Data wydania decyzji |
Nazwa produktu leczniczego |
Posiadacz pozwolenia na dopuszczenie do obrotu |
Numer pozycji w rejestrze wspólnotowym |
Data notyfikacji |
2.8.2021 |
CANCIDAS |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/01/196 |
31.8.2021 |
2.8.2021 |
Emadine |
Immedica Pharma AB SE-113 29 Stockholm, Sverige
|
EU/1/98/095 |
5.8.2021 |
2.8.2021 |
Hepcludex |
MYR GmbH Hessenring 89, 61348 Bad Homburg, Deutschland
|
EU/1/20/1446 |
9.8.2021 |
2.8.2021 |
Tolura |
KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija
|
EU/1/10/632 |
16.8.2021 |
5.8.2021 |
Forxiga |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/12/795 |
6.8.2021 |
12.8.2021 |
AMGEVITA |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland
|
EU/1/16/1164 |
13.8.2021 |
12.8.2021 |
Azacitidine Mylan |
Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial
Estate, Dublin 13, Ireland
|
EU/1/20/1426 |
13.8.2021 |
12.8.2021 |
Combivir |
ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland
|
EU/1/98/058 |
13.8.2021 |
12.8.2021 |
Cometriq |
Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
|
EU/1/13/890 |
13.8.2021 |
12.8.2021 |
Imatinib Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
EU/1/13/845 |
13.8.2021 |
12.8.2021 |
Pegasys |
zr pharma& GmbH Hietzinger Hauptstrasse 37, 1130 Wien, Österreich
|
EU/1/02/221 |
30.8.2021 |
12.8.2021 |
Taltz |
Eli Lilly and Company (Ireland) Limited Dunderrow, Kinsale, Co. Cork, Ireland |
EU/1/15/1085 |
30.8.2021 |
18.8.2021 |
Fiasp |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark
|
EU/1/16/1160 |
19.8.2021 |
18.8.2021 |
Givlaari |
Alnylam Netherlands B.V. Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland
|
EU/1/20/1428 |
19.8.2021 |
18.8.2021 |
Noxafil |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/05/320 |
1.9.2021 |
18.8.2021 |
Ofev |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/14/979 |
19.8.2021 |
18.8.2021 |
Ogivri |
Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
|
EU/1/18/1341 |
31.8.2021 |
18.8.2021 |
Rybelsus |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark
|
EU/1/20/1430 |
19.8.2021 |
18.8.2021 |
Rydapt |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/17/1218 |
19.8.2021 |
18.8.2021 |
Suboxone |
Indivior Europe Limited 27 Windsor Place, Dublin 2, D02 DK44, Ireland
|
EU/1/06/359 |
19.8.2021 |
18.8.2021 |
TAVLESSE |
Instituto Grifols, S.A. Can Guasc, 2, Parets del Vallès, 08150 Barcelona, Espaňa
|
EU/1/19/1405 |
31.8.2021 |
18.8.2021 |
Truxima |
Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
|
EU/1/16/1167 |
19.8.2021 |
18.8.2021 |
VITRAKVI |
Bayer AG D-51368 Leverkusen, Deutschland
|
EU/1/19/1385 |
20.8.2021 |
18.8.2021 |
Voriconazole Hik- ma |
Hikma Farmacêutica (Portugal), S.A. Estrada do Rio da Mó n.o 8, 8A e 8B, Fervença, 2705-906 Terrugem SNT, Portugal
|
EU/1/15/1004 |
23.8.2021 |
18.8.2021 |
Xeljanz |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/17/1178 |
19.8.2021 |
18.8.2021 |
Zostavax |
MSD VACCINS 162 avenue Jean Jaurès, 69007 Lyon, France
|
EU/1/06/341 |
19.8.2021 |
20.8.2021 |
AFSTYLA |
CSL Behring GmbH Emil-von-Behring-StraEe 76, 35041 Marburg, Deutschland |
EU/1/16/1158 |
24.8.2021 |
20.8.2021 |
Apidra |
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland |
EU/1/04/285 |
23.8.2021 |
20.8.2021 |
Blitzima |
Celltrion Healthcare Hungary Kft. Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
|
EU/1/17/1205 |
23.8.2021 |
20.8.2021 |
Caelyx pegylated liposomal |
Baxter Holding B.V. Kobaltweg 49, 3542 CE Utrecht, Nederland
|
EU/1/96/011 |
23.8.2021 |
20.8.2021 |
Copiktra |
Secura Bio Limited 32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland
|
EU/1/21/1542 |
23.8.2021 |
20.8.2021 |
Dovato |
ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland
|
EU/1/19/1370 |
23.8.2021 |
20.8.2021 |
Evra |
Gedeon Richter Plc. Gyömroi ut 19-21, 1103 Budapest, Magyaror- szag
|
EU/1/02/223 |
23.8.2021 |
20.8.2021 |
Imatinib Actavis |
Actavis Group PTC ehf. Reykjavikurvegi 76-78, 220 Hafnarfjöröur, Iceland
|
EU/1/13/825 |
23.8.2021 |
20.8.2021 |
IMBRUVICA |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, Belgie |
EU/1/14/945 |
23.8.2021 |
20.8.2021 |
Insuman |
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland |
EU/1/97/030 |
23.8.2021 |
20.8.2021 |
Kivexa |
ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland
|
EU/1/04/298 |
23.8.2021 |
20.8.2021 |
Rinvoq |
AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland |
EU/1/19/1404 |
23.8.2021 |
20.8.2021 |
Rixathon |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich
|
EU/1/17/1185 |
23.8.2021 |
20.8.2021 |
Ruxience |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, Belgie
|
EU/1/20/1431 |
23.8.2021 |
20.8.2021 |
Tecentriq |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/17/1220 |
24.8.2021 |
20.8.2021 |
Trizivir |
ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland
|
EU/1/00/156 |
23.8.2021 |
20.8.2021 |
Veklury |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland
|
EU/1/20/1459 |
26.8.2021 |
26.8.2021 |
Adakveo |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/20/1476 |
27.8.2021 |
26.8.2021 |
Combivir |
ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland
|
EU/1/98/058 |
27.8.2021 |
26.8.2021 |
Efficib |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/08/457 |
27.8.2021 |
26.8.2021 |
Inhixa |
Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland
|
EU/1/16/1132 |
27.8.2021 |
26.8.2021 |
Mabthera |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/98/067 |
27.8.2021 |
26.8.2021 |
Mekinist |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/14/931 |
27.8.2021 |
26.8.2021 |
Riximyo |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich
|
EU/1/17/1184 |
30.8.2021 |
26.8.2021 |
SonoVue |
Bracco International B.V. Strawinskylaan 3051, 1077 ZX Amsterdam, Nederland
|
EU/1/01/177 |
30.8.2021 |
26.8.2021 |
Stivarga |
Bayer AG D-51368 Leverkusen, Deutschland
|
EU/1/13/858 |
2.9.2021 |
26.8.2021 |
Tafinlar |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/13/865 |
27.8.2021 |
26.8.2021 |
Tenofovir disopro- xil Mylan |
Mylan S.A.S. 117 allée des Parcs, 69800 Saint Priest, France
|
EU/1/16/1129 |
27.8.2021 |
26.8.2021 |
Xarelto |
Bayer AG D-51368 Leverkusen, Deutschland
|
EU/1/08/472 |
27.8.2021 |
27.8.2021 |
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 |
30.8.2021 |
27.8.2021 |
Ristaben |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/10/621 |
7.9.2021 |