015




3.11.2015


Ventavis


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/03/255


5.11.2015




6.11.2015


Relvar Ellipta


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


EU/1/13/886


10.11.2015




6.11.2015


Vedrop


Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France


EU/1/09/533


10.11.2015




10.11.2015


InductOs


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


EU/1/02/226


12.11.2015




11.11.2015


Aranesp


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


EU/1/01/185


13.11.2015




11.11.2015


Comtan


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


EU/1/98/081


13.11.2015




11.11.2015


Nplate


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


EU/1/08/497


13.11.2015




11.11.2015


Revestive


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


EU/1/12/787


13.11.2015




11.11.2015


Ristfor


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


EU/1/10/620


13.11.2015




16.11.2015


Imatinib Accord


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


EU/1/13/845


18.11.2015




16.11.2015


Kalydeco


Vertex Pharmaceuticals (Europe) Limited
2 Kingdom Street, London W2 6BD, United Kingdom


EU/1/12/782


19.11.2015




16.11.2015


Suboxone


Indivior UK Limited
103-105 Bath Road, Slough, Berkshire, SL1 3UH, United Kingdom


EU/1/06/359


18.11.2015




19.11.2015


ADCETRIS


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


EU/1/12/794


23.11.2015




19.11.2015


Alimta


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


EU/1/04/290


23.11.2015




19.11.2015


Carbaglu


Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France


EU/1/02/246


23.11.2015




19.11.2015


Colobreathe


Forest Laboratories UK Ltd
Whiddon Valley Barnstaple, North Devon, EX32 8NS, United Kingdom


EU/1/11/747


23.11.2015




19.11.2015


Cosentyx


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


EU/1/14/980


23.11.2015




19.11.2015


Cubicin


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


EU/1/05/328


23.11.2015




19.11.2015


Cystadane


Orphan Europe S.A.R.L.
Immeuble Le Wilson, 70 avenue du Général de Gaulle, F-92 800 Puteaux, France


EU/1/06/379


23.11.2015




19.11.2015


Entacapone Teva


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


EU/1/10/665


23.11.2015




19.11.2015


Exelon


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


EU/1/98/066


23.11.2015




19.11.2015


GILENYA


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


EU/1/11/677


23.11.2015




19.11.2015


HALAVEN


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


EU/1/11/678


23.11.2015




19.11.2015


Humira


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/03/256


23.11.2015




19.11.2015


Ifirmacombi


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


EU/1/11/673


23.11.2015




19.11.2015


Imnovid


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


EU/1/13/850


23.11.2015




19.11.2015


Isentress


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


EU/1/07/436


23.11.2015




19.11.2015


JEVTANA


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


EU/1/11/676


23.11.2015




19.11.2015


Krystexxa


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


EU/1/12/810


23.11.2015




19.11.2015


Lamivudine/Zidovudine Teva


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


EU/1/10/663


23.11.2015




19.11.2015


Macugen


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


EU/1/05/325


24.11.2015




19.11.2015


Mirvaso


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


EU/1/13/904


23.11.2015




19.11.2015


NovoNorm


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


EU/1/98/076


23.11.2015




19.11.2015


Optimark


Mallinckrodt Deutschland GmbH
Josef-Dietzgen-Strasse 1, D-53773 Hennef, Deutschland


EU/1/07/398


23.11.2015




19.11.2015


Prandin


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


EU/1/00/162


23.11.2015




19.11.2015


Prometax


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


EU/1/98/092


23.11.2015




19.11.2015


Ranexa


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


EU/1/08/462


23.11.2015




19.11.2015


Simulect


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


EU/1/98/084


23.11.2015




19.11.2015


Teysuno


Nordic Group B.V.
Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland


EU/1/11/669


23.11.2015




19.11.2015


Thalidomide Celgene


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


EU/1/08/443


23.11.2015




19.11.2015


Thymanax


Servier (Ireland) Industries Limited
Gorey Road, Arklow, Co. Wicklow, Ireland


EU/1/08/498


23.11.2015




19.11.2015


Valdoxan


Les Laboratoires Servier
50 rue Carnot, F-92284 Suresnes Cedex, France


EU/1/08/499


23.11.2015




19.11.2015


Vfend


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


EU/1/02/212


23.11.2015




19.11.2015


XALKORI


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


EU/1/12/793


23.11.2015




19.11.2015


Xenical


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


EU/1/98/071


23.11.2015




20.11.2015


EDURANT


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


EU/1/11/736


24.11.2015




20.11.2015


Volibris


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


EU/1/08/451


25.11.2015




23.11.2015


alli


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


EU/1/07/401


25.11.2015




23.11.2015


Bosulif


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


EU/1/13/818


25.11.2015




23.11.2015


GILENYA


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


EU/1/11/677


25.11.2015




23.11.2015


XALKORI


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


EU/1/12/793


25.11.2015




23.11.2015


Xiapex


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


EU/1/11/671


25.11.2015




27.11.2015


CellCept


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


EU/1/96/005


1.12.2015




27.11.2015


Iclusig


ARIAD Pharma Ltd
Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom


EU/1/13/839


1.12.2015




27.11.2015


Pandemic influenza vaccine H5N1 BAXTER


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


EU/1/09/571


1.12.2015




27.11.2015


Quinsair


Raptor Pharmaceuticals Europe BV
Naritaweg 165, NL-1043 BW Amsterdam, Nederland


EU/1/14/973


1.12.2015




27.11.2015


Rapamune


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


EU/1/01/171


2.12.2015




27.11.2015


Revinty Ellipta


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


EU/1/14/929


1.12.2015




27.11.2015


Rivastigmine HEXAL


Hexal AG
Industriestrasse 25, D-83607 Holzkirchen, Deutschland


EU/1/09/589


30.11.2015




27.11.2015


Rivastigmine Sandoz


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/09/599


2.12.2015




27.11.2015


Xtandi


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


EU/1/13/846


1.12.2015




30.11.2015


Celvapan


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


EU/1/08/506


2.12.2015




30.11.2015


Rivastigmine 1 A Pharma


1 A Pharma GmbH
Keltenring 1 + 3, D-82041 Oberhaching, Deutschland


EU/1/09/585


2.12.2015




30.11.2015


Vepacel


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


EU/1/12/752


2.12.2015




—   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




30.11.2015


Nivolumab BMS


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


EU/1/15/1026


2.12.2015




—   Suspension of a marketing authorisation (Article 20 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




20.11.2015


InductOs


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


EU/1/02/226


24.11.2015




—   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




6.11.2015


Simparica


sarolaner


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


EU/2/15/191


Chewable tablet


QP53BX06


10.11.2015




6.11.2015


Suvaxyn Circo + MH RTU


Porcine circovirus and porcine enzootic pneumonia vaccine (inactivated)


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


EU/2/15/190


Emulsion for injection


QI09AL


10.11.2015




6.11.2015


Zycortal


desoxycortone


Dechra Limited
Snaygill Industrial Estate, Keighley Road, Skipton, North Yorkshire BD23 2RW, United Kingdom


EU/2/15/189


Suspension for injection


QH02AA03


10.11.2015




—   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




6.11.2015


Hiprabovis IBR Marker Live


Laboratorios Hipra, S.A.
Avda. La Selva, 135, E-17170 Amer (Girona), España


EU/2/10/114


10.11.2015




9.11.2015


Nobivac Bb


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


EU/2/02/034


11.11.2015




19.11.2015


Zolvix


Novartis Healthcare A/S
Edvard Thomsens Vej 14, DK-2300 København S, Danmark


EU/2/09/101


23.11.2015




20.11.2015


Leucofeligen FeLV/RCP


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


EU/2/09/097


24.11.2015




27.11.2015


Leucogen


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


EU/2/09/096


1.12.2015




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





The European Medicines Agency




7, Westferry Circus, Canary Wharf




UK — LONDON E14 4H






(1)  OJ L 136, 30.4.2004, p. 1.