Data wydania decyzji |
Nazwa produktu leczniczego |
Posiadacz pozwolenia na dopuszczenie do obrotu |
Numer pozycji w rejestrze wspólnotowym |
Data notyfikacji |
3.1.2022 |
COVID-19 Vaccine Janssen
|
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/20/1525 |
4.1.2022 |
6.1.2022 |
ADYNOVI |
Baxalta Innovations GmbH Industriestraße 67, 1221 Wien, Österreich
|
EU/1/17/1247 |
7.1.2022 |
6.1.2022 |
Arsenic trioxide Mylan |
Mylan Ireland Limited Unit 35/36 Grange Parade, Baldoyle Industrial
Estate, Dublin 13, Ireland
|
EU/1/20/1427 |
7.1.2022 |
6.1.2022 |
Bavencio |
Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland
|
EU/1/17/1214 |
10.1.2022 |
6.1.2022 |
Braftovi |
Pierre Fabre Médicament Les Cauquillous, 81500 Lavaur, France
|
EU/1/18/1314 |
10.1.2022 |
6.1.2022 |
CRYSVITA |
Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland
|
EU/1/17/1262 |
12.1.2022 |
6.1.2022 |
Darzalex |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/16/1101 |
7.1.2022 |
6.1.2022 |
Dupixent |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France
|
EU/1/17/1229 |
7.1.2022 |
6.1.2022 |
Elocta |
Swedish Orphan Biovitrum AB (publ) 112 76 Stockholm, Sverige |
EU/1/15/1046 |
10.1.2022 |
6.1.2022 |
Emtricitabine /Tenofovir disoproxil Krka d.d. |
KRKA d d., Novo mesto Smarjeska cesta 6, 8501 Novo mesto, Slovenija
|
EU/1/17/1182 |
12.1.2022 |
6.1.2022 |
Ferriprox |
Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia
|
EU/1/99/108 |
3.2.2022 |
6.1.2022 |
Inhixa |
Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland
|
EU/1/16/1132 |
18.1.2022 |
6.1.2022 |
Metalyse |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/00/169 |
11.1.2022 |
6.1.2022 |
Noxafil |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/05/320 |
10.1.2022 |
6.1.2022 |
Nuwiq |
Octapharma AB Lars Forssells gata 23, 112 75 Stockholm, Sverige
|
EU/1/14/936 |
10.1.2022 |
6.1.2022 |
Qarziba |
EUSA Pharma (Netherlands) B.V. Beechavenue 54, 1119PW Schiphol-Rijk, Nederland
|
EU/1/17/1191 |
12.1.2022 |
6.1.2022 |
Sirturo |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/13/901 |
7.1.2022 |
6.1.2022 |
Tecfidera |
Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
|
EU/1/13/837 |
7.1.2022 |
6.1.2022 |
Trydonis |
Chiesi Farmaceutici S.p.A. Via Palermo 26/A, 43122 Parma, Italia
|
EU/1/18/1274 |
7.1.2022 |
6.1.2022 |
Vfend |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/02/212 |
7.1.2022 |
6.1.2022 |
Zytiga |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/11/714 |
7.1.2022 |
7.1.2022 |
Epclusa |
Gilead Sciences Ireland UC Carrigtohill, County Cork, T45 DP77, Ireland
|
EU/1/16/1116 |
10.1.2022 |
7.1.2022 |
Kaftrio |
Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland |
EU/1/20/1468 |
10.1.2022 |
7.1.2022 |
Kalydeco |
Vertex Pharmaceuticals (Ireland) Limited 28-32 Pembroke Street Upper, Dublin 2, D02 EK84, Ireland |
EU/1/12/782 |
10.1.2022 |
7.1.2022 |
Ledaga |
Helsinn Birex Pharmaceuticals Ltd. Damastown, Mulhuddart, Dublin 15, Ireland
|
EU/1/16/1171 |
10.1.2022 |
7.1.2022 |
LIBTAYO |
Regeneron Ireland Designated Activity Company (DAC) One Warrington Place, Dublin 2, D02 HH27
Ireland
|
EU/1/19/1376 |
11.1.2022 |
7.1.2022 |
Rolufta Ellipta |
GlaxoSmithKline Trading Services Limited Riverwalk 12, Citywest Business Campus, Dublin 24, Ireland |
EU/1/17/1174 |
11.1.2022 |
7.1.2022 |
Yervoy |
Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |
EU/1/11/698 |
13.1.2022 |
11.1.2022 |
Caprelsa |
Genzyme Europe B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
EU/1/11/749 |
13.1.2022 |
11.1.2022 |
elmiron |
bene-Arzneimittel GmbH Herterichstraße 1-3, 81479 München, Deutschland
|
EU/1/17/1189 |
12.1.2022 |
11.1.2022 |
Ozempic |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark
|
EU/1/17/1251 |
12.1.2022 |
11.1.2022 |
Yargesa |
Piramal Critical Care B.V. Rouboslaan 32 (ground floor), 2252 TR, Voor- schoten, Nederland
|
EU/1/17/1176 |
13.1.2022 |
12.1.2022 |
Multaq |
Sanofi-Aventis groupe 54 rue La Boétie, 75008 Paris, France
|
EU/1/09/591 |
13.1.2022 |
12.1.2022 |
Ocaliva |
Intercept Pharma International Limited Ormond Building, 31 -36 Ormond Quay Upper, Dublin 7, Ireland |
EU/1/16/1139 |
13.1.2022 |
14.1.2022 |
COVID-19 Vaccine Janssen
|
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/20/1525 |
14.1.2022 |
14.1.2022 |
Lonquex |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland
|
EU/1/13/856 |
18.1.2022 |
14.1.2022 |
Vaxzevria |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/21/1529 |
14.1.2022 |
20.1.2022 |
Abecma |
Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |
EU/1/21/1539 |
21.1.2022 |
20.1.2022 |
Cosentyx |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/14/980 |
24.1.2022 |
20.1.2022 |
Inhixa |
Techdow Pharma Netherlands B.V. Strawinskylaan 1143, Toren C-11, 1077 XX Amsterdam, Nederland
|
EU/1/16/1132 |
21.1.2022 |
20.1.2022 |
Lumigan |
Allergan Pharmaceuticals Ireland Castlebar Road, Westport, County Mayo, Ireland
|
EU/1/02/205 |
25.1.2022 |
20.1.2022 |
Plenadren |
Takeda Pharmaceuticals International AG Ireland Branch
Block 3 Miesian Plaza, 50 - 58 Baggot Street
Lower, Dublin 2, Ireland
|
EU/1/11/715 |
24.1.2022 |
20.1.2022 |
Pradaxa |
Boehringer Ingelheim International GmbH Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland |
EU/1/08/442 |
24.1.2022 |
20.1.2022 |
Yescarta |
Kite Pharma EU B.V. Tufsteen 1, 2132 NT Hoofddorp, Nederland
|
EU/1/18/1299 |
21.1.2022 |
24.1.2022 |
Bridion |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/08/466 |
25.1.2022 |
24.1.2022 |
Cinryze |
Shire Services BVBA rue Montoyer 47, 1000 Bruxelles, Belgique / Montoyerstraat 47, 1000 Brussel, België
|
EU/1/11/688 |
25.1.2022 |
24.1.2022 |
Circadin |
RAD Neurim Pharmaceuticals EEC SARL 4 rue de Marivaux, 75002 Paris, France |
EU/1/07/392 |
26.1.2022 |
24.1.2022 |
Comirnaty |
BioNTech Manufacturing GmbH An der Goldgrube 12, 55131 Mainz, Deutschland
|
EU/1/20/1528 |
24.1.2022 |
24.1.2022 |
Exjade |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/06/356 |
25.1.2022 |
24.1.2022 |
Fotivda |
EUSA Pharma (Netherlands) B.V. Beechavenue 54, 1119PW Schiphol-Rijk, Nederland
|
EU/1/17/1215 |
28.1.2022 |
24.1.2022 |
Javlor |
PIERRE FABRE MEDICAMENT Les Cauquillous, 81500 Lavaur, France
|
EU/1/09/550 |
25.1.2022 |
24.1.2022 |
KEYTRUDA |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/15/1024 |
25.1.2022 |
24.1.2022 |
Kymriah |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/18/1297 |
25.1.2022 |
24.1.2022 |
Lokelma |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/17/1173 |
25.1.2022 |
24.1.2022 |
NUCEIVA |
Evolus Pharma B.V. Apollolaan 151, 1077 AR Amsterdam, Nederland
|
EU/1/19/1364 |
7.2.2022 |
24.1.2022 |
Oslif Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/09/586 |
25.1.2022 |
24.1.2022 |
Pregabalin Sandoz GmbH |
Sandoz GmbH Biochemiestrasse 10, 6250 Kundl, Österreich
|
EU/1/15/1012 |
25.1.2022 |
24.1.2022 |
Tecartus |
Kite Pharma EU B.V. Tufsteen 1, 2132 NT Hoofddorp, Nederland
|
EU/1/20/1492 |
25.1.2022 |
24.1.2022 |
Teysuno |
Nordic Group B.V. Siriusdreef 41, 2132 WT Hoofddorp, Nederland
|
EU/1/11/669 |
26.1.2022 |
24.1.2022 |
Ultibro Breezhaler |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/13/862 |
25.1.2022 |
24.1.2022 |
Vizarsin |
KRKA d d., Novo mesto Smarjeska cesta 6, 8501 Novo mesto, Slovenija
|
EU/1/09/551 |
26.1.2022 |
24.1.2022 |
Zynquista |
Guidehouse Germany GmbH Albrechtstrasse 10c, 10117 Berlin, Deutschland
|
EU/1/19/1363 |
29.1.2022 |
25.1.2022 |
Actraphane |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark
|
EU/1/02/229 |
31.1.2022 |
25.1.2022 |
Actrapid |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark
|
EU/1/02/230 |
26.1.2022 |
25.1.2022 |
Fasenra |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/17/1252 |
27.1.2022 |
25.1.2022 |
Lantus |
Sanofi-Aventis Deutschland GmbH D-65926 Frankfurt am Main, Deutschland
|
EU/1/00/134 |
26.1.2022 |
25.1.2022 |
Prolia |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland
|
EU/1/10/618 |
27.1.2022 |
25.1.2022 |
Sixmo |
L. Molteni & C. dei F.lli Alitti Soc.Es.S.p.A Strada Statale 67, 50018 Scandicci (Firenze), Italia |
EU/1/19/1369 |
27.1.2022 |
27.1.2022 |
Arsenic trioxide medac |
medac Gesellschaft für klinische Spezialpräparate mbH Theaterstraße 6, 22880 Wedel, Deutschland
|
EU/1/20/1475 |
31.1.2022 |
27.1.2022 |
Desloratadine ratiopharm |
ratiopharm GmbH Graf-Arco-Straße 3, 89079 Ulm, Deutschland
|
EU/1/11/746 |
30.1.2022 |
27.1.2022 |
Gilenya |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
EU/1/11/677 |
28.1.2022 |
27.1.2022 |
Libmeldy |
Orchard Therapeutics (Netherlands) B.V. Prins Bernhardplein 200, 1097 JB, Noord-Hol- land, Amsterdam, Nederland
|
EU/1/20/1493 |
31.1.2022 |
27.1.2022 |
Lorviqua |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/19/1355 |
28.1.2022 |
27.1.2022 |
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 |
28.1.2022 |
27.1.2022 |
Staquis |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
EU/1/19/1421 |
28.1.2022 |
27.1.2022 |
Telmisartan Teva Pharma |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland
|
EU/1/11/719 |
28.1.2022 |
27.1.2022 |
Zinforo |
Pfizer Ireland Pharmaceuticals Operations Support Group, Ringaskiddy, County Cork, Ireland
|
EU/1/12/785 |
28.1.2022 |
27.1.2022 |
Zonegran |
Amdipharm Limited 3 Burlington Road, Dublin 4, D04 RD68, IRELAND
|
EU/1/04/307 |
28.1.2022 |
31.1.2022 |
Avastin |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland |
EU/1/04/300 |
1.2.2022 |
31.1.2022 |
Benepali |
Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland
|
EU/1/15/1074 |
4.2.2022 |
31.1.2022 |
Besremi |
AOP Orphan Pharmaceuticals GmbH, Leopold-Ungar-Platz 2, 1190 Wien, Österreich |
EU/1/18/1352 |
2.2.2022 |
31.1.2022 |
Entyvio |
Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark
|
EU/1/14/923 |
2.2.2022 |
31.1.2022 |
Ervebo |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland
|
EU/1/19/1392 |
2.2.2022 |
31.1.2022 |
Fareston |
Orion Corporation Orionintie 1, 02200 Espoo, Suomi
|
EU/1/96/004 |
1.2.2022 |
31.1.2022 |
Juluca |
ViiV Healthcare B.V. Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
|
EU/1/18/1282 |
1.2.2022 |
31.1.2022 |
Luveris |
Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland
|
EU/1/00/155 |
2.2.2022 |
31.1.2022 |
Mulpleo |
Shionogi B.V. Kingsfordweg 151, 1043 GR Amsterdam, Nederland
|
EU/1/18/1348 |
1.2.2022 |
31.1.2022 |
Pemetrexed Hospi- ra |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, Belgie
|
EU/1/15/1057 |
1.2.2022 |
31.1.2022 |
Rhokiinsa |
Santen Oy Niittyhaankatu 20, 33720 Tampere, Suomi
|
EU/1/19/1400 |
2.2.2022 |
31.1.2022 |
Spinraza |
Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
|
EU/1/17/1188 |
1.2.2022 |
31.1.2022 |
Tivicay |
ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland
|
EU/1/13/892 |
1.2.2022 |