Data wydania decyzji |
Nazwa produktu leczniczego |
Posiadacz pozwolenia na dopuszczenie do obrotu |
Numer pozycji w rejestrze wspólnotowym |
Data notyfikacji |
4.11.2024 |
Dupixent |
Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France |
EU/1/17/1229 |
5.11.2024 |
4.11.2024 |
Farydak |
pharmaand GmbH Taborstrasse 1, 1020 Wien, Österreich |
EU/1/15/1023 |
5.11.2024 |
4.11.2024 |
Hulio |
Biosimilar Collaborations Ireland Limited
Unit 35/36 Grange Parade, Baldoyle
Industrial Estate, Dublin 13, D13
R20R, DUBLIN, Ireland
|
EU/1/18/1319 |
6.11.2024 |
4.11.2024 |
Inaqovi |
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292, 1101 CT, Amsterdam, Nederland
|
EU/1/23/1756 |
6.11.2024 |
4.11.2024 |
Remicade |
Janssen Biologics B.V. Einsteinweg 101, 2333 CB Leiden, Nederland |
EU/1/99/116 |
5.11.2024 |
4.11.2024 |
Synjardy |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216
Ingelheim am Rhein, Deutschland
|
EU/1/15/1003 |
5.11.2024 |
4.11.2024 |
Vipdomet |
Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark
|
EU/1/13/843 |
5.11.2024 |
13.11.2024 |
Abevmy |
Biosimilar Collaborations Ireland Limited
Unit 35/36 Grange Parade, Baldoyle
Industrial Estate, Dublin 13, D13
R20R, DUBLIN, Ireland
|
EU/1/20/1515 |
20.11.2024 |
13.11.2024 |
Eladynos |
Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01
YE64, Ireland
|
EU/1/22/1706 |
14.11.2024 |
13.11.2024 |
ELREXFIO |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, Belgie |
EU/1/23/1770 |
15.11.2024 |
13.11.2024 |
MenQuadfi |
Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France |
EU/1/20/1483 |
14.11.2024 |
13.11.2024 |
Ruxience |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/20/1431 |
15.11.2024 |
13.11.2024 |
TAVLESSE |
Instituto Grifols, S.A. Can Guasc, 2, Parets del Vallès, 08150 Barcelona, Espana
|
EU/1/19/1405 |
18.11.2024 |
13.11.2024 |
Vaxelis |
MCM Vaccine B.V. Robert Boyleweg 4, 2333 CG Leiden, Nederland
|
EU/1/15/1079 |
14.11.2024 |
13.11.2024 |
Zynlonta |
Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige
|
EU/1/22/1695 |
14.11.2024 |
14.11.2024 |
Fingolimod Mylan |
Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |
EU/1/21/1573 |
15.11.2024 |
14.11.2024 |
Fulphila |
Biosimilar Collaborations Ireland Limited
Unit 35/36 Grange Parade, Baldoyle
Industrial Estate, Dublin 13, D13
R20R, DUBLIN, Ireland
|
EU/1/18/1329 |
27.11.2024 |
14.11.2024 |
Givlaari |
Alnylam Netherlands B.V. Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland
|
EU/1/20/1428 |
19.11.2024 |
14.11.2024 |
Incruse Ellipta |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/14/922 |
15.11.2024 |
14.11.2024 |
KIMMTRAK |
Immunocore Ireland Limited Unit 1 Sky Business Centres, Unit 21 Block Port Tunnel Business Park, Clonshaugh, Dublin 17, Dublin, D17 FY82, Ireland
|
EU/1/22/1630 |
18.11.2024 |
14.11.2024 |
Laventair Ellipta |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/14/899 |
15.11.2024 |
14.11.2024 |
Lenalidomide Mylan |
Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |
EU/1/20/1490 |
15.11.2024 |
14.11.2024 |
Lumeblue |
Cosmo Technologies Ltd Riverside II, Sir John
Rogerson's Quay, Dublin 2, Ireland
|
EU/1/20/1470 |
15.11.2024 |
14.11.2024 |
Lumykras |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda,
Nederland
|
EU/1/21/1603 |
15.11.2024 |
14.11.2024 |
Rolufta Ellipta |
GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business
Campus, Dublin 24, Ireland
|
EU/1/17/1174 |
15.11.2024 |
14.11.2024 |
Spevigo |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216
Ingelheim am Rhein, Deutschland
|
EU/1/22/1688 |
15.11.2024 |
14.11.2024 |
Sugammadex Mylan |
Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland |
EU/1/21/1583 |
15.11.2024 |
14.11.2024 |
Tarceva |
CHEPLAPHARM Registration GmbH Weiler Straße 5e, 79540 Lörrach, Deutschland
|
EU/1/05/311 |
20.11.2024 |
14.11.2024 |
Tecovirimat SIGA |
SIGA Technologies Netherlands B.V. Prinsenhil 29, Breda 4825 AX, Nederland
|
EU/1/21/1600 |
19.11.2024 |
14.11.2024 |
Uptravi |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/15/1083 |
15.11.2024 |
14.11.2024 |
Yescarta |
Kite Pharma EU B.V. Tufsteen 1, 2132 NT Hoofddorp, Nederland
|
EU/1/18/1299 |
15.11.2024 |
18.11.2024 |
Akynzeo |
Helsinn Birex Pharmaceuticals Ltd Damastown, Mulhuddart, Dublin 15, Ireland |
EU/1/15/1001 |
19.11.2024 |
18.11.2024 |
Apixaban Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de
Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
EU/1/20/1458 |
19.11.2024 |
18.11.2024 |
Cosentyx |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/14/980 |
19.11.2024 |
18.11.2024 |
Erleada |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/18/1342 |
19.11.2024 |
18.11.2024 |
Isturisa |
Recordati Rare Diseases Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France
|
EU/1/19/1407 |
19.11.2024 |
18.11.2024 |
Krazati |
Bristol Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland |
EU/1/23/1744 |
19.11.2024 |
18.11.2024 |
Lupkynis |
Otsuka Pharmaceutical Netherlands B.V.
Herikerbergweg 292, 1101 CT, Amsterdam, Nederland
|
EU/1/22/1678 |
19.11.2024 |
18.11.2024 |
Nevanac |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/07/433 |
19.11.2024 |
18.11.2024 |
Nilemdo |
Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland |
EU/1/20/1425 |
27.11.2024 |
18.11.2024 |
Nustendi |
Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland |
EU/1/20/1424 |
27.11.2024 |
18.11.2024 |
Orgovyx |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
EU/1/22/1642 |
19.11.2024 |
18.11.2024 |
Ozawade |
Bioprojet Pharma 9 rue Rameau, 75002 Paris, France
|
EU/1/21/1546 |
19.11.2024 |
18.11.2024 |
Praluent |
Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France |
EU/1/15/1031 |
19.11.2024 |
18.11.2024 |
Pylclari |
CURIUM PET France Biopole Clermont-Limagne, 3 rue Marie Curie, 63360 Saint-Beauzire, France
|
EU/1/23/1746 |
21.11.2024 |
18.11.2024 |
Simulect |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/98/084 |
19.11.2024 |
18.11.2024 |
Xolair |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/05/319 |
19.11.2024 |
19.11.2024 |
Victoza |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark
|
EU/1/09/529 |
26.11.2024 |
22.11.2024 |
Anoro Ellipta |
GlaxoSmithKline (Ireland) Limited 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland |
EU/1/14/898 |
25.11.2024 |
22.11.2024 |
Beovu |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/19/1417 |
25.11.2024 |
22.11.2024 |
Briviact |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België
|
EU/1/15/1073 |
26.11.2024 |
22.11.2024 |
Bylvay |
Ipsen Pharma 65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
|
EU/1/21/1566 |
29.11.2024 |
22.11.2024 |
Cablivi |
Ablynx N.V. Technologiepark 21, 9052 Zwijnaarde, België
|
EU/1/18/1305 |
25.11.2024 |
22.11.2024 |
Ebymect |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/15/1051 |
25.11.2024 |
22.11.2024 |
Rybelsus |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark |
EU/1/20/1430 |
26.11.2024 |
22.11.2024 |
SANCUSO |
Grünenthal GmbH Zieglerstraße 6, 52078, Aachen, Deutschland |
EU/1/12/766 |
28.11.2024 |
22.11.2024 |
Saxenda |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark
|
EU/1/15/992 |
26.11.2024 |
22.11.2024 |
Scintimun |
CIS bio international Boîte Postale 32, 91192 Gif-sur-
Yvette, France
|
EU/1/09/602 |
27.11.2024 |
22.11.2024 |
Vaxneuvance |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/21/1591 |
26.11.2024 |
22.11.2024 |
Yselty |
Theramex Ireland Limited 3rd Floor, Kilmore House, Park Lane, Spencer Dock, Dublin 1, D01
YE64, Ireland
|
EU/1/21/1606 |
25.11.2024 |
25.11.2024 |
Hepcludex |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland
|
EU/1/20/1446 |
26.11.2024 |
25.11.2024 |
Kevzara |
Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France |
EU/1/17/1196 |
26.11.2024 |
25.11.2024 |
Kisqali |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/17/1221 |
26.11.2024 |
25.11.2024 |
Menveo |
GSK Vaccines S.r.l. Via Fiorentina 1, 53100 Siena, Italia
|
EU/1/10/614 |
26.11.2024 |
25.11.2024 |
Orgalutran |
N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland
|
EU/1/00/130 |
27.11.2024 |
25.11.2024 |
Supemtek |
Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France |
EU/1/20/1484 |
28.11.2024 |
25.11.2024 |
Tevimbra |
BeiGene Ireland Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
|
EU/1/23/1758 |
26.11.2024 |
25.11.2024 |
Tigecycline Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
EU/1/19/1394 |
26.11.2024 |
28.11.2024 |
Azacitidine Betapharm |
betapharm Arzneimittel GmbH Kobelweg 95, 86156 Augsburg, Deutschland |
EU/1/19/1416 |
4.12.2024 |
28.11.2024 |
Besponsa |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/17/1200 |
29.11.2024 |
28.11.2024 |
Deferasirox Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
EU/1/19/1412 |
29.11.2024 |
28.11.2024 |
QUVIVIQ |
Idorsia Pharmaceuticals Deutschland GmbH Marie-Curie-Strasse 8, 79539 Lörrach, Deutschland |
EU/1/22/1638 |
3.12.2024 |
28.11.2024 |
Xigduo |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/13/900 |
29.11.2024 |
29.11.2024 |
Ameluz |
Biofrontera Bioscience GmbH Hemmelrather Weg 201, 51377 Leverkusen, Deutschland |
EU/1/11/740 |
4.12.2024 |
29.11.2024 |
Azacitidine Mylan |
Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle
Industrial Estate, Dublin 13, Ireland
|
EU/1/20/1426 |
2.12.2024 |
29.11.2024 |
Mircera |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/07/400 |
3.12.2024 |
29.11.2024 |
Tasigna |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/07/422 |
2.12.2024 |