| Data wydania decyzji |
Nazwa produktu leczniczego |
Posiadacz pozwolenia na dopuszczenie do obrotu |
Numer pozycji w rejestrze wspólnotowym |
Data notyfikacji |
| 01.03.2024 |
Evicel |
Omrix Biopharmaceuticals N.V. Leonardo Da Vincilaan 15, 1831 Diegem, België |
EU/1/08/473 |
06.03.2024 |
| 01.03.2024 |
Nityr |
Cycle Pharmaceuticals (Europe) Ltd 70 Sir John Rogerson's Quay, Dublin 2, D02 R296, Ireland |
EU/1/18/1290 |
04.03.2024 |
| 01.03.2024 |
Pepaxti |
Oncopeptides AB (publ) Luntmakargatan 46, 111 37
Stockholm, Sverige
|
EU/1/22/1669 |
04.03.2024 |
| 01.03.2024 |
Zercepac |
Accord Healthcare S.L.U. World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
EU/1/20/1456 |
04.03.2024 |
| 01.03.2024 |
Zoledronic acid Actavis |
Actavis Group PTC ehf. Dalshraun 1, 220 Hafnarfjöröur, Iceland
|
EU/1/12/759 |
04.03.2024 |
| 11.03.2024 |
CARVYKTI |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/22/1648 |
13.03.2024 |
| 11.03.2024 |
Ecansya |
KRKA d d., Novo mesto Smarjeska cesta 6, 8501 Novo mesto, Slovenija |
EU/1/12/763 |
12.03.2024 |
| 11.03.2024 |
Ondexxya |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/18/1345 |
12.03.2024 |
| 11.03.2024 |
Prevenar 20 |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/21/1612 |
12.03.2024 |
| 11.03.2024 |
Striascan |
CIS bio international RN 306 - Saclay, B.P. 32, F-91192
Gif-sur-Yvette Cedex, France
|
EU/1/19/1372 |
12.03.2024 |
| 11.03.2024 |
Upstaza |
PTC Therapeutics International Limited 70 Sir John Rogerson's Quay, Dublin 2, Ireland
|
EU/1/22/1653 |
12.03.2024 |
| 11.03.2024 |
Waylivra |
Akcea Therapeutics Ireland Ltd St. James House, 72 Adelaide Road, Dublin 2, D02 Y017, Ireland |
EU/1/19/1360 |
12.03.2024 |
| 14.03.2024 |
Cervarix |
GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique |
EU/1/07/419 |
15.03.2024 |
| 14.03.2024 |
Epysqli |
Samsung Bioepis NL B.V. Olof Palmestraat 10, 2616 LR Delft, Nederland
|
EU/1/23/1735 |
19.03.2024 |
| 14.03.2024 |
Firazyr |
Takeda Pharmaceuticals International AG Ireland Branch Block 2, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland
|
EU/1/08/461 |
15.03.2024 |
| 14.03.2024 |
Inbrija |
Acorda Therapeutics Ireland Limited 10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
|
EU/1/19/1390 |
21.03.2024 |
| 14.03.2024 |
Infanrix hexa |
GlaxoSmithKline Biologicals S.A. rue de l'Institut 89, 1330 Rixensart, Belgique |
EU/1/00/152 |
04.04.2024 |
| 14.03.2024 |
JEVTANA |
Sanofi Winthrop Industrie 82 avenue Raspail, 94250 Gentilly, France |
EU/1/11/676 |
15.03.2024 |
| 14.03.2024 |
Mozobil |
Sanofi B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
EU/1/09/537 |
15.03.2024 |
| 14.03.2024 |
Tarceva |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Gren- zach-Wyhlen, Deutschland |
EU/1/05/311 |
15.03.2024 |
| 14.03.2024 |
Yargesa |
Piramal Critical Care B.V. Rouboslaan 32 (ground floor), 2252 TR, Voorschoten, Nederland |
EU/1/17/1176 |
19.03.2024 |
| 14.03.2024 |
Zabdeno |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/20/1444 |
15.03.2024 |
| 18.03.2024 |
Mekinist |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/14/931 |
20.03.2024 |
| 19.03.2024 |
Braftovi |
Pierre Fabre Médicament Les Cauquillous, 81500 Lavaur, France |
EU/1/18/1314 |
21.03.2024 |
| 19.03.2024 |
Fintepla |
UCB Pharma S.A. Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België
|
EU/1/20/1491 |
21.03.2024 |
| 19.03.2024 |
Ninlaro |
Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark
|
EU/1/16/1094 |
20.03.2024 |
| 19.03.2024 |
Plegridy |
Biogen Netherlands B.V. Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
|
EU/1/14/934 |
20.03.2024 |
| 19.03.2024 |
Qarziba |
Recordati Netherlands B.V. Beechavenue 54, 1119PW Schip- hol-Rijk, Nederland
|
EU/1/17/1191 |
22.03.2024 |
| 19.03.2024 |
Xromi |
Nova Laboratories Ireland Limited 3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland |
EU/1/19/1366 |
20.03.2024 |
| 21.03.2024 |
Aldurazyme |
Sanofi B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
EU/1/03/253 |
22.03.2024 |
| 21.03.2024 |
Ambrisentan Mylan |
Mylan Pharmaceuticals Limited Damastown Industrial Park, Mul- huddart, Dublin 15, DUBLIN, Ireland |
EU/1/19/1368 |
25.03.2024 |
| 21.03.2024 |
BIMERVAX |
Hipra Human Health, S.L.U. Avda. la Selva, 135, 17170 Amer (Girona), España
|
EU/1/22/1709 |
22.03.2024 |
| 21.03.2024 |
Celdoxome pegyla- ted liposomal |
Baxter Holding B.V. Kobaltweg 49, 3542 CE Utrecht, Nederland
|
EU/1/22/1666 |
02.04.2024 |
| 21.03.2024 |
Cibinqo |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/21/1593 |
22.03.2024 |
| 21.03.2024 |
Clopidogrel ratiopharm |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland
|
EU/1/14/975 |
26.03.2024 |
| 21.03.2024 |
Dovato |
ViiV Healthcare BV Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland
|
EU/1/19/1370 |
22.03.2024 |
| 21.03.2024 |
Enjaymo |
Sanofi B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
EU/1/22/1687 |
27.03.2024 |
| 21.03.2024 |
Giapreza |
PAION Deutschland GmbH HeussstraEe 25, 52078 Aachen, Deutschland |
EU/1/19/1384 |
22.03.2024 |
| 21.03.2024 |
Lunsumio |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Gren- zach-Wyhlen, Deutschland |
EU/1/22/1649 |
22.03.2024 |
| 21.03.2024 |
Mektovi |
Pierre Fabre Médicament Les Cauquillous, 81500 Lavaur, France |
EU/1/18/1315 |
22.03.2024 |
| 21.03.2024 |
Nemdatine |
Actavis Group PTC ehf. Dalshraun 1, 220 Hafnarfjöröur, Iceland
|
EU/1/13/824 |
22.03.2024 |
| 21.03.2024 |
Nexviadyme |
Sanofi B.V. Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
EU/1/21/1579 |
27.03.2024 |
| 21.03.2024 |
Ozempic |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark
|
EU/1/17/1251 |
22.03.2024 |
| 21.03.2024 |
Spikevax |
MODERNA BIOTECH SPAIN, S.L. |
EU/1/20/1507 |
25.03.2024 |
| 21.03.2024 |
Tepadina |
ADIENNE S.r.l.S.U. Via Galileo Galilei 19, 20867 Caponago (MB), Italia
|
EU/1/10/622 |
25.03.2024 |
| 21.03.2024 |
Uplizna |
Horizon Therapeutics Ireland DAC 70 St. Stephen's Green, Dublin 2, D02 E2X4, Ireland |
EU/1/21/1602 |
22.03.2024 |
| 21.03.2024 |
Wegovy |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark
|
EU/1/21/1608 |
22.03.2024 |
| 25.03.2024 |
ABILIFY MAIN- TENA |
Otsuka Pharmaceutical Netherlands B.V. Herikerbergweg 292, 1101 CT, Amsterdam, Nederland
|
EU/1/13/882 |
05.04.2024 |
| 25.03.2024 |
Aerinaze |
N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland
|
EU/1/07/399 |
26.03.2024 |
| 25.03.2024 |
CellCept |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Gren- zach-Wyhlen, Deutschland |
EU/1/96/005 |
26.03.2024 |
| 25.03.2024 |
GAVRETO |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Gren- zach-Wyhlen, Deutschland |
EU/1/21/1555 |
26.03.2024 |
| 25.03.2024 |
KEYTRUDA |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/15/1024 |
02.04.2024 |
| 25.03.2024 |
Mycophenolate mofetil Teva |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland
|
EU/1/07/439 |
26.03.2024 |
| 25.03.2024 |
Myfenax |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland
|
EU/1/07/438 |
26.03.2024 |
| 25.03.2024 |
OPDIVO |
Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |
EU/1/15/1014 |
26.03.2024 |
| 25.03.2024 |
PecFent |
Kyowa Kirin Holdings B.V. Bloemlaan 2, 2132 NP Hoofddorp, Nederland |
EU/1/10/644 |
27.03.2024 |
| 25.03.2024 |
Rapiscan |
GE Healthcare AS Nycoveien 1, 0485, Oslo, Norge
|
EU/1/10/643 |
26.03.2024 |
| 25.03.2024 |
Sutent |
Pfizer Europe MA EEIG Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België |
EU/1/06/347 |
26.03.2024 |
| 25.03.2024 |
Zolgensma |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/20/1443 |
27.03.2024 |
| 26.03.2024 |
Glivec |
Novartis Europharm Limited Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland |
EU/1/01/198 |
02.04.2024 |
| 27.03.2024 |
Anagrelide Viatris |
Viatris Limited Damastown Industrial Park, Mul- huddart, Dublin 15, Ireland
|
EU/1/17/1256 |
02.04.2024 |
| 27.03.2024 |
Brilique |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/10/655 |
02.04.2024 |
| 27.03.2024 |
Cetrotide |
Merck Europe B.V. Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland
|
EU/1/99/100 |
03.04.2024 |
| 27.03.2024 |
Effentora |
Teva B.V. Swensweg 5, 2031 GA Haarlem, Nederland
|
EU/1/08/441 |
03.04.2024 |
| 27.03.2024 |
Febuxostat Krka |
KRKA d d., Novo mesto Smarjeska cesta 6, 8501 Novo mesto, Slovenija |
EU/1/18/1347 |
04.04.2024 |
| 27.03.2024 |
Instanyl |
Takeda Pharma A/S Delta Park 45, 2665 Vallensbaek Strand, Danmark
|
EU/1/09/531 |
03.04.2024 |
| 27.03.2024 |
Myclausen |
Passauer Pharma GmbH Eiderstedter Weg 3, 14129 Berlin, Deutschland |
EU/1/10/647 |
04.04.2024 |
| 27.03.2024 |
Nexium Control |
GlaxoSmithKline Dungarvan Limited Dungarvan, Co. Waterford, Ireland
|
EU/1/13/860 |
02.04.2024 |
| 27.03.2024 |
Ocrevus |
Roche Registration GmbH Emil-Barell-Strasse 1, 79639 Gren- zach-Wyhlen, Deutschland |
EU/1/17/1231 |
02.04.2024 |
| 27.03.2024 |
Prasugrel Viatris |
Viatris Limited Damastown Industrial Park, Mul- huddart, Dublin 15, Ireland
|
EU/1/18/1273 |
02.04.2024 |
| 27.03.2024 |
Puregon |
N.V. Organon Kloosterstraat 6, 5349 AB Oss, Nederland
|
EU/1/96/008 |
02.04.2024 |
| 27.03.2024 |
Reblozyl |
Bristol-Myers Squibb Pharma EEIG Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland |
EU/1/20/1452 |
02.04.2024 |
| 27.03.2024 |
Repatha |
Amgen Europe B.V. Minervum 7061, 4817 ZK Breda, Nederland
|
EU/1/15/1016 |
02.04.2024 |
| 27.03.2024 |
Rybelsus |
Novo Nordisk A/S Novo Allé, 2880 Bagsvaerd, Danmark
|
EU/1/20/1430 |
03.04.2024 |
| 27.03.2024 |
Segluromet |
Merck Sharp & Dohme B.V. Waarderweg 39, 2031 BN Haarlem, Nederland |
EU/1/18/1265 |
02.04.2024 |
| 27.03.2024 |
Sixmo |
L. Molteni & C. dei F.lli Alitti Società di .Esercizio .S.p.A Strada Statale 67, Loc. Granatieri, 50018 Scandicci (Firenze), Italia
|
EU/1/19/1369 |
02.04.2024 |
| 27.03.2024 |
Uptravi |
Janssen-Cilag International NV Turnhoutseweg 30, 2340 Beerse, België |
EU/1/15/1083 |
02.04.2024 |
| 27.03.2024 |
Vaxzevria |
AstraZeneca AB 151 85 Södertälje, Sverige
|
EU/1/21/1529 |
02.04.2024 |
