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Document 52017XC0929(02)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2017 to 31 August 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 July 2017 to 31 August 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 July 2017 to 31 August 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 328, 29.9.2017, p. 1–13
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
29.9.2017 |
EN |
Official Journal of the European Union |
C 328/1 |
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 July 2017 to 31 August 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 328/01)
|
— |
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 |
|
6.7.2017 |
OXERVATE |
cenegermin |
Dompé farmaceutici S.p.A. Via Santa Lucia 6, 20122 Milano, Italia |
EU/1/17/1197 |
Eye drops, solution |
Pending |
10.7.2017 |
|
10.7.2017 |
Spherox |
spheroids of human autologous matrix-associated chondrocytes |
CO.DON AG Warthestraße 21, 14513 Teltow, Deutschland |
EU/1/17/1181 |
Implantation suspension |
M09AX02 |
12.7.2017 |
|
13.7.2017 |
Blitzima |
rituximab |
Celltrion Healthcare Hungary Kft. 1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország |
EU/1/17/1205 |
Concentrate for solution for infusion |
L01XC02 |
17.7.2017 |
|
13.7.2017 |
Reagila |
cariprazine |
Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország |
EU/1/17/1209 |
Capsule, hard |
N05AX15 |
17.7.2017 |
|
13.7.2017 |
Ritemvia |
rituximab |
Celltrion Healthcare Hungary Kft. 1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország |
EU/1/17/1207 |
Concentrate for solution for infusion |
L01XC02 |
17.7.2017 |
|
13.7.2017 |
Tuxella |
rituximab |
Celltrion Healthcare Hungary Kft. 1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország |
EU/1/17/1206 |
Concentrate for solution for infusion |
L01XC02 |
17.7.2017 |
|
17.7.2017 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva |
efavirenz/emtricitabine/tenofovir disoproxil |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/17/1210 |
Film-coated tablet |
J05AR06 |
19.7.2017 |
|
17.7.2017 |
Kyntheum |
brodalumab |
Leo Pharma A/S Industriparken 55, DK-2750 Ballerup, Danmark |
EU/1/16/1155 |
Solution for injection |
L04AC12 |
19.7.2017 |
|
17.7.2017 |
Trimbow |
beclometasone/formoterol/glycopyrronium bromide |
Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/17/1208 |
Pressurised inhalation, solution |
R03AL09 |
19.7.2017 |
|
19.7.2017 |
Insulin lispro Sanofi |
insulin lispro |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/17/1203 |
Solution for injection |
A10AB04 |
21.7.2017 |
|
19.7.2017 |
Veltassa |
patiromer |
Vifor Fresenius Medical Care Renal Pharma France 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France |
EU/1/17/1179 |
Powder for oral suspension |
V03AE09 |
21.7.2017 |
|
26.7.2017 |
Maviret |
glecaprevir/pibrentasvir |
AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom |
EU/1/17/1213 |
Film-coated tablet |
J05AX |
28.7.2017 |
|
26.7.2017 |
Vosevi |
sofosbuvir/velpatasvir/voxilaprevir |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/17/1223 |
Film-coated tablet |
Pending |
28.7.2017 |
|
26.7.2017 |
Zykadia |
ceritinib |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/15/999 |
Capsule, hard |
L01XE28 |
28.7.2017 |
|
22.8.2017 |
Kisqali |
ribociclib |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/17/1221 |
Film-coated tablet |
L01XE42 |
24.8.2017 |
|
22.8.2017 |
MAVENCLAD |
cladribine |
Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom |
EU/1/17/1212 |
Tablet |
L01BB04 |
24.8.2017 |
|
24.8.2017 |
Fotivda |
tivozanib |
EUSA Pharma (UK) Limited Breakspear Park, Breakspear Way, HP2 4TZ, Hemel Hempstead, United Kingdom |
EU/1/17/1215 |
Capsule, hard |
L01XE34 |
29.8.2017 |
|
24.8.2017 |
Imraldi |
adalimumab |
Samsung Bioepis UK Limited 5th floor, Profile West, 950 Great West Road, Brentford, Middlesex TW8 9ES, United Kingdom |
EU/1/17/1216 |
Solution for injection |
L04AB04 |
29.8.2017 |
|
24.8.2017 |
Nitisinone MendeliKABS |
nitisinone |
MendeliKABS Europe Limited Office 7, Gateway 1000, Whittle Way, Stevenage, Hertfordshire, SG1 2FP, United Kingdom |
EU/1/17/1217 |
Capsule, hard |
A16AX04 |
29.8.2017 |
|
— |
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 |
|
6.7.2017 |
Celsentri |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/07/418 |
10.7.2017 |
|
6.7.2017 |
Clopidogrel Krka d.d. |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/09/562 |
10.7.2017 |
|
6.7.2017 |
Imlygic |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/15/1064 |
10.7.2017 |
|
6.7.2017 |
Kivexa |
ViiV Healthcare UK Limited 980 Great West Road, Brentford, Middlesex TW8 9GS, United Kingdom |
EU/1/04/298 |
10.7.2017 |
|
6.7.2017 |
Nexavar |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/06/342 |
10.7.2017 |
|
6.7.2017 |
Toviaz |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/07/386 |
10.7.2017 |
|
10.7.2017 |
Memantine Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/13/880 |
12.7.2017 |
|
10.7.2017 |
Myozyme |
Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland |
EU/1/06/333 |
12.7.2017 |
|
10.7.2017 |
Xeloda |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/00/163 |
12.7.2017 |
|
13.7.2017 |
Edistride |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/15/1052 |
17.7.2017 |
|
13.7.2017 |
Enurev Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/12/789 |
17.7.2017 |
|
13.7.2017 |
Eylea |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/12/797 |
17.7.2017 |
|
13.7.2017 |
Incruse |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/14/922 |
17.7.2017 |
|
13.7.2017 |
Isentress |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/07/436 |
17.7.2017 |
|
13.7.2017 |
Kuvan |
BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland |
EU/1/08/481 |
17.7.2017 |
|
13.7.2017 |
Latuda |
Sunovion Pharmaceuticals Europe Ltd First Floor, Southside, 97-105 Victoria Street, London SW1E 6QT, United Kingdom |
EU/1/14/913 |
17.7.2017 |
|
13.7.2017 |
Lixiana |
Daiichi Sankyo Europe GmbH Zielstattstrasse 48, D-81379 München, Deutschland |
EU/1/15/993 |
17.7.2017 |
|
13.7.2017 |
Memantine Merz |
Merz Pharmaceuticals GmbH Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland |
EU/1/12/799 |
17.7.2017 |
|
13.7.2017 |
Picato |
LEO Laboratories Ltd. 285 Cashel Road, Crumlin, Dublin 12, Ireland |
EU/1/12/796 |
17.7.2017 |
|
13.7.2017 |
Praxbind |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/15/1056 |
17.7.2017 |
|
13.7.2017 |
Torisel |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/07/424 |
17.7.2017 |
|
13.7.2017 |
Xaluprine |
Nova Laboratories Limited Martin House, Gloucester Crescent, Wigston Leicester, LE18 4YL, United Kingdom |
EU/1/11/727 |
17.7.2017 |
|
13.7.2017 |
Xultophy |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/14/947 |
17.7.2017 |
|
13.7.2017 |
Zalmoxis |
MolMed S.p.A. Via Olgettina 58, I-20132 Milano, Italia |
EU/1/16/1121 |
17.7.2017 |
|
13.7.2017 |
Zoledronic acid Accord |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/13/834 |
17.7.2017 |
|
14.7.2017 |
Zinbryta |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/16/1107 |
18.7.2017 |
|
17.7.2017 |
Dinutuximab beta Apeiron |
EUSA Pharma (UK) Limited Breakspear Park, Breakspear Way, HP2 4TZ, Hemel Hempstead, United Kingdom |
EU/1/17/1191 |
19.7.2017 |
|
17.7.2017 |
Inhixa |
Techdow Europe AB Kåbovägen 32, 75236 Uppsala, Sverige |
EU/1/16/1132 |
20.7.2017 |
|
17.7.2017 |
Opsumit |
Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
EU/1/13/893 |
19.7.2017 |
|
17.7.2017 |
Rivastigmine Sandoz |
Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich |
EU/1/09/599 |
19.7.2017 |
|
17.7.2017 |
Thorinane |
Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11, 1077XX Amsterdam, Nederland |
EU/1/16/1131 |
19.7.2017 |
|
17.7.2017 |
Zinforo |
Pfizer Ireland Pharmaceuticals Operations Services Group, Ringaskiddy, County Cork, Ireland |
EU/1/12/785 |
19.7.2017 |
|
19.7.2017 |
Clopidogrel BGR |
Laboratoires BIOGARAN 15 boulevard Charles de Gaulle, 92707 Colombes Cedex, France |
EU/1/09/558 |
21.7.2017 |
|
19.7.2017 |
Clopidogrel Krka |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/09/556 |
21.7.2017 |
|
19.7.2017 |
Clopidogrel TAD |
TAD Pharma GmbH Heinz-Lohmann-Straße 5, D-27472 Cuxhaven, Deutschland |
EU/1/09/555 |
21.7.2017 |
|
19.7.2017 |
Cuprymina |
SPARKLE S.r.l. Località Cavallino, 62010 Montecosaro (MC), Italia |
EU/1/12/784 |
24.7.2017 |
|
19.7.2017 |
Forxiga |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/12/795 |
24.7.2017 |
|
19.7.2017 |
Grepid |
Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα |
EU/1/09/535 |
21.7.2017 |
|
19.7.2017 |
Harvoni |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/14/958 |
24.7.2017 |
|
19.7.2017 |
Jardiance |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/14/930 |
21.7.2017 |
|
19.7.2017 |
Ofev |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/14/979 |
21.7.2017 |
|
19.7.2017 |
Qtern |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/16/1108 |
24.7.2017 |
|
19.7.2017 |
Raxone |
Santhera Pharmaceuticals (Deutschland) GmbH Marie-Curie Strasse 8, D-79539 Lörrach, Deutschland |
EU/1/15/1020 |
24.7.2017 |
|
19.7.2017 |
Revolade |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/612 |
21.7.2017 |
|
19.7.2017 |
Seebri Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/12/788 |
21.7.2017 |
|
19.7.2017 |
Synjardy |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/15/1003 |
21.7.2017 |
|
19.7.2017 |
Tracleer |
Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
EU/1/02/220 |
21.7.2017 |
|
19.7.2017 |
Zavesca |
Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
EU/1/02/238 |
21.7.2017 |
|
19.7.2017 |
Zavicefta |
Pfizer Ireland Pharmaceuticals Operations Services Group, Ringaskiddy, County Cork, Ireland |
EU/1/16/1109 |
24.7.2017 |
|
25.7.2017 |
Faslodex |
AstraZeneca UK Limited Charter Way, Macclesfield, Cheshire, SK10 2NA, United Kingdom |
EU/1/03/269 |
27.7.2017 |
|
25.7.2017 |
Granupas |
Lucane Pharma 172 rue de Charonne, 75011 Paris, France |
EU/1/13/896 |
27.7.2017 |
|
25.7.2017 |
Olanzapine Mylan |
Generics [UK] Limited Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom |
EU/1/08/475 |
31.7.2017 |
|
25.7.2017 |
Orencia |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/07/389 |
27.7.2017 |
|
25.7.2017 |
Rivastigmine 1 A Pharma |
1 A Pharma GmbH Keltenring 1 + 3, D-82041 Oberhaching, Deutschland |
EU/1/09/585 |
28.7.2017 |
|
25.7.2017 |
Victoza |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/09/529 |
27.7.2017 |
|
25.7.2017 |
Voncento |
CSL Behring GmbH Emil-von-Behring-Straße 76, D-35041 Marburg, Deutschland |
EU/1/13/857 |
28.7.2017 |
|
26.7.2017 |
Aripiprazole Mylan Pharma |
Mylan S.A.S 117 allée des Parcs, F-69800 Saint Priest, France |
EU/1/15/1005 |
28.7.2017 |
|
26.7.2017 |
Bridion |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/08/466 |
28.7.2017 |
|
26.7.2017 |
Kaletra |
AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom |
EU/1/01/172 |
28.7.2017 |
|
26.7.2017 |
Oprymea |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/08/469 |
28.7.2017 |
|
26.7.2017 |
Tovanor Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/12/790 |
28.7.2017 |
|
26.7.2017 |
Velphoro |
Vifor Fresenius Medical Care Renal Pharma France 100-101 Terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France |
EU/1/14/943 |
28.7.2017 |
|
26.7.2017 |
Votubia |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/11/710 |
28.7.2017 |
|
26.7.2017 |
Yellox |
PharmaSwiss Česká republika s.r.o. Jankovcova 1569/2c 17000 Praha 7 Česká republika |
EU/1/11/692 |
28.7.2017 |
|
2.8.2017 |
Stivarga |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/13/858 |
4.8.2017 |
|
2.8.2017 |
Zyllt |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/09/553 |
4.8.2017 |
|
3.8.2017 |
Abilify |
Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |
EU/1/04/276 |
17.8.2017 |
|
3.8.2017 |
Apidra |
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland |
EU/1/04/285 |
7.8.2017 |
|
7.8.2017 |
Colobreathe |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/11/747 |
9.8.2017 |
|
7.8.2017 |
Nordimet |
Nordic Group B.V. Siriusdreef 22, NL-2132 WT Hoofddorp, Nederland |
EU/1/16/1124 |
9.8.2017 |
|
7.8.2017 |
Stivarga |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/13/858 |
9.8.2017 |
|
14.8.2017 |
Exjade |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/06/356 |
17.8.2017 |
|
14.8.2017 |
Mekinist |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/14/931 |
18.8.2017 |
|
14.8.2017 |
Soliris |
Alexion Europe SAS 1-15 avenue Edouard Belin, 92500 Rueil-Malmaison, France |
EU/1/07/393 |
17.8.2017 |
|
14.8.2017 |
Vargatef |
Boehringer Ingelheim International GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/1/14/954 |
17.8.2017 |
|
14.8.2017 |
Xofigo |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/13/873 |
17.8.2017 |
|
22.8.2017 |
CoAprovel |
Sanofi Clir SNC 54 rue La Boétie, F-75008 Paris, France |
EU/1/98/086 |
24.8.2017 |
|
22.8.2017 |
Ketoconazole HRA |
Laboratoire HRA Pharma 15 rue Béranger, F-75003 Paris, France |
EU/1/14/965 |
24.8.2017 |
|
22.8.2017 |
Rasilez |
Noden Pharma DAC D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland |
EU/1/07/405 |
24.8.2017 |
|
22.8.2017 |
SonoVue |
Bracco International B.V. Strawinskylaan 3051, NL-1077 ZX Amsterdam, Nederland |
EU/1/01/177 |
24.8.2017 |
|
22.8.2017 |
Xarelto |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/08/472 |
24.8.2017 |
|
24.8.2017 |
Aranesp |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/01/185 |
28.8.2017 |
|
24.8.2017 |
BYDUREON |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/11/696 |
28.8.2017 |
|
24.8.2017 |
Dacogen |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/12/792 |
28.8.2017 |
|
24.8.2017 |
EDURANT |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/11/736 |
28.8.2017 |
|
24.8.2017 |
Fluenz Tetra |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/13/887 |
28.8.2017 |
|
24.8.2017 |
IMBRUVICA |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/14/945 |
28.8.2017 |
|
24.8.2017 |
Invega |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/07/395 |
28.8.2017 |
|
24.8.2017 |
Kaletra |
AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom |
EU/1/01/172 |
29.8.2017 |
|
24.8.2017 |
Karvezide |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/98/085 |
28.8.2017 |
|
24.8.2017 |
KEYTRUDA |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/15/1024 |
29.8.2017 |
|
24.8.2017 |
Norvir |
AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom |
EU/1/96/016 |
29.8.2017 |
|
24.8.2017 |
Orkambi |
Vertex Pharmaceuticals (Europe) Limited 2 Kingdom Street, London W2 6BD, United Kingdom |
EU/1/15/1059 |
29.8.2017 |
|
24.8.2017 |
Ruconest |
Pharming Group N.V. Darwinweg 24, NL-2333 CR Leiden, Nederland |
EU/1/10/641 |
28.8.2017 |
|
24.8.2017 |
Zoledronic acid Hospira |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom |
EU/1/12/800 |
29.8.2017 |
|
28.8.2017 |
Constella |
Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland |
EU/1/12/801 |
30.8.2017 |
|
28.8.2017 |
Ecalta |
Pfizer Limited Ramsgate Road, Sandwich, Kent CT13 9NJ, United Kingdom |
EU/1/07/416 |
30.8.2017 |
|
28.8.2017 |
Forxiga |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/12/795 |
30.8.2017 |
|
28.8.2017 |
Irbesartan HCT Zentiva |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/06/377 |
30.8.2017 |
|
28.8.2017 |
Mimpara |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/04/292 |
30.8.2017 |
|
28.8.2017 |
Rasilez HCT |
Noden Pharma DAC D'Olier Chambers, 16A D'Olier Street, Dublin 2, Ireland |
EU/1/08/491 |
30.8.2017 |
|
— |
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 |
|
19.7.2017 |
Enzepi |
Allergan Pharmaceuticals International Limited Clonshaugh Industrial Estate, Coolock, Dublin 17, Ireland |
EU/1/16/1113 |
21.7.2017 |
|
19.7.2017 |
Repso |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/11/674 |
21.7.2017 |
|
— |
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 |
|
17.8.2017 |
VEPURED |
E. coli verotoxoid vaccine (inactivated recombinant) |
Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España |
EU/2/17/214 |
Suspension for injection |
QI09AB02 |
21.8.2017 |
|
18.8.2017 |
Exzolt |
fluralaner |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/17/212 |
Solution for use in drinking water |
QP53BE02 |
22.8.2017 |
|
22.8.2017 |
Innovax-ND-IBD |
Newcastle disease, infectious bursal disease and Marek's disease vaccine (live recombinant) |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/17/213 |
Suspension and solvent for suspension for injection |
QI01AD |
24.8.2017 |
|
24.8.2017 |
Suvaxyn PRRS MLV |
Porcine respiratory and reproductive syndrome virus vaccine (live) |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/17/215 |
Lyophilisate and solvent for suspension for injection |
QI09AD03 |
28.8.2017 |
|
— |
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 |
|
10.7.2017 |
Onsior |
Elanco Europe Ltd. Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom |
EU/2/08/089 |
12.7.2017 |
|
14.7.2017 |
Nobilis IB Primo QX |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/14/174 |
18.7.2017 |
|
14.7.2017 |
Zolvix |
Elanco Europe Ltd. Lilly House, Priestley Road, Basingstoke, Hampshire, RG24 9NL, United Kingdom |
EU/2/09/101 |
18.7.2017 |
|
19.7.2017 |
Aivlosin |
ECO Animal Health Ltd 78 Coombe Road, New Malden, Surrey KT3 4QS United Kingdom |
EU/2/04/044 |
21.7.2017 |
|
28.7.2017 |
Loxicom |
Norbrook Laboratories Ltd Station Works, Newry, Co. Down, BT35 6JP, United Kindgom |
EU/2/08/090 |
1.8.2017 |
|
28.7.2017 |
Vaxxitek HVT + IBD |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/02/032 |
1.8.2017 |
|
3.8.2017 |
BLUEVAC BTV8 |
CZ Veterinaria, S.A. La Relva s/n, 36400 Porriño, España |
EU/2/11/122 |
7.8.2017 |
|
10.8.2017 |
Canigen L4 |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/15/183 |
14.8.2017 |
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.