ISSN 1977-1045
Uradni list
Evropske unije
C 101
Slovenska izdaja
Informacije in objave
Letnik 63
27. marec 2020
|
ISSN 1977-1045 |
||
|
Uradni list Evropske unije |
C 101 |
|
|
|
||
|
Slovenska izdaja |
Informacije in objave |
Letnik 63 |
|
Vsebina |
Stran |
|
|
|
IV Informacije |
|
|
|
INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE |
|
|
|
Evropska komisija |
|
|
2020/C 101/01 |
|
SL |
|
IV Informacije
INFORMACIJE INSTITUCIJ, ORGANOV, URADOV IN AGENCIJ EVROPSKE UNIJE
Evropska komisija
|
27.3.2020 |
SL |
Uradni list Evropske unije |
C 101/1 |
Povzetek sklepov Evropske unije o dovoljenjih za promet z zdravili od 1. februarja 2020 do 29. februarja 2020
(Objavljeno v skladu s členom 13 ali členom 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta (1))
(2020/C 101/01)
— Izdaja dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena
|
Datum sprejetja sklepa |
Ime zdravila |
INN (mednarodno nelastniško ime) |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Farmacevtska oblika |
ATC (anatomsko terapevtska kemijska oznaka) |
Datum obvestila |
|
13.2.2020 |
Amsparity |
adalimumab |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/19/1415 |
Rztopina za injiciranje |
L04AB04 |
17.2.2020 |
|
13.2.2020 |
Azacitidine Accord |
Azacitidin |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |
EU/1/19/1413 |
prašek za suspenzijo za injiciranje |
L01BC07 |
17.2.2020 |
|
13.2.2020 |
Beovu |
brolucizumab |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/19/1417 |
Rztopina za injiciranje |
S01LA06 |
17.2.2020 |
|
13.2.2020 |
Deksmedetomidin Accord |
deksmedetomidin |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |
EU/1/19/1418 |
Koncentrat za raztopino za infundiranje |
N05CM18 |
17.2.2020 |
|
13.2.2020 |
Recarbrio |
imipenem/cilastatin/relebaktam |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/19/1420 |
Prašek za raztopino za infundiranje |
J01DH56 |
17.2.2020 |
— Sprememba dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena
|
Datum sprejetja sklepa |
Ime zdravila |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Datum obvestila |
|
4.2.2020 |
Ceprotin |
Takeda Manufacturing Austria AG Industriestraße 67, 1221 Wien, Österreich |
EU/1/01/190 |
6.2.2020 |
|
4.2.2020 |
CONTROLOC Control |
Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland |
EU/1/09/515 |
6.2.2020 |
|
4.2.2020 |
ellaOne |
Laboratoire HRA Pharma 200 avenue de Paris, 92320 Chatillon, France |
EU/1/09/522 |
6.2.2020 |
|
4.2.2020 |
Ivabradine Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |
EU/1/17/1190 |
6.2.2020 |
|
4.2.2020 |
Lacosamide Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |
EU/1/17/1230 |
6.2.2020 |
|
4.2.2020 |
LIFMIOR |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/16/1165 |
6.2.2020 |
|
4.2.2020 |
Mekinist |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/14/931 |
6.2.2020 |
|
4.2.2020 |
PANTOZOL Control |
Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland |
EU/1/09/517 |
6.2.2020 |
|
4.2.2020 |
Suboxone |
Indivior Europe Limited 27 Windsor Place, Dublin 2, Ireland |
EU/1/06/359 |
6.2.2020 |
|
4.2.2020 |
Ucedane |
Eurocept International B.V. Trapgans 5, 1244 RL Ankeveen, Nederland |
EU/1/17/1202 |
6.2.2020 |
|
4.2.2020 |
Ziagen |
ViiV Healthcare BV Huis ter Heideweg 62, 3705 LZ Zeist, Nederland |
EU/1/99/112 |
6.2.2020 |
|
4.2.2020 |
Zoely |
Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01 YE64, Ireland |
EU/1/11/690 |
6.2.2020 |
|
6.2.2020 |
Aranesp |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/01/185 |
10.2.2020 |
|
6.2.2020 |
Bronchitol |
Pharmaxis Europe Limited 108 Q House, Furze Road, Sandyford Dublin 18, D18AY29, Ireland |
EU/1/12/760 |
10.2.2020 |
|
6.2.2020 |
Fasenra |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/17/1252 |
10.2.2020 |
|
6.2.2020 |
Granpidam |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |
EU/1/16/1137 |
10.2.2020 |
|
6.2.2020 |
Jardiance |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/14/930 |
10.2.2020 |
|
6.2.2020 |
Neuraceq |
Life Radiopharma Berlin GmbH Max-Planck-Straße 4, 12489 Berlin, Deutschland |
EU/1/13/906 |
10.2.2020 |
|
6.2.2020 |
SOMAC Control |
Takeda GmbH Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland |
EU/1/09/516 |
10.2.2020 |
|
6.2.2020 |
Vokanamet |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/14/918 |
10.2.2020 |
|
10.2.2020 |
Inhixa |
Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland |
EU/1/16/1132 |
12.2.2020 |
|
11.2.2020 |
Alimta |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/04/290 |
13.2.2020 |
|
11.2.2020 |
ALPROLIX |
Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige |
EU/1/16/1098 |
13.2.2020 |
|
11.2.2020 |
Entecavir Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |
EU/1/17/1211 |
13.2.2020 |
|
11.2.2020 |
OCALIVA |
Intercept Pharma International Limited Ormond Building, 31 – 36 Ormond Quay Upper, Dublin 7, Ireland |
EU/1/16/1139 |
13.2.2020 |
|
11.2.2020 |
Orkambi |
Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland |
EU/1/15/1059 |
13.2.2020 |
|
11.2.2020 |
Pemetrexed Fresenius Kabi |
Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland |
EU/1/16/1115 |
13.2.2020 |
|
11.2.2020 |
Rebetol |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/99/107 |
13.2.2020 |
|
11.2.2020 |
Symkevi |
Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland |
EU/1/18/1306 |
13.2.2020 |
|
11.2.2020 |
Zeffix |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/99/114 |
13.2.2020 |
|
11.2.2020 |
Zevalin |
Ceft Biopharma s.r.o Trtinova 260/1 Cakovice, 196 00 Praha 9, Česká republika |
EU/1/03/264 |
13.2.2020 |
|
12.2.2020 |
Zoledronic acid Hospira |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/12/800 |
14.2.2020 |
|
13.2.2020 |
Aimovig |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/18/1293 |
17.2.2020 |
|
13.2.2020 |
Bosulif |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/13/818 |
17.2.2020 |
|
13.2.2020 |
Brineura |
BioMarin International Limited Shanbally, Ringaskiddy, County Cork, Ireland |
EU/1/17/1192 |
17.2.2020 |
|
13.2.2020 |
Dificlir |
Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland |
EU/1/11/733 |
17.2.2020 |
|
13.2.2020 |
Duloxetine Mylan |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/15/1010 |
17.2.2020 |
|
13.2.2020 |
Ebixa |
H. Lundbeck A/S Ottiliavej 9, 2500 Valby, Danmark |
EU/1/02/219 |
17.2.2020 |
|
13.2.2020 |
IBRANCE |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/16/1147 |
17.2.2020 |
|
13.2.2020 |
Mvasi |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland |
EU/1/17/1246 |
17.2.2020 |
|
13.2.2020 |
Quinsair |
Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/14/973 |
17.2.2020 |
|
13.2.2020 |
Sprycel |
Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |
EU/1/06/363 |
17.2.2020 |
|
13.2.2020 |
Tamiflu |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/02/222 |
17.2.2020 |
|
13.2.2020 |
Ventavis |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/03/255 |
17.2.2020 |
|
17.2.2020 |
Adempas |
Bayer AG D-51368 Leverkusen, Deutschland |
EU/1/13/907 |
19.2.2020 |
|
17.2.2020 |
Atripla |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/07/430 |
19.2.2020 |
|
17.2.2020 |
Eliquis |
Bristol-Myers Squibb/Pfizer EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland |
EU/1/11/691 |
19.2.2020 |
|
17.2.2020 |
Sifrol |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/97/050 |
19.2.2020 |
|
17.2.2020 |
Suliqua |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France |
EU/1/16/1157 |
19.2.2020 |
|
17.2.2020 |
Tacforius |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland |
EU/1/17/1244 |
2.3.2020 |
|
17.2.2020 |
Vyndaqel |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/11/717 |
19.2.2020 |
|
18.2.2020 |
Zypadhera |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/08/479 |
20.2.2020 |
|
21.2.2020 |
Cholib |
Mylan IRE Healthcare Ltd Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland |
EU/1/13/866 |
25.2.2020 |
|
21.2.2020 |
Cometriq |
Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France |
EU/1/13/890 |
25.2.2020 |
|
21.2.2020 |
Docetaksel Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |
EU/1/12/769 |
25.2.2020 |
|
21.2.2020 |
Eptifibatide Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |
EU/1/15/1065 |
25.2.2020 |
|
21.2.2020 |
Holoclar |
Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia |
EU/1/14/987 |
25.2.2020 |
|
21.2.2020 |
Imfinzi |
AstraZeneca AB 151 85 Södertälje, Sverige |
EU/1/18/1322 |
18.2.2020 |
|
21.2.2020 |
Lyrica |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/04/279 |
25.2.2020 |
|
21.2.2020 |
Mirapexin |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/97/051 |
25.2.2020 |
|
21.2.2020 |
Resolor |
Shire Pharmaceuticals Ireland Limited Block 2 & 3 Miesian Plaza, 50-58 Baggot Street Lower, D02 Y754 Dublin 2, Ireland |
EU/1/09/581 |
25.2.2020 |
|
21.2.2020 |
Trelegy Ellipta |
GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |
EU/1/17/1236 |
25.2.2020 |
|
21.2.2020 |
Vorikonazol Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |
EU/1/13/835 |
25.2.2020 |
|
21.2.2020 |
Zalasta |
Krka d. d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija |
EU/1/07/415 |
25.2.2020 |
|
21.2.2020 |
Zyprexa |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/96/022 |
25.2.2020 |
|
21.2.2020 |
Zyprexa Velotab |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/99/125 |
25.2.2020 |
|
24.2.2020 |
Docetaksel Kabi |
Fresenius Kabi Deutschland GmbH Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland |
EU/1/12/770 |
26.2.2020 |
|
24.2.2020 |
Lixiana |
Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland |
EU/1/15/993 |
26.2.2020 |
|
24.2.2020 |
Slenyto |
RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux, 75002 Paris, France |
EU/1/18/1318 |
26.2.2020 |
|
25.2.2020 |
Aripiprazole Mylan Pharma |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France |
EU/1/15/1005 |
27.2.2020 |
|
28.2.2020 |
Advagraf |
Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland |
EU/1/07/387 |
3.3.2020 |
|
28.2.2020 |
Bexsero |
GlaxoSmithKline Vaccines S.r.l. Via Fiorentina, 1, 53100 Siena, Italia |
EU/1/12/812 |
3.3.2020 |
|
28.2.2020 |
Cuprymina |
A.C.O.M. -ADVANCED CENTER ONCOLOGY MACERATA -S.R.L. Località Cavallino, 39 A/B 62010 Montecosaro (MC), Italia |
EU/1/12/784 |
3.3.2020 |
|
28.2.2020 |
Hetlioz |
Vanda Pharmaceuticals Germany GmbH Franzoesische Strasse 12, Mitte, Berlin 10117, Deutschland |
EU/1/15/1008 |
3.3.2020 |
|
28.2.2020 |
Januvia |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/07/383 |
3.3.2020 |
|
28.2.2020 |
Ledaga |
Helsinn Birex Pharmaceuticals Ltd. Damastown, Mulhuddart, Dublin 15, Ireland |
EU/1/16/1171 |
3.3.2020 |
|
28.2.2020 |
Modigraf |
Astellas Pharma Europe B.V. Sylviusweg 62, 2333 BE Leiden, Nederland |
EU/1/09/523 |
3.3.2020 |
|
28.2.2020 |
Pegfilgrastim Mundipharma |
Mundipharma Corporation (Ireland) Limited Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland |
EU/1/19/1409 |
3.3.2020 |
|
28.2.2020 |
Pemetrexed Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España |
EU/1/15/1071 |
3.3.2020 |
|
28.2.2020 |
Pemetrexed Lilly |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland |
EU/1/15/1034 |
3.3.2020 |
|
28.2.2020 |
Simponi |
Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland |
EU/1/09/546 |
3.3.2020 |
|
28.2.2020 |
Voncento |
CSL Behring GmbH Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland |
EU/1/13/857 |
3.3.2020 |
|
28.2.2020 |
Xerava |
Tetraphase Pharmaceuticals Ireland Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland |
EU/1/18/1312 |
3.3.2020 |
|
28.2.2020 |
Xeristar |
Esteve Pharmaceuticals S.A. Passeig de la Zona Franca, 109, 08038 Barcelona, España |
EU/1/04/297 |
3.3.2020 |
|
28.2.2020 |
Xolair |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/05/319 |
3.3.2020 |
|
28.2.2020 |
Zoledronic acid Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España |
EU/1/13/834 |
3.3.2020 |
|
28.2.2020 |
Zydelig |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland |
EU/1/14/938 |
3.3.2020 |
— Ukinitev dovoljenja za promet (člen 13 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)
|
Datum sprejetja sklepa |
Ime zdravila |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Datum obvestila |
|
11.2.2020 |
Picato |
LEO Laboratories Ltd 285 Cashel Road, Crumlin, Dublin 12, Ireland |
EU/1/12/796 |
13.2.2020 |
— Sprememba dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta): Odobrena
|
Datum sprejetja sklepa |
Ime zdravila |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Datum obvestila |
|
4.2.2020 |
Clevor |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi |
EU/2/17/222 |
6.2.2020 |
|
11.2.2020 |
Halagon |
Emdoka bvba J. Lijsenstraat 16, 2321 Hoogstraten, België |
EU/2/16/201 |
13.2.2020 |
|
11.2.2020 |
Meloxidyl |
Ceva Santé Animale 10 avenue de La Ballastière, 33500 Libourne, France |
EU/2/06/070 |
13.2.2020 |
|
11.2.2020 |
Oxyglobin |
OPK Biotech Netherlands BV Teleportboulevard 140, 1043 EJ Amsterdam, Nederland |
EU/2/99/015 |
14.2.2020 |
|
11.2.2020 |
Palladia |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/09/100 |
13.2.2020 |
|
17.2.2020 |
Zulvac 1 Bovis |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/11/130 |
19.2.2020 |
|
17.2.2020 |
Zulvac 1 Ovis |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/11/131 |
19.2.2020 |
|
18.2.2020 |
Emdocam |
Emdoka bvba J. Lijsenstraat 16, 2321 Hoogstraten, België |
EU/2/11/128 |
20.2.2020 |
|
18.2.2020 |
Zycortal |
Dechra Regulatory B.V. Handelsweg 25, 5531 AE Bladel, Nederland |
EU/2/15/189 |
20.2.2020 |
|
26.2.2020 |
Porcilis ColiClos |
Intervet International B.V. Wim de Körverstraat 35, 5831 AN Boxmeer, Nederland |
EU/2/12/141 |
28.2.2020 |
— Ukinitev dovoljenja za promet (člen 38 Uredbe (ES) št. 726/2004 Evropskega parlamenta in Sveta)
|
Datum sprejetja sklepa |
Ime zdravila |
Imetnik dovoljenja za promet |
Registracijska številka v registru Skupnosti |
Datum obvestila |
|
18.2.2020 |
Zulvac 1 Bovis |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/11/130 |
20.2.2020 |
|
18.2.2020 |
Zulvac 1 Ovis |
Zoetis Belgium S.A. rue Laid Burniat 1, 1348 Louvain-la-Neuve, Belgique |
EU/2/11/131 |
20.2.2020 |
Kdor želi dobiti vpogled v javno poročilo o oceni zadevnih zdravil ter o zadevnih sklepih o zdravilih, se lahko obrne na naslov:
|
European Medicines Agency |
|
Domenico Scarlattilaan 6 |
|
1083 HS Amsterdam |
|
NETHERLANDS |