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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)
Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. juulist 2017 kuni 31. augustini 2017 (Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38)
Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. juulist 2017 kuni 31. augustini 2017 (Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38)
ELT 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 |
ET |
Euroopa Liidu Teataja |
C 328/1 |
Ravimite müügilubasid käsitlevate Euroopa Liidu otsuste kokkuvõte alates 1. juulist 2017 kuni 31. augustini 2017
(Avaldatud vastavalt Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artiklile 13 või 38 (1))
(2017/C 328/01)
|
— |
Müügiloa väljaandmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 13): Heaks kiidetud |
|
Otsuse tegemise kuupäev |
Ravimi nimetus |
Rahvusvaheline mittekaubanduslik nimetus (INN) |
Müügiloa omanik |
Kande number ühenduse registris |
Ravimivorm |
ATC-kood (anatoomilis-terapeutiline keemiline kood) |
Teatamise kuupäev |
|
6.7.2017 |
OXERVATE |
tsenegermiini |
Dompé farmaceutici S.p.A. Via Santa Lucia 6, 20122 Milano, Italia |
EU/1/17/1197 |
Silmatilgad, lahus |
Pending |
10.7.2017 |
|
10.7.2017 |
Spherox |
maatriksiga seotud autoloogsed inimese kondrotsüütide sferoidid |
CO.DON AG Warthestraße 21, 14513 Teltow, Deutschland |
EU/1/17/1181 |
Implanteeritav rakususpensioon |
M09AX02 |
12.7.2017 |
|
13.7.2017 |
Blitzima |
rituksimaab |
Celltrion Healthcare Hungary Kft. 1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország |
EU/1/17/1205 |
Kontsentraat infusioonilahuse valmistamiseks |
L01XC02 |
17.7.2017 |
|
13.7.2017 |
Reagila |
kariprasiinile |
Gedeon Richter Plc. Gyömrői út 19-21., H-1103 Budapest, Magyarország |
EU/1/17/1209 |
Kõvakapsel |
N05AX15 |
17.7.2017 |
|
13.7.2017 |
Ritemvia |
rituksimaab |
Celltrion Healthcare Hungary Kft. 1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország |
EU/1/17/1207 |
Kontsentraat infusioonilahuse valmistamiseks |
L01XC02 |
17.7.2017 |
|
13.7.2017 |
Tuxella |
rituksimaab |
Celltrion Healthcare Hungary Kft. 1051 Budapest, Bajcsy-Zsilinszky út 12., 4. em. 410, Magyarország |
EU/1/17/1206 |
Kontsentraat infusioonilahuse valmistamiseks |
L01XC02 |
17.7.2017 |
|
17.7.2017 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Zentiva |
efavirensi/emtritsitabiini/tenofoviirdisoproksiili |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika |
EU/1/17/1210 |
Õhukese polümeerikattega tablett |
J05AR06 |
19.7.2017 |
|
17.7.2017 |
Kyntheum |
brodalumab |
Leo Pharma A/S Industriparken 55, DK-2750 Ballerup, Danmark |
EU/1/16/1155 |
Süstelahus |
L04AC12 |
19.7.2017 |
|
17.7.2017 |
Trimbow |
beklometasoon/formoterool/glükopürroonbromiid |
Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/17/1208 |
Inhalatsiooniaerosool, lahus |
R03AL09 |
19.7.2017 |
|
19.7.2017 |
Insulin lispro Sanofi |
lispro-insuliin |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/17/1203 |
Süstelahus |
A10AB04 |
21.7.2017 |
|
19.7.2017 |
Veltassa |
patiromeer |
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 |
Suukaudse suspensiooni pulber |
V03AE09 |
21.7.2017 |
|
26.7.2017 |
Maviret |
gletsapreviir/pibrentasviir |
AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom |
EU/1/17/1213 |
Õhukese polümeerikattega tablett |
J05AX |
28.7.2017 |
|
26.7.2017 |
Vosevi |
sofosbuviir/velpatasviir/voksilapreviir |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/17/1223 |
Õhukese polümeerikattega tablett |
Pending |
28.7.2017 |
|
26.7.2017 |
Zykadia |
tseritiniib |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/15/999 |
Kõvakapsel |
L01XE28 |
28.7.2017 |
|
22.8.2017 |
Kisqali |
ribotsikliib |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/17/1221 |
Õhukese polümeerikattega tablett |
L01XE42 |
24.8.2017 |
|
22.8.2017 |
MAVENCLAD |
kladribiin |
Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom |
EU/1/17/1212 |
Tablett |
L01BB04 |
24.8.2017 |
|
24.8.2017 |
Fotivda |
tivosaniib |
EUSA Pharma (UK) Limited Breakspear Park, Breakspear Way, HP2 4TZ, Hemel Hempstead, United Kingdom |
EU/1/17/1215 |
Kõvakapsel |
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 |
Süstelahus |
L04AB04 |
29.8.2017 |
|
24.8.2017 |
Nitisinone MendeliKABS |
nitisinoon |
MendeliKABS Europe Limited Office 7, Gateway 1000, Whittle Way, Stevenage, Hertfordshire, SG1 2FP, United Kingdom |
EU/1/17/1217 |
Kõvakapsel |
A16AX04 |
29.8.2017 |
|
— |
Müügiloa muutmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 13): Heaks kiidetud |
|
Otsuse tegemise kuupäev |
Ravimi nimetus |
Müügiloa omanik |
Kande number ühenduse registris |
Teatamise kuupäev |
|
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 |
Olansapiin 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 |
|
— |
Müügiloa tühistamine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 13) |
|
Otsuse tegemise kuupäev |
Ravimi nimetus |
Müügiloa omanik |
Kande number ühenduse registris |
Teatamise kuupäev |
|
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 |
|
— |
Müügiloa väljaandmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 38): Heaks kiidetud |
|
Otsuse tegemise kuupäev |
Ravimi nimetus |
Rahvusvaheline mittekaubanduslik nimetus (INN) |
Müügiloa omanik |
Kande number ühenduse registris |
Ravimivorm |
ATC-kood (anatoomilis-terapeutiline keemiline kood) |
Teatamise kuupäev |
|
17.8.2017 |
VEPURED |
E. coli verotoksoidvaktsiin (inaktiveeritud rekombinantne) |
Laboratorios Hipra, S.A. Avda. La Selva, 135, 17170 Amer (Girona), España |
EU/2/17/214 |
Süstesuspensioon |
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 |
Lahus joogivees manustamiseks |
QP53BE02 |
22.8.2017 |
|
22.8.2017 |
Innovax-ND-IBD |
Newcastle’i haiguse, lindude nakkava bursiidi ja Mareki haiguse (elus rekombinantne) vastane vaktsiin. |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/17/213 |
Suspensioon ja lahusti süstesuspensiooni valmistamiseks |
QI01AD |
24.8.2017 |
|
24.8.2017 |
Suvaxyn PRRS MLV |
Sigade reproduktiiv-respiratoorse sündroomi viiruse vaktsiin (elus) |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/17/215 |
Süstesuspensiooni lüofilisaat ja lahusti |
QI09AD03 |
28.8.2017 |
|
— |
Müügiloa muutmine (Euroopa Parlamendi ja nõukogu määruse (EÜ) nr 726/2004 artikkel 38): Heaks kiidetud |
|
Otsuse tegemise kuupäev |
Ravimi nimetus |
Müügiloa omanik |
Kande number ühenduse registris |
Teatamise kuupäev |
|
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 |
Kõnealuseid ravimeid käsitleva avaliku hindamisaruandega ja vastavate otsustega tutvuda soovijatel palutakse pöörduda:
|
European Medicines Agency |
|
30 Churchill Place |
|
Canary Wharf |
|
London E14 5EU |
|
United Kingdom |
(1) ELT L 136, 30.4.2004, lk 1.