| Data wydania decyzji |
Nazwa produktu leczniczego |
Posiadacz pozwolenia na dopuszczenie do obrotu |
Numer pozycji w rejestrze wspólnotowym |
Data notyfikacji |
| 5.1.2024 |
ALPROLIX |
Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige |
EU/1/16/1098 |
8.1.2024 |
| 5.1.2024 |
Bavencio |
Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland
|
EU/1/17/1214 |
9.1.2024 |
| 5.1.2024 |
Corbilta |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi
|
EU/1/13/859 |
9.1.2024 |
| 5.1.2024 |
Dectova |
GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |
EU/1/18/1349 |
10.1.2024 |
| 5.1.2024 |
Dexmedetomidine Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
EU/1/19/1418 |
9.1.2024 |
| 5.1.2024 |
Eylea |
Bayer AG D-51368 Leverkusen, Deutschland
|
EU/1/12/797 |
8.1.2024 |
| 5.1.2024 |
Ibandronic acid Accord |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6 a planta, 08039 Barcelona, España
|
EU/1/12/798 |
9.1.2024 |
| 5.1.2024 |
Jyseleca |
Galapagos NV Generaal De Wittelaan L11 A3, 2800 Mechelen, België
|
EU/1/20/1480 |
8.1.2024 |
| 5.1.2024 |
Libmyris |
STADA Arzneimittel AG Stadastraße 2-18, 61118 Bad Vilbel, Deutschland
|
EU/1/21/1590 |
9.1.2024 |
| 5.1.2024 |
LIVTENCITY |
Takeda Pharmaceuticals International AG Ireland Branch
Block 2 Miesian Plaza, 50-58 Baggot Street
Lower, Dublin 2, D02 HW68, Ireland
|
EU/1/22/1672 |
8.1.2024 |
| 5.1.2024 |
Mayzent |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/19/1414 |
8.1.2024 |
| 5.1.2024 |
Mirapexin |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/97/051 |
8.1.2024 |
| 5.1.2024 |
Mulpleo |
Shionogi B.V. Herengracht 464, 1017 CA, Amsterdam, Nederland
|
EU/1/18/1348 |
8.1.2024 |
| 5.1.2024 |
Nivestim |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/10/631 |
8.1.2024 |
| 5.1.2024 |
Pazenir |
ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland
|
EU/1/18/1317 |
9.1.2024 |
| 5.1.2024 |
Retsevmo |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
EU/1/20/1527 |
8.1.2024 |
| 5.1.2024 |
Sevelamer carbonate Winthrop |
Sanofi B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
EU/1/14/952 |
8.1.2024 |
| 5.1.2024 |
Sifrol |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/97/050 |
8.1.2024 |
| 5.1.2024 |
Skyrizi |
AbbVie Deutschland GmbH & Co. KG Knollstrasse, 67061 Ludwigshafen, Deutschland |
EU/1/19/1361 |
8.1.2024 |
| 5.1.2024 |
Stivarga |
Bayer AG D-51368 Leverkusen, Deutschland
|
EU/1/13/858 |
9.1.2024 |
| 5.1.2024 |
Suboxone |
Indivior Europe Limited 27 Windsor Place, Dublin 2, D02 DK44, Ireland
|
EU/1/06/359 |
9.1.2024 |
| 5.1.2024 |
Taltz |
Eli Lilly and Company (Ireland) Limited Dunderrow, Kinsale, Co. Cork, Ireland |
EU/1/15/1085 |
9.1.2024 |
| 5.1.2024 |
Talzenna |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/19/1377 |
8.1.2024 |
| 5.1.2024 |
Trecondi |
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland
|
EU/1/18/1351 |
8.1.2024 |
| 5.1.2024 |
Veltassa |
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 |
8.1.2024 |
| 9.1.2024 |
Lorviqua |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/19/1355 |
10.1.2024 |
| 11.1.2024 |
Grepid |
Pharmathen S.A. 6 Dervenakion, 15351 Pallini Attiki, Ελλάδα
|
EU/1/09/535 |
12.1.2024 |
| 11.1.2024 |
Olanzapine Glenmark |
Glenmark Arzneimittel GmbH Industriestr. 31, D - 82194 Gröbenzell, Deutschland
|
EU/1/09/587 |
18.1.2024 |
| 11.1.2024 |
Olanzapine Glenmark Europe |
Glenmark Arzneimittel GmbH Industriestr. 31, D - 82194 Gröbenzell, Deutschland
|
EU/1/09/588 |
18.1.2024 |
| 11.1.2024 |
Oncaspar |
Les Laboratoires Servier 50 rue Carnot, 92284 Suresnes Cedex, France
|
EU/1/15/1070 |
12.1.2024 |
| 11.1.2024 |
SIMBRINZA |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/14/933 |
12.1.2024 |
| 11.1.2024 |
Tavneos |
Vifor Fresenius Medical Care Renal Pharma France
100-101 terrasse Boieldieu, Tour Franklin La
Défense 8, 92042 Paris la Défense Cedex, France
|
EU/1/21/1605 |
12.1.2024 |
| 11.1.2024 |
Tecentriq |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/17/1220 |
12.1.2024 |
| 11.1.2024 |
Xenpozyme |
Sanofi B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
EU/1/22/1659 |
12.1.2024 |
| 12.1.2024 |
Clopidogrel TAD |
TAD Pharma GmbH Heinz-Lohmann-Straße 5, 27472 Cuxhaven, Deutschland
|
EU/1/09/555 |
17.1.2024 |
| 12.1.2024 |
Cresemba |
Basilea Pharmaceutica Deutschland GmbH Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland |
EU/1/15/1036 |
16.1.2024 |
| 12.1.2024 |
Elaprase |
Takeda Pharmaceuticals International AG Ireland Branch
Block 2, Miesian Plaza, 50-58 Baggot Street
Lower, Dublin 2, D02 HW68, Ireland
|
EU/1/06/365 |
15.1.2024 |
| 12.1.2024 |
Epivir |
ViiV Healthcare B.V. Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
|
EU/1/96/015 |
15.1.2024 |
| 12.1.2024 |
GHRYVELIN |
Atnahs Pharma Netherlands B.V. Copenhagen Towers, Ørestads Boulevard 108, 5. tv, DK-2300 København S, Danmark
|
EU/1/18/1337 |
15.1.2024 |
| 12.1.2024 |
Kisqali |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/17/1221 |
15.1.2024 |
| 12.1.2024 |
Metalyse |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/00/169 |
16.1.2024 |
| 12.1.2024 |
Nucala |
GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |
EU/1/15/1043 |
19.1.2024 |
| 12.1.2024 |
Ontozry |
Angelini Pharma S.p.A Viale Amelia 70, 00181 Rome, Italia
|
EU/1/21/1530 |
15.1.2024 |
| 12.1.2024 |
Steglujan |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/18/1266 |
17.1.2024 |
| 12.1.2024 |
Temodal |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/98/096 |
16.1.2024 |
| 12.1.2024 |
Tracleer |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/02/220 |
15.1.2024 |
| 23.1.2024 |
Lucentis |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/06/374 |
24.1.2024 |
| 25.1.2024 |
Aerinaze |
N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland
|
EU/1/07/399 |
26.1.2024 |
| 25.1.2024 |
Alkindi |
Diurnal Europe B.V. Van Heuven Goedhartlaan 935 A, 1181LD Amstelveen, Nederland
|
EU/1/17/1260 |
29.1.2024 |
| 25.1.2024 |
Azacitidine Betapharm |
betapharm Arzneimittel GmbH Kobelweg 95, 86156 Augsburg, Deutschland
|
EU/1/19/1416 |
29.1.2024 |
| 25.1.2024 |
Byfavo |
PAION Deutschland GmbH Heussstraße 25, 52078 Aachen, Deutschland
|
EU/1/20/1505 |
26.1.2024 |
| 25.1.2024 |
Cibinqo |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/21/1593 |
26.1.2024 |
| 25.1.2024 |
Darunavir Krka |
KRKA d d., Novo mesto Šmarješka cesta 6, 8501 Novo mesto, Slovenija
|
EU/1/17/1249 |
31.1.2024 |
| 25.1.2024 |
Darzalex |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/16/1101 |
26.1.2024 |
| 25.1.2024 |
Elebrato Ellipta |
GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |
EU/1/17/1237 |
26.1.2024 |
| 25.1.2024 |
Feraccru |
Norgine B.V. Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland
|
EU/1/15/1075 |
29.1.2024 |
| 25.1.2024 |
Filsuvez |
Amryt Pharmaceuticals DAC 45 Mespil Road, Dublin 4, Ireland |
EU/1/22/1652 |
26.1.2024 |
| 25.1.2024 |
HyQvia |
Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich
|
EU/1/13/840 |
26.1.2024 |
| 25.1.2024 |
Lenvima |
Eisai GmbH Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland
|
EU/1/15/1002 |
26.1.2024 |
| 25.1.2024 |
Levodopa/Carbido- pa/Entacapone Orion |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi
|
EU/1/11/706 |
28.1.2024 |
| 25.1.2024 |
Lutathera |
Advanced Accelerator Applications 8-10 Rue Henri Sainte-Claire Deville, 92500 Rueil-Malmaison, France |
EU/1/17/1226 |
30.1.2024 |
| 25.1.2024 |
Lynparza |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/14/959 |
26.1.2024 |
| 25.1.2024 |
Myocet liposomal |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland
|
EU/1/00/141 |
5.2.2024 |
| 25.1.2024 |
Neofordex |
THERAVIA 16 Rue Montrosier, 92200 Neuilly-sur-Seine, France
|
EU/1/15/1053 |
29.1.2024 |
| 25.1.2024 |
NovoSeven |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark
|
EU/1/96/006 |
29.1.2024 |
| 25.1.2024 |
Pregabalin Zentiva |
Zentiva, k.s. U Kabelovny 130, 102 37 Praha 10, Česká republika
|
EU/1/15/1021 |
27.1.2024 |
| 25.1.2024 |
Rapilysin |
Actavis Group PTC ehf. Dalshraun 1, 220 Hafnarfjöróur, Iceland
|
EU/1/96/018 |
26.1.2024 |
| 25.1.2024 |
Rebif |
Merck Europe B.V. Gustav Mahlerplein 102, lto Toren, 1082 MA Amsterdam, Nederland
|
EU/1/98/063 |
26.1.2024 |
| 25.1.2024 |
SANCUSO |
Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland
|
EU/1/12/766 |
6.2.2024 |
| 25.1.2024 |
Spherox |
CO.DON GmbH Deutscher Platz 5d, 04103 Leipzig, Deutschland
|
EU/1/17/1181 |
29.1.2024 |
| 25.1.2024 |
Stalevo |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi
|
EU/1/03/260 |
26.1.2024 |
| 25.1.2024 |
Stribild |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland
|
EU/1/13/830 |
26.1.2024 |
| 25.1.2024 |
Terrosa |
Gedeon Richter Plc. Gyömrői út 19-21, 1103 Budapest, Magyarország
|
EU/1/16/1159 |
5.2.2024 |
| 25.1.2024 |
Trajenta |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/11/707 |
26.1.2024 |
| 25.1.2024 |
Trelegy Ellipta |
GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |
EU/1/17/1236 |
26.1.2024 |
| 25.1.2024 |
Truvada |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland
|
EU/1/04/305 |
26.1.2024 |
| 25.1.2024 |
VeraSeal |
Instituto Grifols, S.A. Can Guasc, 2 - Parets del Vallès, 08150
Barcelona, Espana
|
EU/1/17/1239 |
29.1.2024 |
| 25.1.2024 |
ZALTRAP |
Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France
|
EU/1/12/814 |
26.1.2024 |
| 25.1.2024 |
Zyllt |
KRKA d d., Novo mesto Śmarjeska cesta 6, 8501 Novo mesto, Slovenija
|
EU/1/09/553 |
26.1.2024 |
| 26.1.2024 |
Cyramza |
Eli Lilly Nederland B.V. Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
EU/1/14/957 |
29.1.2024 |
| 26.1.2024 |
NULOJIX |
Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |
EU/1/11/694 |
29.1.2024 |
| 26.1.2024 |
ZINPLAVA |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/16/1156 |
29.1.2024 |
