|
Data wydania decyzji
|
Nazwa produktu leczniczego
|
Posiadacz pozwolenia na dopuszczenie do obrotu
|
Numer pozycji w rejestrze wspólnotowym
|
Data notyfikacji
|
|
4.5.2026
|
Abiraterone Mylan
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/21/1571
|
8.5.2026
|
|
4.5.2026
|
Circadin
|
|
RAD Neurim Pharmaceuticals EEC SARL
|
|
4 rue de Marivaux, 75002 Paris, France
|
|
EU/1/07/392
|
7.5.2026
|
|
4.5.2026
|
Clopidogrel/Acetylsalicylic acid Viatris
|
|
Viatris Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/19/1395
|
5.5.2026
|
|
4.5.2026
|
Entyvio
|
|
Takeda Pharma A/S
|
|
Delta Park 45, 2665 Vallensbaek Strand, Danmark
|
|
EU/1/14/923
|
5.5.2026
|
|
4.5.2026
|
Epysqli
|
|
Samsung Bioepis NL B.V.
|
|
Olof Palmestraat 10, 2616 LR Delft, Nederland
|
|
EU/1/23/1735
|
8.5.2026
|
|
4.5.2026
|
KAVIGALE
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/24/1900
|
5.5.2026
|
|
4.5.2026
|
Kisplyx
|
|
Eisai GmbH
|
|
Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland
|
|
EU/1/16/1128
|
5.5.2026
|
|
4.5.2026
|
Movymia
|
|
STADA Arzneimittel AG
|
|
Stadastraße 2-18, 61118 Bad Vilbel, Deutschland
|
|
EU/1/16/1161
|
5.5.2026
|
|
4.5.2026
|
Pyzchiva
|
|
Samsung Bioepis NL B.V.
|
|
Olof Palmestraat 10, 2616 LR Delft, Nederland
|
|
EU/1/24/1801
|
6.5.2026
|
|
4.5.2026
|
Stivarga
|
|
Bayer AG
|
|
D-51368 Leverkusen, Deutschland
|
|
EU/1/13/858
|
11.5.2026
|
|
4.5.2026
|
Tecartus
|
|
Kite Pharma EU B.V.
|
|
Tufsteen 1, 2132 NT Hoofddorp, Nederland
|
|
EU/1/20/1492
|
12.5.2026
|
|
4.5.2026
|
Tuznue
|
|
Prestige Biopharma Belgium BVBA
|
|
Terhulpensesteenweg 449, 3090 Overijse, België
|
|
EU/1/24/1864
|
5.5.2026
|
|
4.5.2026
|
Velsipity
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/23/1790
|
5.5.2026
|
|
4.5.2026
|
Zubsolv
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
|
EU/1/17/1233
|
5.5.2026
|
|
6.5.2026
|
Besponsa
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/17/1200
|
7.5.2026
|
|
6.5.2026
|
Kymriah
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/18/1297
|
7.5.2026
|
|
6.5.2026
|
Veklury
|
|
Gilead Sciences Ireland UC
|
|
Carrigtohill, County Cork, T45 DP77, Ireland
|
|
EU/1/20/1459
|
7.5.2026
|
|
11.5.2026
|
Azilect
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/04/304
|
12.5.2026
|
|
11.5.2026
|
Docetaxel Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/12/769
|
12.5.2026
|
|
11.5.2026
|
Efmody
|
|
Immedica Pharma AB
|
|
SE-113 63, Stockholm, Sverige
|
|
EU/1/21/1549
|
12.5.2026
|
|
11.5.2026
|
Epruvy
|
|
Midas Pharma GmbH
|
|
Rheinstraße 49, D-55218 Ingelheim, Deutschland
|
|
EU/1/24/1860
|
13.5.2026
|
|
11.5.2026
|
Hympavzi
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/24/1874
|
12.5.2026
|
|
11.5.2026
|
Lenvima
|
|
Eisai GmbH
|
|
Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland
|
|
EU/1/15/1002
|
12.5.2026
|
|
11.5.2026
|
Levetiracetam SUN
|
|
Sun Pharmaceutical Industries Europe BV
|
|
Polarisavenue 87, 2132 JH Hoofddorp, Nederland
|
|
EU/1/11/741
|
14.5.2026
|
|
11.5.2026
|
Pazenir
|
|
ratiopharm GmbH
|
|
Graf-Arco-Straße 3, 89079 Ulm, Deutschland
|
|
EU/1/18/1317
|
13.5.2026
|
|
11.5.2026
|
Piasky
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/24/1848
|
12.5.2026
|
|
11.5.2026
|
Pluvicto
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/22/1703
|
12.5.2026
|
|
11.5.2026
|
Ruxience
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/20/1431
|
12.5.2026
|
|
11.5.2026
|
Simulect
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/98/084
|
12.5.2026
|
|
11.5.2026
|
Sitagliptin/Metformin hydrochloride SUN
|
|
Sun Pharmaceutical Industries Europe B.V.
|
|
Polarisavenue 87, 2132JH Hoofddorp, Nederland
|
|
EU/1/23/1720
|
22.5.2026
|
|
11.5.2026
|
Tolura
|
|
KRKA d d., Novo mesto
|
|
Šmarješka cesta 6, 8501 Novo mesto, Slovenija
|
|
EU/1/10/632
|
12.5.2026
|
|
11.5.2026
|
Vevizye
|
|
Laboratoires Thea
|
|
12 Rue Louis Bleriot, 63100 Clermont-Ferrand, France
|
|
EU/1/24/1857
|
12.5.2026
|
|
13.5.2026
|
Ebymect
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/15/1051
|
13.5.2026
|
|
13.5.2026
|
Matever
|
|
Pharmathen S.A.
|
|
6 Dervenakion, 15351 Pallini Attiki, Ελλάδα
|
|
EU/1/11/711
|
18.5.2026
|
|
13.5.2026
|
Obodence
|
|
Samsung Bioepis NL B.V.
|
|
Olof Palmestraat 10, 2616 LR Delft, Nederland
|
|
EU/1/24/1890
|
18.5.2026
|
|
13.5.2026
|
Opuviz
|
|
Samsung Bioepis NL B.V.
|
|
Olof Palmestraat 10, 2616 LR Delft, Nederland
|
|
EU/1/24/1865
|
14.5.2026
|
|
13.5.2026
|
Pregabalin Viatris Pharma
|
|
Viatris Healthcare Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
|
|
EU/1/14/916
|
13.5.2026
|
|
13.5.2026
|
Rytelo
|
|
Geron Netherlands B.V.
|
|
La Guardiaweg 58, 1043 DJ Amsterdam, Nederland
|
|
EU/1/24/1894
|
26.5.2026
|
|
13.5.2026
|
Tarceva
|
|
CHEPLAPHARM Registration GmbH
|
|
Weiler Straße 5e, 79540 Lörrach, Deutschland
|
|
EU/1/05/311
|
13.5.2026
|
|
13.5.2026
|
Upstaza
|
|
PTC Therapeutics International Limited
|
|
70 Sir John Rogerson's Quay, Dublin 2, Ireland
|
|
EU/1/22/1653
|
18.5.2026
|
|
21.5.2026
|
ALTUVOCT
|
|
Swedish Orphan Biovitrum AB (publ)
|
|
112 76 Stockholm, Sverige
|
|
EU/1/24/1824
|
27.5.2026
|
|
21.5.2026
|
Caprelsa
|
|
Esteve Pharmaceuticals S.A.
|
|
Passeig de La Zona Franca 109 Planta 4, 08038 Barcelona, España
|
|
EU/1/11/749
|
22.5.2026
|
|
21.5.2026
|
Duloxetine Zentiva
|
|
Zentiva, k.s.
|
|
U Kabelovny 130, 102 37 Praha 10, Česká republika
|
|
EU/1/15/1028
|
22.5.2026
|
|
21.5.2026
|
DUVYZAT
|
|
Italfarmaco S.p.A.
|
|
Viale F. Testi, 330, 20126 Milano, Italia
|
|
EU/1/25/1930
|
22.5.2026
|
|
21.5.2026
|
Eltrombopag Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/24/1903
|
22.5.2026
|
|
21.5.2026
|
Eltrombopag Viatris
|
|
Viatris Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
|
|
EU/1/24/1869
|
25.5.2026
|
|
21.5.2026
|
Evra
|
|
Gedeon Richter Plc.
|
|
Gyömrői út 19-21, 1103 Budapest, Magyarország
|
|
EU/1/02/223
|
29.5.2026
|
|
21.5.2026
|
Fingolimod Mylan
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/21/1573
|
25.5.2026
|
|
21.5.2026
|
Fycompa
|
|
Eisai GmbH
|
|
Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland
|
|
EU/1/12/776
|
22.5.2026
|
|
21.5.2026
|
Ilumetri
|
|
Almirall, S.A.
|
|
Ronda General Mitre, 151, 08022 Barcelona, España
|
|
EU/1/18/1323
|
27.5.2026
|
|
21.5.2026
|
Inflectra
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/13/854
|
22.5.2026
|
|
21.5.2026
|
KANJINTI
|
|
Amgen Europe B.V.
|
|
Minervum 7061, 4817 ZK Breda, Nederland
|
|
EU/1/18/1281
|
26.5.2026
|
|
21.5.2026
|
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
|
22.5.2026
|
|
21.5.2026
|
Lunsumio
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/22/1649
|
22.5.2026
|
|
21.5.2026
|
Lytgobi
|
|
Taiho Pharma Netherlands B.V.
|
|
Barbara Strozzilaan 201, 1083 HN Amsterdam, Noord-Holland, Nederland
|
|
EU/1/23/1741
|
28.5.2026
|
|
21.5.2026
|
PAVBLU
|
|
Amgen Technology (Ireland) UC
|
|
Pottery Road, Dun Laoghaire, Co. Dublin, A96 F2A8, Ireland
|
|
EU/1/25/1909
|
25.5.2026
|
|
21.5.2026
|
Pelgraz
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/18/1313
|
22.5.2026
|
|
21.5.2026
|
Pemetrexed Pfizer
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/15/1057
|
22.5.2026
|
|
21.5.2026
|
Pyrukynd
|
|
Agios Netherlands B.V.
|
|
Zuidplein 36, Regus Amsterdam WTC, 1077XV Amsterdam, Nederland
|
|
EU/1/22/1662
|
22.5.2026
|
|
21.5.2026
|
Somavert
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/02/240
|
22.5.2026
|
|
21.5.2026
|
Talzenna
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/19/1377
|
22.5.2026
|
|
21.5.2026
|
TECVAYLI
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/22/1675
|
22.5.2026
|
|
21.5.2026
|
Valdoxan
|
|
Les Laboratoires Servier
|
|
50 rue Carnot, 92284 Suresnes CEDEX, France
|
|
EU/1/08/499
|
22.5.2026
|
|
21.5.2026
|
Yesintek
|
|
Biosimilar Collaborations Ireland Limited
|
|
Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland
|
|
EU/1/24/1892
|
25.5.2026
|
|
26.5.2026
|
Atazanavir Viatris
|
|
Viatris Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/16/1091
|
27.5.2026
|
|
26.5.2026
|
Byooviz
|
|
Samsung Bioepis NL B.V.
|
|
Olof Palmestraat 10, 2616 LR Delft, Nederland
|
|
EU/1/21/1572
|
28.5.2026
|
|
26.5.2026
|
Calquence
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/20/1479
|
27.5.2026
|
|
26.5.2026
|
Cometriq
|
|
Ipsen Pharma
|
|
70 rue Balard, 75015 Paris, France
|
|
EU/1/13/890
|
28.5.2026
|
|
26.5.2026
|
Comirnaty
|
|
BioNTech Manufacturing GmbH
|
|
An der Goldgrube 12, 55131 Mainz, Deutschland
|
|
EU/1/20/1528
|
27.5.2026
|
|
26.5.2026
|
Feraccru
|
|
Norgine B.V.
|
|
Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland
|
|
EU/1/15/1075
|
27.5.2026
|
|
26.5.2026
|
Galvus
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/07/414
|
27.5.2026
|
|
26.5.2026
|
Iasibon
|
|
Pharmathen S.A.
|
|
6 Dervenakion, 15351 Pallini Attiki, Ελλάδα
|
|
EU/1/10/659
|
28.5.2026
|
|
26.5.2026
|
Jalra
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/08/485
|
27.5.2026
|
|
26.5.2026
|
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
|
27.5.2026
|
|
26.5.2026
|
Mabthera
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/98/067
|
27.5.2026
|
|
26.5.2026
|
Memantine Merz
|
|
Merz Pharmaceuticals GmbH
|
|
Eckenheimer Landstraße 100 D-60318 Frankfurt am Main, Deutschland
|
|
EU/1/12/799
|
9.6.2026
|
|
26.5.2026
|
PREVYMIS
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/17/1245
|
27.5.2026
|
|
26.5.2026
|
Privigen
|
|
CSL Behring GmbH
|
|
Emil-von-Behring-Straße 76, 35041 Marburg, Deutschland
|
|
EU/1/08/446
|
28.5.2026
|
|
26.5.2026
|
Qdenga
|
|
Takeda Pharmaceuticals International AG
|
|
Block 2 Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, Co. Dublin, D02 HW68, Ireland
|
|
EU/1/22/1699
|
28.5.2026
|
|
26.5.2026
|
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
|
27.5.2026
|
|
26.5.2026
|
Truxima
|
|
Celltrion Healthcare Hungary Kft.
|
|
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
|
|
EU/1/16/1167
|
3.6.2026
|
|
26.5.2026
|
Venclyxto
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/16/1138
|
27.5.2026
|
|
26.5.2026
|
Xiliarx
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/08/486
|
27.5.2026
|
|
28.5.2026
|
CARVYKTI
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/22/1648
|
29.5.2026
|
|
28.5.2026
|
Kapruvia
|
|
Vifor Fresenius Medical Care Renal Pharma France
|
|
100-101 terrasse Boieldieu, Tour Franklin La Défense 8, 92042 Paris la Défense Cedex, France
|
|
EU/1/22/1643
|
29.5.2026
|
|
28.5.2026
|
Namuscla
|
|
Lupin Europe GmbH
|
|
Hanauer Landstraße 139-143, 60314 Frankfurt am Main, Deutschland
|
|
EU/1/18/1325
|
29.5.2026
|
|
28.5.2026
|
Nemluvio
|
|
Galderma International
|
|
La Defense 4, Tour Europlaza, 20 Avenue Andre Prothin, 92927 Paris La Defense Cedex, France
|
|
EU/1/24/1901
|
29.5.2026
|
|
28.5.2026
|
OPDIVO
|
|
Bristol-Myers Squibb Pharma EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland
|
|
EU/1/15/1014
|
29.5.2026
|
|
28.5.2026
|
TachoSil
|
|
Corza Medical GmbH
|
|
Speditionstraße 21, 40221 Düsseldorf, Deutschland
|
|
EU/1/04/277
|
29.5.2026
|
|
29.5.2026
|
AGAMREE
|
|
Santhera Pharmaceuticals (Deutschland) GmbH
|
|
Marie-Curie Straße 8, 79539 Lörrach, Deutschland
|
|
EU/1/23/1776
|
3.6.2026
|
|
29.5.2026
|
AQUIPTA
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/23/1750
|
1.6.2026
|
|
29.5.2026
|
CRYSVITA
|
|
Kyowa Kirin Holdings B.V.
|
|
Bloemlaan 2, 2132 NP Hoofddorp, Nederland
|
|
EU/1/17/1262
|
2.6.2026
|
|
29.5.2026
|
Dabigatran etexilate Teva
|
|
Teva GmbH
|
|
Graf-Arco-Straße 3, 89079 Ulm, Deutschland
|
|
EU/1/23/1769
|
1.6.2026
|
|
29.5.2026
|
Ifirmasta
|
|
KRKA d d., Novo mesto
|
|
Šmarješka cesta 6, 8501 Novo mesto, Slovenija
|
|
EU/1/08/480
|
1.6.2026
|
|
29.5.2026
|
Irbesartan HCT Zentiva
|
|
Zentiva k.s.
|
|
U kabelovny 130, 102 37 Praha 10, Česká republika
|
|
EU/1/06/377
|
2.6.2026
|
|
29.5.2026
|
Levetiracetam ratiopharm
|
|
ratiopharm GmbH
|
|
Graf-Arco-Straße 3, 89079 Ulm, Deutschland
|
|
EU/1/11/702
|
2.6.2026
|
|
29.5.2026
|
Levetiracetam Teva
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/11/701
|
1.6.2026
|
|
29.5.2026
|
Lopinavir/Ritonavir Viatris
|
|
Viatris Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/15/1067
|
2.6.2026
|
|
29.5.2026
|
LysaKare
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/19/1381
|
3.6.2026
|
|
29.5.2026
|
Synjardy
|
|
Boehringer Ingelheim International GmbH
|
|
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland
|
|
EU/1/15/1003
|
8.6.2026
|
|
29.5.2026
|
Tecovirimat SIGA
|
|
SIGA Technologies Netherlands B.V.
|
|
Prinsenhil 29, Breda 4825 AX, Nederland
|
|
EU/1/21/1600
|
2.6.2026
|
