This document is an excerpt from the EUR-Lex website
Document 52017XC1027(01)
Summary of European Union decisions on marketing authorisations in respect of medicinal products from 1 September 2017 to 30 September 2017 (Published pursuant to Article 13 or Article 38 of Regulation (EC) No 726/2004 of the European Parliament and of the Council)
Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 septembrie 2017 până la 30 septembrie 2017 [Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]
Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 septembrie 2017 până la 30 septembrie 2017 [Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]
JO C 367, 27.10.2017, pp. 1–10
(BG, ES, CS, DA, DE, ET, EL, EN, FR, HR, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)
|
27.10.2017 |
RO |
Jurnalul Oficial al Uniunii Europene |
C 367/1 |
Rezumatul deciziilor Uniunii Europene privind autorizațiile de introducere pe piață pentru medicamentele de la 1 septembrie 2017 până la 30 septembrie 2017
[Publicat în temeiul articolului 13 sau al articolului 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului (1)]
(2017/C 367/01)
|
— |
Emiterea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat |
|
Data deciziei |
Denumirea medicamentului |
DCI (Denumirea Comună Internațională) |
Titularul autorizației de introducere pe piață |
Numărul de înregistrare în Registrul comunitar |
Formă farmaceutică |
Codul ATC (Codul Anatomic-Terapeutic-Chimic) |
Data notificării |
|
5.9.2017 |
Cuprior |
trientină |
gmp-orphan SA Pépinière Paris Santé Cochin, 27-29 rue Faubourg Saint-Jacques, 75014 Paris, France |
EU/1/17/1199 |
Comprimat |
A16AX12 |
7.9.2017 |
|
5.9.2017 |
Efavirenz/Emtricitabine/Tenofovir disoproxil Mylan |
Efavirenz/emtricitabină/tenofovir disoproxil |
Mylan S.A.S. 117 Allée des Parcs, 69800 Saint-Priest, France |
EU/1/17/1222 |
Comprimat filmat |
J05AR06 |
7.9.2017 |
|
18.9.2017 |
Bavencio |
avelumab |
Merck Serono Europe Limited 56, Marsh Wall, London E14 9TP, United Kingdom |
EU/1/17/1214 |
Concentrat pentru soluţie perfuzabilă |
Pending |
20.9.2017 |
|
18.9.2017 |
Entecavir Mylan |
entecavir |
Mylan S.A.S. 117 Allée des Parcs, 69800 Saint-Priest, France |
EU/1/17/1227 |
Comprimat filmat |
J05AF10 |
20.9.2017 |
|
18.9.2017 |
Lacosamide Accord |
lacosamid |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/17/1230 |
Comprimat filmat |
N03AX18 |
20.9.2017 |
|
18.9.2017 |
Rydapt |
Midostaurin |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/17/1218 |
Capsule moi |
L01XE39 |
20.9.2017 |
|
18.9.2017 |
Xermelo |
telotristat |
Ipsen Pharma 65 quai Georges Gorse, F-92100 Boulogne-Billancourt, France |
EU/1/17/1224 |
Comprimat filmat |
Pending |
20.9.2017 |
|
21.9.2017 |
Symtuza |
darunavir/cobicistat/emtricitabină/tenofovir alafenamidă |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/17/1225 |
Comprimat filmat |
Pending |
25.9.2017 |
|
21.9.2017 |
Tecentriq |
atezolizumab |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/17/1220 |
Concentrat pentru soluţie perfuzabilă |
Pending |
25.9.2017 |
|
26.9.2017 |
Dupixent |
dupilumab |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/17/1229 |
Soluţie injectabilă |
Pending |
28.9.2017 |
|
26.9.2017 |
Entecavir Accord |
entecavir |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/17/1211 |
Comprimat filmat |
J05AF10 |
28.9.2017 |
|
26.9.2017 |
Lutathera |
oxodotreotidă de lutețiu (177Lu) |
Advanced Accelerator Applications 20 rue Diesel, F-01630 Saint-Genis-Pouilly, France |
EU/1/17/1226 |
Soluţie perfuzabilă |
V10XX04 |
28.9.2017 |
|
— |
Modificarea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat |
|
Data deciziei |
Denumirea medicamentului |
Titularul autorizației de introducere pe piață |
Numărul de înregistrare în Registrul comunitar |
Data notificării |
|
5.9.2017 |
Humira |
AbbVie Ltd Maidenhead, SL6 4UB, United Kingdom |
EU/1/03/256 |
7.9.2017 |
|
5.9.2017 |
Olazax |
Glenmark Pharmaceuticals s.r.o. Hvězdova 1716/2b, 140 78 Praha 4, Česká republika. |
EU/1/09/597 |
7.9.2017 |
|
5.9.2017 |
Thorinane |
Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11, 1077XX Amsterdam, Nederland |
EU/1/16/1131 |
7.9.2017 |
|
7.9.2017 |
Binocrit |
Sandoz GmbH Biochemiestrasse 10, A-6250 Kundl, Österreich |
EU/1/07/410 |
11.9.2017 |
|
7.9.2017 |
Epoetin alfa Hexal |
Hexal AG Industriestrasse 25, D-83607 Holzkirchen, Deutschland |
EU/1/07/411 |
11.9.2017 |
|
7.9.2017 |
Fexeric |
Keryx Biopharma UK Ltd. Riverbank House, 2 Swan Lane, London, EC4R 3TT, United Kingdom |
EU/1/15/1039 |
11.9.2017 |
|
7.9.2017 |
Intanza |
Sanofi Pasteur Europe 2 Avenue Pont Pasteur, 69007 Lyon, France |
EU/1/08/505 |
11.9.2017 |
|
7.9.2017 |
Taltz |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/15/1085 |
11.9.2017 |
|
11.9.2017 |
Clorură de metiltioniniu Proveblue |
Provepharm S.A.S. 22 Rue Marc Donadille, 13013 Marseille, France |
EU/1/11/682 |
14.9.2017 |
|
11.9.2017 |
Infanrix hexa |
GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique |
EU/1/00/152 |
13.9.2017 |
|
11.9.2017 |
Januvia |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/07/383 |
13.9.2017 |
|
11.9.2017 |
Jinarc |
Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |
EU/1/15/1000 |
13.9.2017 |
|
11.9.2017 |
Neparvis |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/16/1103 |
13.9.2017 |
|
11.9.2017 |
Osseor |
Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France |
EU/1/04/287 |
13.9.2017 |
|
11.9.2017 |
Protelos |
Les Laboratoires Servier 50 rue Carnot, F-92284 Suresnes CEDEX, France |
EU/1/04/288 |
13.9.2017 |
|
11.9.2017 |
Simponi |
Janssen Biologics B.V. Einsteinweg 101, NL-2333 CB Leiden, Nederland |
EU/1/09/546 |
13.9.2017 |
|
11.9.2017 |
Tesavel |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/07/435 |
13.9.2017 |
|
11.9.2017 |
Tysabri |
Biogen Idec Limited Innovation House, 70 Norden Road, Maidenhead, Berkshire SL6 4AY, United Kingdom |
EU/1/06/346 |
13.9.2017 |
|
11.9.2017 |
Ventavis |
Bayer Pharma AG D-13342 Berlin, Deutschland |
EU/1/03/255 |
13.9.2017 |
|
11.9.2017 |
Votrient |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/628 |
13.9.2017 |
|
11.9.2017 |
Xelevia |
Merck Sharp & Dohme Limited Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, United Kingdom |
EU/1/07/382 |
13.9.2017 |
|
11.9.2017 |
Zerit |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/96/009 |
13.9.2017 |
|
11.9.2017 |
Zyprexa |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/96/022 |
13.9.2017 |
|
14.9.2017 |
Angiox |
The Medicines Company UK Ltd 115L Milton Park, Abingdon, Oxfordshire OX14 4SA, United Kingdom |
EU/1/04/289 |
18.9.2017 |
|
14.9.2017 |
Ebixa |
H. Lundbeck A/S Ottiliavej 9, DK-2500 Valby, Danmark |
EU/1/02/219 |
18.9.2017 |
|
14.9.2017 |
Eurartesim |
Alfasigma S.p.A. Viale Sarca, n. 223, 20126 Milano, Italia |
EU/1/11/716 |
21.9.2017 |
|
14.9.2017 |
Glidipion |
Actavis Group PTC ehf. Reykjavíkurvegi 76-78, 220 Hafnarfjörður, Íceland |
EU/1/12/756 |
18.9.2017 |
|
14.9.2017 |
Ifirmasta |
Krka, d. d., Novo Mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/08/480 |
18.9.2017 |
|
14.9.2017 |
Olanzapine Apotex |
Apotex Europe B.V. Darwinweg 20, NL- 2333 CR Leiden, Nederland |
EU/1/10/635 |
18.9.2017 |
|
14.9.2017 |
Olazax Disperzi |
Glenmark Pharmaceuticals s.r.o. City Tower, Hvězdova 1716/2b, CZ-14078 Praha 4, Česká republika |
EU/1/09/592 |
18.9.2017 |
|
14.9.2017 |
Sovaldi |
Gilead Sciences International Limited Cambridge CB21 6GT, United Kingdom |
EU/1/13/894 |
18.9.2017 |
|
14.9.2017 |
Trevicta |
Janssen-Cilag International NV Turnhoutseweg 30, B-2340 Beerse, België |
EU/1/14/971 |
18.9.2017 |
|
14.9.2017 |
Vimpat |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
EU/1/08/470 |
18.9.2017 |
|
14.9.2017 |
Wakix |
Bioprojet Pharma 9 rue Rameau, F-75002 Paris, France |
EU/1/15/1068 |
18.9.2017 |
|
18.9.2017 |
Abseamed |
Medice Arzneimittel Pütter GmbH & Co KG Kuhloweg 37, D-58638 Iserlohn, Deutschland |
EU/1/07/412 |
20.9.2017 |
|
18.9.2017 |
Acid ibandronic |
Accord Healthcare Limited Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom |
EU/1/12/798 |
20.9.2017 |
|
18.9.2017 |
Betmiga |
Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland |
EU/1/12/809 |
20.9.2017 |
|
18.9.2017 |
Bexsero |
GlaxoSmithKline Vaccines S.r.l. Via Fiorentina, 1, 53100 Siena, Italia |
EU/1/12/812 |
20.9.2017 |
|
18.9.2017 |
Blincyto |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/15/1047 |
20.9.2017 |
|
18.9.2017 |
Gazyvaro |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/14/937 |
20.9.2017 |
|
18.9.2017 |
Imatinib Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/12/808 |
20.9.2017 |
|
18.9.2017 |
Lumark |
IDB Holland B.V. Weverstraat 17, 5111 PV Baarle-Nassau, Nederland |
EU/1/15/1013 |
20.9.2017 |
|
18.9.2017 |
Lynparza |
AstraZeneca AB SE-151 85 Södertälje, Sverige |
EU/1/14/959 |
20.9.2017 |
|
18.9.2017 |
Lyxumia |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/12/811 |
20.9.2017 |
|
18.9.2017 |
Mozobil |
Genzyme Europe B.V. Gooimeer 10, NL-1411 DD Naarden, Nederland |
EU/1/09/537 |
20.9.2017 |
|
18.9.2017 |
NexoBrid |
MediWound Germany GmbH Eisenstr. 5, D-65428 Ruesselsheim, Deutschland |
EU/1/12/803 |
20.9.2017 |
|
18.9.2017 |
Ninlaro |
Takeda Pharma A/S Dybendal Alle 10, 2630 Taastrup, Danmark |
EU/1/16/1094 |
20.9.2017 |
|
18.9.2017 |
Nivestim |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom |
EU/1/10/631 |
20.9.2017 |
|
18.9.2017 |
NovoRapid |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/99/119 |
20.9.2017 |
|
18.9.2017 |
Opdivo |
Bristol-Myers Squibb Pharma EEIG Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, United Kingdom |
EU/1/15/1014 |
20.9.2017 |
|
18.9.2017 |
Oslif Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/586 |
20.9.2017 |
|
18.9.2017 |
Prolia |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/10/618 |
20.9.2017 |
|
18.9.2017 |
Retacrit |
Hospira UK Limited Horizon, Honey Lane, Hurley, Maidenhead, SL6 6RJ, United Kingdom |
EU/1/07/431 |
20.9.2017 |
|
18.9.2017 |
Revlimid |
Celgene Europe Limited 1 Longwalk Road, Stockley Park, Uxbridge, Middlesex UB11 1DB, United Kingdom |
EU/1/07/391 |
20.9.2017 |
|
18.9.2017 |
RoActemra |
Roche Registration Limited 6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, United Kingdom |
EU/1/08/492 |
20.9.2017 |
|
18.9.2017 |
RotaTeq |
MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France |
EU/1/06/348 |
20.9.2017 |
|
18.9.2017 |
Samsca |
Otsuka Pharmaceutical Europe Ltd. Gallions, Wexham Springs, Framewood Road, Wexham, SL3 6PJ, United Kingdom |
EU/1/09/539 |
21.9.2017 |
|
18.9.2017 |
Signifor |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/12/753 |
20.9.2017 |
|
18.9.2017 |
Xgeva |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/11/703 |
20.9.2017 |
|
18.9.2017 |
Zebinix |
Bial – Portela & Ca, SA À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal |
EU/1/09/514 |
28.7.2017 |
|
18.9.2017 |
Zebinix |
Bial – Portela & Ca, SA À Av. da Siderurgia Nacional 4745-457 S. Mamede do Coronado, Portugal |
EU/1/09/514 |
20.9.2017 |
|
18.9.2017 |
Zypadhera |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/08/479 |
20.9.2017 |
|
21.9.2017 |
Amyvid |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/12/805 |
25.9.2017 |
|
21.9.2017 |
EndolucinBeta |
ITG Isotope Technologies Garching GmbH Lichtenbergstr. 1, D-85748 Garching, Deutschland |
EU/1/16/1105 |
25.9.2017 |
|
21.9.2017 |
Iclusig |
Incyte Biosciences UK Ltd Riverbridge House, Guildford Road, Leatherhead, Surrey KT22 9AD, United Kingdom |
EU/1/13/839 |
25.9.2017 |
|
21.9.2017 |
Lartruvo |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/16/1143 |
25.9.2017 |
|
21.9.2017 |
Lenvima |
Eisai Europe Limited European Knowledge Centre, Mosquito Way, Hatfield, Herts AL10 9SN, United Kingdom |
EU/1/15/1002 |
25.9.2017 |
|
21.9.2017 |
Plenadren |
Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique/Montoyerstraat 47, 1000 Brussel, België |
EU/1/11/715 |
25.9.2017 |
|
21.9.2017 |
Relvar Ellipta |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/13/886 |
25.9.2017 |
|
21.9.2017 |
Revinty Ellipta |
Glaxo Group Ltd 980 Great West Road, Brentford, Middlesex, TW8 9GS, United Kingdom |
EU/1/14/929 |
25.9.2017 |
|
21.9.2017 |
Ryzodeg |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/12/806 |
25.9.2017 |
|
21.9.2017 |
Tresiba |
Novo Nordisk A/S Novo Allé, DK-2880 Bagsvaerd, Danmark |
EU/1/12/807 |
25.9.2017 |
|
21.9.2017 |
Xtandi |
Astellas Pharma Europe B.V. Sylviusweg 62, NL-2333 BE Leiden, Nederland |
EU/1/13/846 |
25.9.2017 |
|
21.9.2017 |
ZALTRAP |
Sanofi-Aventis groupe 54 rue La Boétie, F-75008 Paris, France |
EU/1/12/814 |
25.9.2017 |
|
26.9.2017 |
Hirobriz Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/594 |
28.9.2017 |
|
26.9.2017 |
Onbrez Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/09/593 |
28.9.2017 |
|
26.9.2017 |
Ristempa |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/15/996 |
28.9.2017 |
|
26.9.2017 |
Stayveer |
Marklas Nederland B.V. Beneluxlaan 2b, NL-3446 GR Woerden, Nederland |
EU/1/13/832 |
28.9.2017 |
|
26.9.2017 |
TachoSil |
Takeda Austria GmbH St.-Peter-Strasse 25, A-4020 Linz, Österreich |
EU/1/04/277 |
28.9.2017 |
|
26.9.2017 |
Tracleer |
Actelion Registration Ltd Chiswick Tower, 13th floor, 389 Chiswick High Road, London W4 4AL, United Kingdom |
EU/1/02/220 |
28.9.2017 |
|
26.9.2017 |
Xoterna Breezhaler |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/13/863 |
28.9.2017 |
|
28.9.2017 |
Neupro |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België |
EU/1/05/331 |
2.10.2017 |
|
28.9.2017 |
Revolade |
Novartis Europharm Limited Frimley Business Park, Camberley GU16 7SR, United Kingdom |
EU/1/10/612 |
29.9.2017 |
|
— |
Retragerea unei autorizații de introducere pe piață [articolul 13 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului] |
|
Data deciziei |
Denumirea medicamentului |
Titularul autorizației de introducere pe piață |
Numărul de înregistrare în Registrul comunitar |
Data notificării |
|
28.9.2017 |
Ristempa |
Amgen Europe B.V. Minervum 7061, NL-4817 ZK Breda, Nederland |
EU/1/15/996 |
2.10.2017 |
|
— |
Modificarea unei autorizații de introducere pe piață [articolul 38 din Regulamentul (CE) nr. 726/2004 al Parlamentului European și al Consiliului]: Acceptat |
|
Data deciziei |
Denumirea medicamentului |
Titularul autorizației de introducere pe piață |
Numărul de înregistrare în Registrul comunitar |
Data notificării |
|
7.9.2017 |
SevoFlo |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/02/035 |
11.9.2017 |
|
14.9.2017 |
Equilis Te |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/05/055 |
18.9.2017 |
|
14.9.2017 |
LETIFEND |
Laboratorios LETI, S.L.unipersonal C/Del Sol 5, Polígono Industrial Norte Tres Cantos, 28760 Madrid, España |
EU/2/16/195 |
18.9.2017 |
|
14.9.2017 |
Nobivac Myxo-RHD |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/11/132 |
18.9.2017 |
|
14.9.2017 |
Rheumocam |
Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland |
EU/2/07/078 |
19.9.2017 |
|
21.9.2017 |
Bovalto Ibraxion |
Merial 29 avenue Tony Garnier, F-69007 Lyon, France |
EU/2/99/017 |
25.9.2017 |
|
21.9.2017 |
Pirsue |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/00/027 |
25.9.2017 |
|
21.9.2017 |
Sevohale |
Chanelle Pharmaceuticals Manufacturing Limited Loughrea, Co. Galway, Ireland |
EU/2/16/196 |
25.9.2017 |
|
25.9.2017 |
Equilis Prequenza Te |
Intervet International B.V. Wim de Körverstraat 35, NL-5831 AN Boxmeer, Nederland |
EU/2/05/057 |
27.9.2017 |
|
25.9.2017 |
Metacam |
Boehringer Ingelheim Vetmedica GmbH D-55216 Ingelheim am Rhein, Deutschland |
EU/2/97/004 |
27.9.2017 |
|
28.9.2017 |
ProZinc |
Boehringer Ingelheim Vetmedica GmbH Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland |
EU/2/13/152 |
2.10.2017 |
|
28.9.2017 |
Versican Plus L4 |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/14/171 |
2.10.2017 |
|
28.9.2017 |
Versican Plus Pi |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/14/168 |
2.10.2017 |
|
28.9.2017 |
Versican Plus Pi/L4 |
Zoetis Belgium S.A. Rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/14/172 |
2.10.2017 |
Oricine este interesat să consulte raportul public de evaluare al medicamentului în cauză și deciziile aferente este invitat să contacteze:
|
European Medicines Agency |
|
30 Churchill Place |
|
Canary Wharf |
|
London E14 5EU |
|
United Kingdom |
(1) JO L 136, 30.4.2004, p. 1.