Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2017 to 30 June 2017 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Date: 2017-07-28
Institutions: European Commission
Subjects: drug surveillance, market approval, marketing standard, medicinal product, veterinary drug, withdrawal from the market








C_2017245EN.01000101.xml










28.7.2017   


EN


Official Journal of the European Union


C 245/1





Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 June 2017 to 30 June 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 245/01)






—



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




2.6.2017


Elmiron


pentosan polysulfate sodium


bene-Arzneimittel GmbH
Herterichstr. 1-3, 81479 München, Deutschland


EU/1/17/1189


Capsule, hard


G04BX15


7.6.2017




2.6.2017


Refixia


nonacog beta pegol


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


EU/1/17/1193


Powder and solvent for solution for injection


B02BD04


7.6.2017




15.6.2017


Febuxostat Mylan


febuxostat


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


EU/1/17/1194


Film-coated tablet


M04AA03


19.6.2017




15.6.2017


Rixathon


rituximab


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/17/1185


Concentrate for solution for infusion


L01XC02


19.6.2017




15.6.2017


Riximyo


rituximab


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/17/1184


Concentrate for solution for infusion


L01XC02


19.6.2017




23.6.2017


Erelzi


etanercept


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/17/1195


Solution for injection


L04AB01


27.6.2017




23.6.2017


Kevzara


sarilumab


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


EU/1/17/1196


Solution for injection


L04AC14


27.6.2017




23.6.2017


Skilarence


dimethyl fumarate


Almirall, S.A.
Ronda General Mitre, 151, E-08022 Barcelona, España


EU/1/17/1201


Gastro-resistant tablet


Pending


27.6.2017




23.6.2017


Ucedane


carglumic acid


Lucane Pharma
172 rue de Charonne, 75011 Paris, France


EU/1/17/1202


Dispersible tablet


A16AA05


27.6.2017




29.6.2017


Besponsa


inotuzumab ozogamicin


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


EU/1/17/1200


Powder for concentrate for solution for infusion


L01XC26


3.7.2017










—



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




2.6.2017


Avastin


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


EU/1/04/300


7.6.2017




2.6.2017


Caspofungin Accord


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


EU/1/15/1081


7.6.2017




2.6.2017


Cerezyme


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


EU/1/97/053


7.6.2017




2.6.2017


Emtricitabine/Tenofovir disoproxil Mylan


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


EU/1/16/1133


7.6.2017




2.6.2017


INCRELEX


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


EU/1/07/402


7.6.2017




2.6.2017


Norvir


AbbVie Ltd
Maidenhead, SL6 4UB, United Kingdom


EU/1/96/016


7.6.2017




2.6.2017


Nplate


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


EU/1/08/497


7.6.2017




2.6.2017


Opdivo


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


EU/1/15/1014


7.6.2017




2.6.2017


PecFent


Archimedes Development Ltd
Albert Einstein Centre, Nottingham Science and Technology Park, University Boulevard NG7 2 TN Nottingham, United Kingdom


EU/1/10/644


7.6.2017




2.6.2017


Pregabalin Mylan


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


EU/1/15/997


8.6.2017




2.6.2017


Pregabalin Mylan Pharma


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


EU/1/15/998


8.6.2017




2.6.2017


Somavert


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


EU/1/02/240


7.6.2017




8.6.2017


ellaOne


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


EU/1/09/522


12.6.2017




12.6.2017


Biopoin


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


EU/1/09/565


14.6.2017




12.6.2017


Stivarga


Bayer Pharma AG
D-13342 Berlin, Deutschland


EU/1/13/858


14.6.2017




15.6.2017


AUBAGIO


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


EU/1/13/838


19.6.2017




15.6.2017


Clopidogrel Mylan


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


EU/1/09/559


19.6.2017




15.6.2017


Eporatio


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


EU/1/09/573


19.6.2017




15.6.2017


Nexium Control


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


EU/1/13/860


19.6.2017




15.6.2017


Zometa


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


EU/1/01/176


19.6.2017




16.6.2017


Atriance


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


EU/1/07/403


20.6.2017




16.6.2017


Capecitabine medac


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


EU/1/12/802


20.6.2017




16.6.2017


Clopidogrel ratiopharm GmbH


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


EU/1/09/541


20.6.2017




16.6.2017


Cubicin


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


EU/1/05/328


20.6.2017




16.6.2017


INCRELEX


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


EU/1/07/402


20.6.2017




16.6.2017


Intuniv


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


EU/1/15/1040


20.6.2017




16.6.2017


KEYTRUDA


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


EU/1/15/1024


20.6.2017




16.6.2017


Sirturo


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


EU/1/13/901


21.6.2017




16.6.2017


Sivextro


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


EU/1/15/991


20.6.2017




16.6.2017


Translarna


PTC Therapeutics International Limited
5th Floor, 3 Grand Canal Plaza, Grand Canal Street Upper, Dublin 4, D04 EE70, Ireland


EU/1/13/902


20.6.2017




16.6.2017


Trizivir


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


EU/1/00/156


20.6.2017




16.6.2017


Trulicity


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


EU/1/14/956


20.6.2017




16.6.2017


Xagrid


Shire Pharmaceutical Contracts Ltd
Hampshire International Business Park, Chineham, Basingstoke, Hampshire RG24 8EP, United Kingdom


EU/1/04/295


20.6.2017




16.6.2017


Xgeva


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


EU/1/11/703


20.6.2017




16.6.2017


Yondelis


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


EU/1/07/417


20.6.2017




16.6.2017


Zoledronic acid Hospira


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


EU/1/12/800


20.6.2017




16.6.2017


Zoledronic acid medac


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


EU/1/12/779


20.6.2017




23.6.2017


ALPROLIX


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


EU/1/16/1098


28.6.2017




23.6.2017


Clopidogrel Teva


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


EU/1/09/540


27.6.2017




23.6.2017


Emselex


Merus Labs Luxco S.à R.L.
26-28, rue Edward Steichen, L-2540 Luxembourg


EU/1/04/294


27.6.2017




23.6.2017


Evra


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


EU/1/02/223


27.6.2017




23.6.2017


Farydak


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


EU/1/15/1023


27.6.2017




23.6.2017


Flixabi


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


EU/1/16/1106


27.6.2017




23.6.2017


Izba


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


EU/1/13/905


27.6.2017




23.6.2017


KEYTRUDA


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


EU/1/15/1024


27.6.2017




23.6.2017


Mysimba


Orexigen Therapeutics Ireland Limited
2nd Floor, Palmerston House, Fenian Street, Dublin 2, Ireland


EU/1/14/988


27.6.2017




23.6.2017


Pandemic influenza vaccine H5N1 AstraZeneca


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/16/1089


28.6.2017




23.6.2017


Prolia


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


EU/1/10/618


27.6.2017




23.6.2017


Rapamune


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


EU/1/01/171


27.6.2017




23.6.2017


Revestive


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


EU/1/12/787


27.6.2017




23.6.2017


Sebivo


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


EU/1/07/388


27.6.2017




23.6.2017


Sevelamer carbonate Zentiva


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


EU/1/14/952


27.6.2017




23.6.2017


Tadalafil Mylan


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


EU/1/14/961


27.6.2017




23.6.2017


Xarelto


Bayer AG
D-51368 Leverkusen, Deutschland


EU/1/08/472


27.6.2017




23.6.2017


Zykadia


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


EU/1/15/999


27.6.2017




26.6.2017


Grastofil


Apotex Europe B.V.
Darwinweg 20, NL-2333 CR Leiden, Nederland


EU/1/13/877


28.6.2017




26.6.2017


Komboglyze


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/11/731


28.6.2017




26.6.2017


Macugen


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


EU/1/05/325


28.6.2017




26.6.2017


Noxafil


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


EU/1/05/320


28.6.2017




26.6.2017


Onglyza


AstraZeneca AB
SE-151 85 Södertälje, Sverige


EU/1/09/545


28.6.2017




26.6.2017


Pregabalin Accord


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


EU/1/15/1027


28.6.2017




26.6.2017


Renvela


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


EU/1/09/521


28.6.2017




26.6.2017


Triumeq


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


EU/1/14/940


28.6.2017




26.6.2017


Voriconazole Accord


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


EU/1/13/835


28.6.2017




29.6.2017


alli


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


EU/1/07/401


3.7.2017




29.6.2017


Clopidogrel HCS


HCS bvba
H. Kennisstraat 53, B-2650 Edegem, België


EU/1/10/651


4.7.2017




29.6.2017


Clopidogrel ratiopharm


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


EU/1/14/975


3.7.2017




29.6.2017


Ibandronic acid Sandoz


Sandoz GmbH
Biochemiestrasse 10, A-6250 Kundl, Österreich


EU/1/11/685


3.7.2017




29.6.2017


IKERVIS


Santen Oy
Niittyhaankatu 20, FI-33720 Tampere, Suomi


EU/1/15/990


3.7.2017




29.6.2017


Uptravi


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


EU/1/15/1083


3.7.2017




29.6.2017


Vizamyl


GE Healthcare Ltd
Amersham Place, Little Chalfont, Buckinghamshire HP7 9NA, United Kingdom


EU/1/14/941


3.7.2017




29.6.2017


Xyrem


UCB Pharma Ltd
208 Bath Road, Slough, Berkshire SL1 3WE, United Kingdom


EU/1/05/312


3.7.2017










—



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




2.6.2017


Removab


Neovii Biotech GmbH
Am Haag 6-7, 82166 Graefelfing, Deutschland


EU/1/09/512


7.6.2017




15.6.2017


Clopidogrel Teva Pharma


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


EU/1/09/561


19.6.2017




23.6.2017


Zontivity


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


EU/1/14/976


27.6.2017










—



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




19.6.2017


Prevomax


maropitant


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


EU/2/17/211


Solution for injection


QA04AD90


21.6.2017




27.6.2017


CLYNAV


Salmon pancreas disease vaccine (recombinant DNA plasmid)


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


EU/2/16/197


Solution for injection


QI10AX


29.6.2017










—



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




6.6.2017


Advocate


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/03/039


8.6.2017




7.6.2017


Econor


Elanco Europe Ltd.
Lilly House, Priestley Road, Basingstoke, RG24 9NL UNITED KINGDOM


EU/2/98/010


9.6.2017




8.6.2017


Cardalis


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


EU/2/12/142


12.6.2017




13.6.2017


BROADLINE


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


EU/2/13/157


15.6.2017




13.6.2017


Circovac


Ceva-Phylaxia Zrt.
1107 Budapest, Szállás u. 5., MAGYARORSZÁG


EU/2/07/075


15.6.2017




13.6.2017


Clomicalm


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


EU/2/98/007


15.6.2017




13.6.2017


Veraflox


Bayer Animal Health GmbH
D-51368 Leverkusen, Deutschland


EU/2/10/107


16.6.2017




29.6.2017


EQUIOXX


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


EU/2/08/083


3.7.2017




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.