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Datum rozhodnutí
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Název léčivého přípravku
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Držitel rozhodnutí o registraci
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Číslo zápisu do rejstříku Společenství
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Datum oznámení
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3.9.2026
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Abecma
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Bristol-Myers Squibb Pharma EEIG
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Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland
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EU/1/21/1539
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4.9.2026
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3.9.2026
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JERAYGO
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Idorsia Pharmaceuticals Deutschland GmbH
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Marie-Curie-Strasse 8, 79539 Lörrach, Deutschland
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EU/1/24/1818
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8.9.2026
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3.9.2026
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Miglustat Gen.Orph
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Gen.Orph
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185 Bureaux de la Colline, 92213 Saint Cloud Cedex, France
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EU/1/17/1232
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4.9.2026
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3.9.2026
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Symtuza
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Janssen-Cilag International NV
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Turnhoutseweg 30, 2340 Beerse, België
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EU/1/17/1225
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4.9.2026
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3.9.2026
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Zimbus Breezhaler
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Novartis Europharm Limited
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Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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EU/1/20/1440
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4.9.2026
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11.9.2026
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Amlodipin/Valsartan Mylan
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Mylan Pharmaceuticals Limited
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Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
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EU/1/16/1092
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14.9.2026
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11.9.2026
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BEYONTTRA
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Bayer AG
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51368 Leverkusen, Deutschland
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EU/1/24/1906
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14.9.2026
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11.9.2026
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Brintellix
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H. Lundbeck A/S
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Ottiliavej 9, 2500 Valby, Danmark
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EU/1/13/891
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14.9.2026
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11.9.2026
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Lixiana
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Daiichi Sankyo Europe GmbH
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Zielstattstraße 48, 81379 München, Deutschland
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EU/1/15/993
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15.9.2026
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11.9.2026
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Prolia
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Amgen Europe B.V.
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Minervum 7061, 4817 ZK Breda, Nederland
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EU/1/10/618
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15.9.2026
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11.9.2026
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Riluzole Zentiva
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Zentiva k.s.
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U kabelovny 130, 102 37 Praha 10, Česká republika
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EU/1/12/768
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14.9.2026
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11.9.2026
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Rivaroxaban Accord
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Accord Healthcare S.L.U.
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World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
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EU/1/20/1488
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14.9.2026
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11.9.2026
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Wezenla
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Amgen Technology (Ireland) UC
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Pottery Road, Dun Laoghaire, Co. Dublin, Ireland
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EU/1/24/1823
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10.8.2026
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11.9.2026
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Wezenla
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Amgen Technology (Ireland) UC
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Pottery Road, Dun Laoghaire, Co. Dublin, Ireland
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EU/1/24/1823
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14.9.2026
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11.9.2026
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Zokinvy
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Integral Pharma Solutions EU Limited
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1 Windmill Lane, Dublin 2, Co. Dublin, D02 F206, Ireland
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EU/1/22/1660
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14.9.2026
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|
11.9.2026
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Zolgensma
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Novartis Europharm Limited
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Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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EU/1/20/1443
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18.9.2026
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|
11.9.2026
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Zonegran
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Amdipharm Limited
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Unit 17, Northwood House, Northwood Crescent, Northwood, Dublin 9, D09 V504, Ireland
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EU/1/04/307
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22.9.2026
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|
14.9.2026
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Firazyr
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Takeda Pharmaceuticals International AG Ireland Branch
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Block 2, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland
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EU/1/08/461
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15.9.2026
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14.9.2026
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Herwenda
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Sandoz GmbH
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Biochemiestrasse 10, 6250 Kundl, Österreich
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EU/1/23/1762
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15.9.2026
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14.9.2026
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IMBRUVICA
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Janssen-Cilag International NV
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Turnhoutseweg 30, 2340 Beerse, België
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EU/1/14/945
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15.9.2026
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14.9.2026
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Lazcluze
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Janssen-Cilag International NV
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Turnhoutseweg 30, 2340 Beerse, België
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EU/1/24/1886
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15.9.2026
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14.9.2026
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Miglustat Dipharma
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Dipharma Arzneimittel GmbH
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Offheimer Weg 33, 65549 Limburg a. d. Lahn, Deutschland
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EU/1/18/1346
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18.9.2026
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14.9.2026
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Pergoveris
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Merck Europe B.V.
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Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland
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EU/1/07/396
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16.9.2026
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|
14.9.2026
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Skytrofa
|
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Ascendis Pharma Endocrinology Division A/S
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Tuborg Boulevard 12, 2900 Hellerup, Danmark
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EU/1/21/1607
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16.9.2026
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14.9.2026
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Steqeyma
|
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Celltrion Healthcare Hungary Kft.
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Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
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EU/1/24/1844
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24.8.2026
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14.9.2026
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Steqeyma
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Celltrion Healthcare Hungary Kft.
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Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
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EU/1/24/1844
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17.9.2026
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14.9.2026
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Sugammadex Adroiq
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Extrovis EU Kft.
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Raktarvarosi Ut 9, Torokbalint, 2045, Magyarország
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EU/1/23/1733
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16.9.2026
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14.9.2026
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Tasmar
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Viatris Healthcare Limited
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Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
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EU/1/97/044
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15.9.2026
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|
14.9.2026
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Tepmetko
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|
Merck Europe B.V.
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Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland
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EU/1/21/1596
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16.9.2026
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14.9.2026
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Xaluprine
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Lipomed GmbH
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Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland
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EU/1/11/727
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15.9.2026
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14.9.2026
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Zyprexa
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CHEPLAPHARM Registration GmbH
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Weiler Straße 5e, 79540 Lörrach, Deutschland
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EU/1/96/022
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17.9.2026
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|
17.9.2026
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Afqlir
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Sandoz GmbH
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Biochemiestrasse 10, 6250 Kundl, Österreich
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EU/1/24/1867
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2.10.2026
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18.9.2026
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Afiveg
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STADA Arzneimittel AG
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Stadastrasse 2-18, 61118 Bad Vilbel, Deutschland
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EU/1/25/1965
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24.9.2026
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18.9.2026
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Ahzantive
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Formycon AG
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82152 Martinsried/Planegg, Deutschland
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EU/1/24/1888
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21.9.2026
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18.9.2026
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BLINCYTO
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Amgen Europe B.V.
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Minervum 7061, 4817 ZK Breda, Nederland
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EU/1/15/1047
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21.9.2026
|
|
18.9.2026
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Bysumlog
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Sandoz GmbH
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Biochemiestrasse 10, 6250 Kundl, Österreich
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EU/1/26/2030
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21.9.2026
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18.9.2026
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Ebvallo
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Pierre Fabre Medicament
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Les Cauquillous, 81500 Lavaur, France
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EU/1/22/1700
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22.9.2026
|
|
18.9.2026
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Eiyzey
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Zakłady Farmaceutyczne POLPHARMA S.A.
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ul. Pelplińska 19, 83-200 Starogard Gdański, Polska
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EU/1/25/1963
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21.9.2026
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18.9.2026
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Enerzair Breezhaler
|
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Novartis Europharm Limited
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Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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EU/1/20/1438
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22.9.2026
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|
18.9.2026
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Eydenzelt
|
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Celltrion Healthcare Hungary Kft.
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Váci út 1-3. WestEnd Office Building B torony, 1062 Budapest, Magyarország
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EU/1/24/1895
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29.9.2026
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18.9.2026
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Eylea
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Bayer AG
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D-51368 Leverkusen, Deutschland
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EU/1/12/797
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21.9.2026
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18.9.2026
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Eyluxvi
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Biolitec Pharma Limited Zweigniederlassung Jena
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Otto-Schott-Str. 15, 07745 Jena, Deutschland
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EU/1/25/1972
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29.9.2026
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18.9.2026
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FABHALTA
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Novartis Europharm Limited
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Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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EU/1/24/1802
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22.9.2026
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18.9.2026
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Glyxambi
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Boehringer Ingelheim International GmbH
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Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland
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EU/1/16/1146
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22.9.2026
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18.9.2026
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Hirobriz Breezhaler
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Novartis Europharm Limited
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Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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EU/1/09/594
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22.9.2026
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|
18.9.2026
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Hyftor
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Plusultra pharma GmbH
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Fritz-Vomfelde-Str. 36, 40547 Düsseldorf, Deutschland
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EU/1/23/1723
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21.9.2026
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18.9.2026
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Idacio
|
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Fresenius Kabi Deutschland GmbH
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|
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland
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EU/1/19/1356
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23.9.2026
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18.9.2026
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Jentadueto
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Boehringer Ingelheim International GmbH
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Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland
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EU/1/12/780
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22.9.2026
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18.9.2026
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Kaftrio
|
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Vertex Pharmaceuticals (Ireland) Limited
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Unit 49, Block 5, Northwood Court, Northwood Crescent, Dublin 9, D09 T665, Ireland
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EU/1/20/1468
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21.9.2026
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18.9.2026
|
Litfulo
|
|
Pfizer Europe MA EEIG
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|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
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EU/1/23/1755
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21.9.2026
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18.9.2026
|
Lunsumio
|
|
Roche Registration GmbH
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|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
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EU/1/22/1649
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21.9.2026
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|
18.9.2026
|
Mylotarg
|
|
Pfizer Europe MA EEIG
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|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
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EU/1/18/1277
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21.9.2026
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|
18.9.2026
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MYNZEPLI
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|
Advanz Pharma Limited
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|
Unit 17, Northwood House, Northwood Crescent, Dublin 9, D09 V504, Ireland
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EU/1/25/1964
|
21.9.2026
|
|
18.9.2026
|
NULIBRY
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Integral Pharma Solutions EU Limited
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|
1 Windmill Lane, Dublin 2, Co. Dublin, D02 F206, Ireland
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EU/1/22/1684
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21.9.2026
|
|
18.9.2026
|
Omnitrope
|
|
Sandoz GmbH
|
|
Biochemiestrasse 10, 6250 Kundl, Österreich
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EU/1/06/332
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21.9.2026
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|
18.9.2026
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Opuviz
|
|
Samsung Bioepis NL B.V.
|
|
Olof Palmestraat 10, 2616 LR Delft, Nederland
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|
EU/1/24/1865
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22.9.2026
|
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18.9.2026
|
Otulfi
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Fresenius Kabi Deutschland GmbH
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|
Else-Kröner-Straße 1, 61352 Bad Homburg vor der Höhe, Deutschland
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|
EU/1/24/1863
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23.9.2026
|
|
18.9.2026
|
PAVBLU
|
|
Amgen Technology (Ireland) UC
|
|
Pottery Road, Dun Laoghaire, Co. Dublin, A96 F2A8, Ireland
|
|
EU/1/25/1909
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21.9.2026
|
|
18.9.2026
|
Plavix
|
|
Sanofi Winthrop Industrie
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|
82 avenue Raspail, 94250 Gentilly, France
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EU/1/98/069
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21.9.2026
|
|
18.9.2026
|
Replagal
|
|
Takeda Pharmaceuticals International AG Ireland Branch
|
|
Block 2, Miesian Plaza, 50-58 Baggot Street Lower, Dublin 2, D02 HW68, Ireland
|
|
EU/1/01/189
|
21.9.2026
|
|
18.9.2026
|
Riltrava Aerosphere
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
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|
EU/1/21/1604
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21.9.2026
|
|
18.9.2026
|
RINVOQ
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|
AbbVie Deutschland GmbH & Co. KG
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|
Knollstrasse, 67061 Ludwigshafen, Deutschland
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EU/1/19/1404
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21.9.2026
|
|
18.9.2026
|
Rivaroxaban Viatris
|
|
Viatris Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
|
|
EU/1/21/1588
|
22.9.2026
|
|
18.9.2026
|
Roteas
|
|
Berlin-Chemie AG
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|
Glienicker Weg 125, 12489 Berlin, Deutschland
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EU/1/16/1152
|
21.9.2026
|
|
18.9.2026
|
Svariya
|
|
PGF Pharma International d.o.o.
|
|
Ulica Roberta Frangeša Mihanovića 9, 10110 Zagreb, Hrvatska
|
|
EU/1/25/1994
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21.9.2026
|
|
18.9.2026
|
Tevimbra
|
|
BeOne Medicines Ireland Limited
|
|
10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
|
|
EU/1/23/1758
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22.9.2026
|
|
18.9.2026
|
Tolucombi
|
|
KRKA d d., Novo mesto
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|
Šmarješka cesta 6, 8501 Novo mesto, Slovenija
|
|
EU/1/13/821
|
21.9.2026
|
|
18.9.2026
|
TRIXEO AEROSPHERE
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/20/1498
|
21.9.2026
|
|
18.9.2026
|
Vyepti
|
|
H. Lundbeck A/S
|
|
Ottiliavej 9, 2500 Valby, Danmark
|
|
EU/1/21/1599
|
22.9.2026
|
|
18.9.2026
|
Yesafili
|
|
Biosimilar Collaborations Ireland Limited
|
|
Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland
|
|
EU/1/23/1751
|
23.9.2026
|
|
21.9.2026
|
Cejemly
|
|
CStone Pharmaceuticals Ireland Limited
|
|
117-126 Sheriff Street Upper Dublin 1, D01 YC43, Ireland
|
|
EU/1/24/1833
|
28.9.2026
|
|
21.9.2026
|
Daptomycin Hospira
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/17/1175
|
23.9.2026
|
|
21.9.2026
|
ELREXFIO
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/23/1770
|
22.9.2026
|
|
21.9.2026
|
Padcev
|
|
Astellas Pharma Europe B.V.
|
|
Sylviusweg 62, 2333 BE Leiden, Nederland
|
|
EU/1/21/1615
|
22.9.2026
|
|
21.9.2026
|
Svariya
|
|
PGF Pharma International d.o.o.
|
|
Ulica Roberta Frangeša Mihanovića 9, 10110 Zagreb, Hrvatska
|
|
EU/1/25/1994
|
22.9.2026
|
|
21.9.2026
|
Wegovy
|
|
Novo Nordisk A/S
|
|
Novo Allé, 2880 Bagsvaerd, Danmark
|
|
EU/1/21/1608
|
24.9.2026
|
|
25.9.2026
|
Briumvi
|
|
Neuraxpharm Pharmaceuticals, S.L.
|
|
Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, España
|
|
EU/1/23/1730
|
6.10.2026
|
|
25.9.2026
|
Champix
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/06/360
|
28.9.2026
|
|
25.9.2026
|
Humira
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/03/256
|
28.9.2026
|
|
25.9.2026
|
Imlygic
|
|
Amgen Europe B.V.
|
|
Minervum 7061, 4817 ZK Breda, Nederland
|
|
EU/1/15/1064
|
28.9.2026
|
|
25.9.2026
|
Lacosamide Adroiq
|
|
Extrovis EU Kft.
|
|
Raktarvarosi Ut 9, Torokbalint, 2045, Magyarország
|
|
EU/1/23/1732
|
2.10.2026
|
|
25.9.2026
|
Ozurdex
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/10/638
|
28.9.2026
|
|
25.9.2026
|
RIULVY
|
|
Neuraxpharm Pharmaceuticals, S.L.
|
|
Avda. Barcelona 69, 08970 Sant Joan Despí - Barcelona, España
|
|
EU/1/25/1947
|
6.10.2026
|
|
25.9.2026
|
Sialanar
|
|
Proveca Pharma Limited
|
|
2 Dublin Landings, North Wall Quay, Dublin 1, Ireland
|
|
EU/1/16/1135
|
14.10.2026
|
|
25.9.2026
|
Usymro
|
|
Gedeon Richter Plc.
|
|
Gyömrői út 19-21, 1103 Budapest, Magyarország
|
|
EU/1/25/1957
|
28.9.2026
|
|
25.9.2026
|
Vaxelis
|
|
MCM Vaccine B.V.
|
|
Robert Boyleweg 4, 2333 CG Leiden, Nederland
|
|
EU/1/15/1079
|
5.10.2026
|
|
25.9.2026
|
Vizamyl
|
|
GE Healthcare AS
|
|
Nycoveien 1, 0485, Oslo, Norge
|
|
EU/1/14/941
|
9.10.2026
|
|
25.9.2026
|
ZINPLAVA
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
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EU/1/16/1156
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28.9.2026
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28.9.2026
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Baiama
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Formycon AG
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Fraunhoferstraße 15, 82152 Martinsried/Planegg, Deutschland
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EU/1/24/1887
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29.9.2026
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28.9.2026
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Cegfila
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Mundipharma Corporation (Ireland) Limited
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United Drug House Magna Drive, Magna Business Park, Citywest Road, Dublin 24, Ireland
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EU/1/19/1409
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29.9.2026
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29.9.2026
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Nexviadyme
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Sanofi B.V.
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Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
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EU/1/21/1579
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6.10.2026
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