EUR-Lex Access to European Union law
This document is an excerpt from the EUR-Lex website
Document 52017XC0728(01)
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)
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)
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)
OJ C 245, 28.7.2017, p. 1–11
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
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.