|
Data da decisão
|
Nome do medicamento
|
Titular da autorização de introdução no mercado
|
Número de inscrição no Registo Comunitário
|
Data de notificação
|
|
6.5.2024
|
ASPAVELI
|
|
Swedish Orphan Biovitrum AB (publ)
|
|
112 76 Stockholm, Sverige
|
|
EU/1/21/1595
|
7.5.2024
|
|
6.5.2024
|
Circadin
|
|
RAD Neurim Pharmaceuticals EEC SARL
|
|
4 rue de Marivaux, 75002 Paris, France
|
|
EU/1/07/392
|
7.5.2024
|
|
6.5.2024
|
Eliquis
|
|
Bristol-Myers Squibb/Pfizer EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
|
|
EU/1/11/691
|
8.5.2024
|
|
6.5.2024
|
Epclusa
|
|
Gilead Sciences Ireland UC
|
|
Carrigtohill, County Cork, T45 DP77, Ireland
|
|
EU/1/16/1116
|
7.5.2024
|
|
6.5.2024
|
Fendrix
|
|
GlaxoSmithKline Biologicals S.A.
|
|
rue de l'Institut 89, 1330 Rixensart, Belgique
|
|
EU/1/04/299
|
8.5.2024
|
|
6.5.2024
|
Kanuma
|
|
Alexion Europe SAS
|
|
103-105 rue Anatole France, 92300 Levallois-Perret, France
|
|
EU/1/15/1033
|
7.5.2024
|
|
6.5.2024
|
Kisplyx
|
|
Eisai GmbH
|
|
Edmund-Rumpler-Strasse 3, 60549 Frankfurt am Main, Deutschland
|
|
EU/1/16/1128
|
7.5.2024
|
|
6.5.2024
|
Orphacol
|
|
THERAVIA
|
|
16 Rue Montrosier, 92200 Neuilly-sur-Seine, France
|
|
EU/1/13/870
|
14.5.2024
|
|
6.5.2024
|
VEGZELMA
|
|
Celltrion Healthcare Hungary Kft.
|
|
Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
|
|
EU/1/22/1667
|
7.5.2024
|
|
6.5.2024
|
Xenical
|
|
CHEPLAPHARM Arzneimittel GmbH
|
|
Ziegelhof 24, 17489 Greifswald, Deutschland
|
|
EU/1/98/071
|
8.5.2024
|
|
10.5.2024
|
Armisarte
|
|
Actavis Group PTC ehf.
|
|
Dalshraun 1, 220 Hafnarfjörður, Íceland
|
|
EU/1/15/1063
|
13.5.2024
|
|
10.5.2024
|
Darunavir Mylan
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/16/1140
|
13.5.2024
|
|
10.5.2024
|
Fingolimod Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/20/1450
|
13.5.2024
|
|
10.5.2024
|
Lojuxta
|
|
Amryt Pharmaceuticals DAC
|
|
45 Mespil Road, Dublin 4, Ireland
|
|
EU/1/13/851
|
15.5.2024
|
|
10.5.2024
|
Nilemdo
|
|
Daiichi Sankyo Europe GmbH
|
|
Zielstattstraße 48, 81379 München, Deutschland
|
|
EU/1/20/1425
|
13.5.2024
|
|
10.5.2024
|
Nustendi
|
|
Daiichi Sankyo Europe GmbH
|
|
Zielstattstraße 48, 81379 München, Deutschland
|
|
EU/1/20/1424
|
14.5.2024
|
|
10.5.2024
|
PreHevbri
|
|
VBI Vaccines B.V.
|
|
Delflandlaan 1, Queen’s Tower Office Number 714, 1062 EA Amsterdam, Nederland
|
|
EU/1/22/1641
|
15.5.2024
|
|
10.5.2024
|
QUVIVIQ
|
|
Idorsia Pharmaceuticals Deutschland GmbH
|
|
Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland
|
|
EU/1/22/1638
|
14.5.2024
|
|
10.5.2024
|
Revolade
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/10/612
|
13.5.2024
|
|
10.5.2024
|
Thalidomide Lipomed
|
|
Lipomed GmbH
|
|
Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland
|
|
EU/1/22/1676
|
13.5.2024
|
|
10.5.2024
|
Thyrogen
|
|
Sanofi B.V.
|
|
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
|
EU/1/99/122
|
14.5.2024
|
|
10.5.2024
|
Trevicta
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/14/971
|
14.5.2024
|
|
10.5.2024
|
Tyverb
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/07/440
|
14.5.2024
|
|
15.5.2024
|
Comirnaty
|
|
BioNTech Manufacturing GmbH
|
|
An der Goldgrube 12, 55131 Mainz, Deutschland
|
|
EU/1/20/1528
|
16.5.2024
|
|
16.5.2024
|
AMGEVITA
|
|
Amgen Europe B.V.
|
|
Minervum 7061, 4817 ZK Breda, Nederland
|
|
EU/1/16/1164
|
17.5.2024
|
|
16.5.2024
|
Bondronat
|
|
Atnahs Pharma Netherlands B.V.
|
|
Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark
|
|
EU/1/96/012
|
17.5.2024
|
|
16.5.2024
|
Cufence
|
|
Univar Solutions B.V.
|
|
Schouwburgplein 30, Rotterdam, 3012 CL, Nederland
|
|
EU/1/19/1365
|
21.5.2024
|
|
16.5.2024
|
Giapreza
|
|
PAION Deutschland GmbH
|
|
Heussstraße 25, 52078 Aachen, Deutschland
|
|
EU/1/19/1384
|
17.5.2024
|
|
16.5.2024
|
IBRANCE
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/16/1147
|
17.5.2024
|
|
16.5.2024
|
Imvanex
|
|
Bavarian Nordic A/S
|
|
Philip Heymans Allé 3, DK-2900 Hellerup, Danmark
|
|
EU/1/13/855
|
30.5.2024
|
|
16.5.2024
|
Lumykras
|
|
Amgen Europe B.V.
|
|
Minervum 7061, 4817 ZK Breda, Nederland
|
|
EU/1/21/1603
|
17.5.2024
|
|
16.5.2024
|
NUBEQA
|
|
Bayer AG
|
|
D-51368 Leverkusen, Deutschland
|
|
EU/1/20/1432
|
17.5.2024
|
|
16.5.2024
|
PecFent
|
|
Grünenthal GmbH
|
|
Zieglerstraße 6, 52078, Aachen, Deutschland
|
|
EU/1/10/644
|
22.5.2024
|
|
16.5.2024
|
Rinvoq
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/19/1404
|
17.5.2024
|
|
16.5.2024
|
Rozlytrek
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/20/1460
|
17.5.2024
|
|
16.5.2024
|
Rybrevant
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/21/1594
|
17.5.2024
|
|
16.5.2024
|
Saphnelo
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/21/1623
|
17.5.2024
|
|
16.5.2024
|
Vipidia
|
|
Takeda Pharma A/S
|
|
Delta Park 45, 2665 Vallensbaek Strand, Danmark
|
|
EU/1/13/844
|
21.5.2024
|
|
16.5.2024
|
Xromi
|
|
Nova Laboratories Ireland Limited
|
|
3rd Floor, Ulysses House, Foley Street, Dublin 1, D01 W2T2, Ireland
|
|
EU/1/19/1366
|
20.5.2024
|
|
17.5.2024
|
Cloreto de metiltionina Proveblue
|
|
Provepharm S.A.S.
|
|
22 rue Marc Donadille, 13013 Marseille, France
|
|
EU/1/11/682
|
22.5.2024
|
|
17.5.2024
|
Grasustek
|
|
Juta Pharma GmbH
|
|
Gutenbergstr. 13, 24941, Flensburg, Deutschland
|
|
EU/1/19/1375
|
23.5.2024
|
|
17.5.2024
|
Levetiracetam Actavis
|
|
Actavis Group PTC ehf.
|
|
Dalshraun 1, 220 Hafnarfjörður, Íceland
|
|
EU/1/11/713
|
21.5.2024
|
|
17.5.2024
|
NUCEIVA
|
|
Evolus Pharma B.V.
|
|
Apollolaan 151, 1077 AR Amsterdam, Nederland
|
|
EU/1/19/1364
|
21.5.2024
|
|
17.5.2024
|
Oxbryta
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/21/1622
|
21.5.2024
|
|
17.5.2024
|
Qdenga
|
|
Takeda GmbH
|
|
Byk-Gulden-Straße 2, 78467 Konstanz, Deutschland
|
|
EU/1/22/1699
|
21.5.2024
|
|
17.5.2024
|
TRISENOX
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/02/204
|
22.5.2024
|
|
21.5.2024
|
Rivaroxaban Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
|
EU/1/20/1488
|
22.5.2024
|
|
22.5.2024
|
BEKEMV
|
|
Amgen Technology (Ireland) UC
|
|
Pottery Road, Dun Laoghaire, Co. Dublin, Ireland
|
|
EU/1/23/1727
|
24.5.2024
|
|
22.5.2024
|
BiResp Spiromax
|
|
Teva Pharma B.V.
|
|
Swensweg 5, 2031GA Haarlem, Nederland
|
|
EU/1/14/921
|
28.5.2024
|
|
22.5.2024
|
Bosulif
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/13/818
|
23.5.2024
|
|
22.5.2024
|
Buccolam
|
|
Neuraxpharm Pharmaceuticals, S.L.
|
|
Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, España
|
|
EU/1/11/709
|
24.5.2024
|
|
22.5.2024
|
DuoResp Spiromax
|
|
Teva Pharma B.V.
|
|
Swensweg 5, 2031GA Haarlem, Nederland
|
|
EU/1/14/920
|
28.5.2024
|
|
22.5.2024
|
Ebilfumin
|
|
Actavis Group PTC ehf.
|
|
Dalshraun 1, 220 Hafnarfjörður, Íceland
|
|
EU/1/14/915
|
23.5.2024
|
|
22.5.2024
|
Eptifibatide Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
|
EU/1/15/1065
|
23.5.2024
|
|
22.5.2024
|
EVOTAZ
|
|
Bristol-Myers Squibb Pharma EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland
|
|
EU/1/15/1025
|
23.5.2024
|
|
22.5.2024
|
Karvezide
|
|
Sanofi Winthrop Industrie
|
|
82 avenue Raspail, 94250 Gentilly, France
|
|
EU/1/98/085
|
24.5.2024
|
|
22.5.2024
|
Komboglyze
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/11/731
|
24.5.2024
|
|
22.5.2024
|
Lytgobi
|
|
Taiho Pharma Netherlands B.V.
|
|
Barbara Strozzilaan 201, 1083 HN Amsterdam, Noord-Holland, Nederland
|
|
EU/1/23/1741
|
29.5.2024
|
|
22.5.2024
|
Menveo
|
|
GSK Vaccines S.r.l.
|
|
Via Fiorentina 1, 53100 Siena, Italia
|
|
EU/1/10/614
|
27.5.2024
|
|
22.5.2024
|
Opzelura
|
|
Incyte Biosciences Distribution B.V.
|
|
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
|
EU/1/23/1726
|
23.5.2024
|
|
22.5.2024
|
Procysbi
|
|
Chiesi Farmaceutici S.p.A.
|
|
Via Palermo 26/A, 43122 Parma, Italia
|
|
EU/1/13/861
|
29.5.2024
|
|
22.5.2024
|
Ratiograstim
|
|
ratiopharm GmbH
|
|
Graf-Arco-Straße 3, 89079 Ulm, Deutschland
|
|
EU/1/08/444
|
3.6.2024
|
|
22.5.2024
|
Sialanar
|
|
Proveca Pharma Limited
|
|
2 Dublin Landings, North Wall Quay, Dublin 1, Ireland
|
|
EU/1/16/1135
|
23.5.2024
|
|
23.5.2024
|
Evrenzo
|
|
Astellas Pharma Europe B.V.
|
|
Sylviusweg 62, 2333 BE Leiden, Nederland
|
|
EU/1/21/1574
|
23.5.2024
|
|
23.5.2024
|
Levetiracetam ratiopharm
|
|
ratiopharm GmbH
|
|
Graf-Arco-Straße 3, 89079 Ulm, Deutschland
|
|
EU/1/11/702
|
28.5.2024
|
|
23.5.2024
|
Levetiracetam Teva
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/11/701
|
23.5.2024
|
|
23.5.2024
|
OPDIVO
|
|
Bristol-Myers Squibb Pharma EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland
|
|
EU/1/15/1014
|
23.5.2024
|
|
27.5.2024
|
Aimovig
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/18/1293
|
28.5.2024
|
|
27.5.2024
|
Camcevi
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/22/1647
|
28.5.2024
|
|
27.5.2024
|
Columvi
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/23/1742
|
28.5.2024
|
|
27.5.2024
|
Imfinzi
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/18/1322
|
28.5.2024
|
|
27.5.2024
|
IMJUDO
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/22/1713
|
28.5.2024
|
|
27.5.2024
|
Reyataz
|
|
Bristol-Myers Squibb Pharma EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland
|
|
EU/1/03/267
|
28.5.2024
|
|
27.5.2024
|
Triumeq
|
|
ViiV Healthcare BV
|
|
Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland
|
|
EU/1/14/940
|
28.5.2024
|
|
29.5.2024
|
BLINCYTO
|
|
Amgen Europe B.V.
|
|
Minervum 7061, 4817 ZK Breda, Nederland
|
|
EU/1/15/1047
|
26.4.2024
|
|
29.5.2024
|
BLINCYTO
|
|
Amgen Europe B.V.
|
|
Minervum 7061, 4817 ZK Breda, Nederland
|
|
EU/1/15/1047
|
30.5.2024
|
|
29.5.2024
|
Cerdelga
|
|
Sanofi B.V.
|
|
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
|
EU/1/14/974
|
31.5.2024
|
|
29.5.2024
|
Desloratadina Actavis
|
|
Actavis Group PTC ehf.
|
|
Dalshraun 1, 220 Hafnarfjörður, Íceland
|
|
EU/1/11/745
|
1.6.2024
|
|
29.5.2024
|
Efavirenz/Emtricitabina/Tenofovir disoproxil Zentiva
|
|
Zentiva, k.s.
|
|
U Kabelovny 130, 102 37 Praha 10, Česká republika
|
|
EU/1/17/1210
|
30.5.2024
|
|
29.5.2024
|
Emtricitabine/Tenofovir disoproxil Krka
|
|
KRKA d d., Novo mesto
|
|
Šmarješka cesta 6, 8501 Novo mesto, Slovenija
|
|
EU/1/16/1151
|
30.5.2024
|
|
29.5.2024
|
Emtricitabine /Tenofovir disoproxil Krka d.d.
|
|
KRKA d d., Novo mesto
|
|
Šmarješka cesta 6, 8501 Novo mesto, Slovenija
|
|
EU/1/17/1182
|
6.6.2024
|
|
29.5.2024
|
Myocet liposomal
|
|
CHEPLAPHARM Arzneimittel GmbH
|
|
Ziegelhof 24, 17489 Greifswald, Deutschland
|
|
EU/1/00/141
|
3.6.2024
|
|
29.5.2024
|
Omidria
|
|
Rayner Surgical (Ireland) Limited
|
|
The Mill Enterprise Hub, Newtown Link Road, Drogheda, A92 CD3D, Co. Louth, Ireland
|
|
EU/1/15/1018
|
4.6.2024
|
|
29.5.2024
|
Pregabalina Sandoz
|
|
Sandoz GmbH
|
|
Biochemiestrasse 10, 6250 Kundl, Österreich
|
|
EU/1/15/1011
|
6.6.2024
|
