Data wydania decyzji |
Nazwa produktu leczniczego |
Posiadacz pozwolenia na dopuszczenie do obrotu |
Numer pozycji w rejestrze wspólnotowym |
Data notyfikacji |
14.1.2021 |
Emselex |
zr pharma& GmbH Hietzinger Hauptstrasse 37, 1130 Wien, Österreich
|
EU/1/04/294 |
2.9.2021 |
22.1.2021 |
Vizamyl |
GE Healthcare AS Nycoveien 1, 0485, Oslo, Norge
|
EU/1/14/941 |
1.2.2021 |
25.5.2021 |
Januvia |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/07/383 |
18.1.2022 |
5.7.2021 |
Test INFAI Helicobacter |
INFAI GmbH Riehler Straße 36, 50668 Köln, Deutschland
|
EU/1/97/045 |
29.7.2021 |
9.7.2021 |
Vihuma |
Octapharma AB Lars Forssells gata 23, 112 75 Stockholm, Sverige
|
EU/1/16/1168 |
29.7.2021 |
16.7.2021 |
Atazanavir Mylan |
Mylan Pharmaceuticals Limited Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
EU/1/16/1091 |
31.8.2021 |
16.7.2021 |
Bondronat |
Atnahs Pharma Netherlands B.V. Copenhagen Towers, 0restads Boulevard 108, 5. tv, DK-2300 K0benhavn S, Danmark
|
EU/1/96/012 |
18.8.2021 |
16.7.2021 |
Glyxambi |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/16/1146 |
20.7.2021 |
16.7.2021 |
Mysildecard |
Viatris Limited Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
|
EU/1/16/1134 |
8.9.2021 |
23.7.2021 |
Fluad Tetra |
Seqirus Netherlands B.V. Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland
|
EU/1/20/1433 |
26.8.2021 |
23.7.2021 |
Flucelvax Tetra |
Seqirus Netherlands B.V. Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland
|
EU/1/18/1326 |
26.8.2021 |
23.7.2021 |
Galafold |
Amicus Therapeutics Europe Limited Block 1 Blanchardstown Corporate Park, Ballycoolen Road, Blanchardstown, Dublin, D15
AKK1, Ireland
|
EU/1/15/1082 |
28.7.2021 |
23.7.2021 |
Sildenafil Actavis |
Actavis Group PTC ehf. Reykjavikurvegi 76-78, 220 Hafnarfjöröur, Iceland
|
EU/1/09/595 |
16.8.2021 |
23.7.2021 |
Xeljanz |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, Belgie
|
EU/1/17/1178 |
27.7.2021 |
28.7.2021 |
Leflunomide ratiopharm |
ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland
|
EU/1/10/654 |
1.9.2021 |
12.8.2021 |
Lenalidomide My- lan |
Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
|
EU/1/20/1490 |
23.9.2021 |
18.8.2021 |
Hemlibra |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/18/1271 |
18.10.2021 |
18.8.2021 |
Palynziq |
BioMarin International Limited Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland
|
EU/1/19/1362 |
8.10.2021 |
20.8.2021 |
OBIZUR |
Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich
|
EU/1/15/1035 |
16.9.2021 |
15.9.2021 |
Velmetia |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/08/456 |
17.9.2021 |
16.9.2021 |
Luminity |
Lantheus EU Limited Rocktwist House, Block 1, Western Business
Park, Shannon, Co. Clare, V14 FW97, Ireland
|
EU/1/06/361 |
19.10.2021 |
29.9.2021 |
Abilify |
Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Nederland
|
EU/1/04/276 |
9.12.2021 |
29.9.2021 |
Acidum zolendro- nicum medac |
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland
|
EU/1/12/779 |
15.10.2021 |
29.9.2021 |
Cegfila |
Mundipharma Corporation (Ireland) Limited Millbank House, Arkle Road, Sandyford Industrial Estate, Dublin 18, Ireland |
EU/1/19/1409 |
13.10.2021 |
29.9.2021 |
Colobreathe |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland
|
EU/1/11/747 |
4.10.2021 |
29.9.2021 |
elmiron |
bene-Arzneimittel GmbH Herterichstraße 1-3, 81479 München, Deutschland
|
EU/1/17/1189 |
5.10.2021 |
29.9.2021 |
Praxbind |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/15/1056 |
5.10.2021 |
29.9.2021 |
VPRIV |
Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza, 50 - 58 Baggot Street
Lower, Dublin 2, Ireland
|
EU/1/10/646 |
30.9.2021 |
11.10.2021 |
Ibandronic acid Sandoz |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich
|
EU/1/11/685 |
8.11.2021 |
19.10.2021 |
Natpar |
Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza, 50 - 58 Baggot Street
Lower, Dublin 2, Ireland
|
EU/1/15/1078 |
20.10.2021 |
19.10.2021 |
Rivastigmine HEXAL |
Hexal AG Industriestraße 25, 83607 Holzkirchen, Deutschland
|
EU/1/09/589 |
26.11.2021 |
22.10.2021 |
Gencebok |
Gennisium Pharma Swen Parc de Vitrolles, Chemin de la Bastide Blanche, 13127 Vitrolles, France
|
EU/1/20/1465 |
9.11.2021 |
22.10.2021 |
Topotecan Hospira |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, Belgie
|
EU/1/10/633 |
25.10.2021 |
15.11.2021 |
Atazanavir Krka |
KRKA d d., Novo mesto Smarjeska cesta 6, 8501 Novo mesto, Slovenija
|
EU/1/19/1353 |
3.12.2021 |
15.11.2021 |
Pregabalin Pfizer |
Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland
|
EU/1/14/916 |
14.12.2021 |
15.11.2021 |
Revatio |
Upjohn EESV Rivium Westlaan 142, 2909 LD Capelle aan den IJssel, Nederland
|
EU/1/05/318 |
22.12.2021 |
15.11.2021 |
Ulunar Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/14/917 |
17.11.2021 |
18.11.2021 |
Ocaliva |
Intercept Pharma International Limited Ormond Building, 31 -36 Ormond Quay Upper, Dublin 7, Ireland |
EU/1/16/1139 |
1.12.2021 |
22.11.2021 |
Jylamvo |
Therakind (Europe) Limited Paramount Court, Corrig Road, Sandyford Business Park, Dublin 18, D18 R9C7, Ireland
|
EU/1/17/1172 |
22.12.2021 |
26.11.2021 |
Glustin |
Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark
|
EU/1/00/151 |
9.12.2021 |
26.11.2021 |
Lixiana |
Daiichi Sankyo Europe GmbH Zielstattstraße 48, 81379 München, Deutschland
|
EU/1/15/993 |
3.12.2021 |
9.12.2021 |
Imnovid |
Bristol Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland |
EU/1/13/850 |
7.1.2022 |
9.12.2021 |
Relistor |
Bausch Health Ireland Limited 3013 Lake Drive, Citywest Business Campus, Dublin 24, D24PPT3, Ireland
|
EU/1/08/463 |
14.12.2021 |
13.12.2021 |
AJOVY |
Teva GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland
|
EU/1/19/1358 |
15.12.2021 |
13.12.2021 |
Micardis |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/98/090 |
14.1.2022 |
13.12.2021 |
Onbrez Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/09/593 |
14.1.2022 |
16.12.2021 |
PREVYMIS |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/17/1245 |
17.1.2022 |
20.12.2021 |
Trazimera |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, Belgie
|
EU/1/18/1295 |
22.12.2021 |