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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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1.8.2024
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Arava
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Sanofi-Aventis Deutschland GmbH
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D-65926 Frankfurt am Main, Deutschland
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EU/1/99/118
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6.8.2024
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1.8.2024
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Beyfortus
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Sanofi Winthrop Industrie
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82 avenue Raspail, 94250 Gentilly, France
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EU/1/22/1689
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2.8.2024
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1.8.2024
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Bimzelx
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UCB Pharma S.A.
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Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België
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EU/1/21/1575
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5.8.2024
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1.8.2024
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Edistride
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AstraZeneca AB
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151 85 Södertälje, Sverige
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EU/1/15/1052
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2.8.2024
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1.8.2024
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Infanrix hexa
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GlaxoSmithKline Biologicals S.A.
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rue de l'Institut 89, 1330 Rixensart, Belgique
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EU/1/00/152
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6.8.2024
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1.8.2024
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Noxafil
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Merck Sharp & Dohme B.V.
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Waarderweg 39, 2031 BN Haarlem, Nederland
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EU/1/05/320
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2.8.2024
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1.8.2024
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Reagila
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Gedeon Richter Plc.
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Gyömrői út 19-21, 1103 Budapest, Magyarország
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EU/1/17/1209
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15.8.2024
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1.8.2024
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Rybelsus
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Novo Nordisk A/S
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Novo Allé, 2880 Bagsvaerd, Danmark
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EU/1/20/1430
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5.8.2024
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1.8.2024
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Vosevi
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Gilead Sciences Ireland UC
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Carrigtohill, County Cork, T45 DP77, Ireland
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EU/1/17/1223
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6.8.2024
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5.8.2024
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ADVATE
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Takeda Manufacturing Austria AG
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Industriestraße 67, 1221 Wien, Österreich
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EU/1/03/271
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6.8.2024
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5.8.2024
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CAMZYOS
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Bristol Myers Squibb Pharma EEIG
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Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
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EU/1/23/1716
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6.8.2024
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5.8.2024
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Dabigatran Etexilate 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/1/22/1665
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12.8.2024
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5.8.2024
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Dapagliflozin Viatris
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Viatris Limited
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Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
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EU/1/23/1721
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6.8.2024
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5.8.2024
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Filsuvez
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Chiesi Farmaceutici S.p.A.
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Via Palermo 26/A, 43122 Parma, Italia
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EU/1/22/1652
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8.8.2024
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5.8.2024
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Fotivda
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Recordati Netherlands B.V.
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Beechavenue 54, 1119PW Schiphol-Rijk, Nederland
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EU/1/17/1215
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13.8.2024
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5.8.2024
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Lojuxta
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Chiesi Farmaceutici S.p.A.
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Via Palermo 26/A, 43122 Parma, Italia
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EU/1/13/851
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8.8.2024
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5.8.2024
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Pegasys
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pharmaand GmbH
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Taborstrasse 1, 1020 Wien, Österreich
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EU/1/02/221
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6.8.2024
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5.8.2024
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Skyclarys
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Biogen Netherlands B.V.
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Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
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EU/1/23/1786
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6.8.2024
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5.8.2024
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Vyndaqel
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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/1/11/717
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6.8.2024
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9.8.2024
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Actos
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CHEPLAPHARM Arzneimittel GmbH
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Ziegelhof 24, 17489 Greifswald, Deutschland
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EU/1/00/150
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21.8.2024
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9.8.2024
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Forxiga
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AstraZeneca AB
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151 85 Södertälje, Sverige
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EU/1/12/795
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12.8.2024
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9.8.2024
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Xarelto
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Bayer AG
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D-51368 Leverkusen, Deutschland
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EU/1/08/472
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12.8.2024
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12.8.2024
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Hefiya
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Sandoz GmbH
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Biochemiestrasse 10, 6250 Kundl, Österreich
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EU/1/18/1287
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13.8.2024
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12.8.2024
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Lynparza
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AstraZeneca AB
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151 85 Södertälje, Sverige
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EU/1/14/959
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13.8.2024
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12.8.2024
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TRIXEO AEROSPHERE
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AstraZeneca AB
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151 85 Södertälje, Sverige
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EU/1/20/1498
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13.8.2024
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12.8.2024
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Zypadhera
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CHEPLAPHARM Registration GmbH
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Weiler Straße 5e, 79540 Lörrach, Deutschland
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EU/1/08/479
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14.8.2024
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16.8.2024
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Abrysvo
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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/1/23/1752
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19.8.2024
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16.8.2024
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Competact
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CHEPLAPHARM Arzneimittel GmbH
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Ziegelhof 24, 17489 Greifswald, Deutschland
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EU/1/06/354
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9.9.2024
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16.8.2024
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Jaypirca
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Eli Lilly Nederland B.V.
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Papendorpseweg 83, 3528 BJ Utrecht, Nederland
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EU/1/23/1738
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19.8.2024
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16.8.2024
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Ninlaro
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Takeda Pharma A/S
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Delta Park 45, 2665 Vallensbaek Strand, Danmark
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EU/1/16/1094
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19.8.2024
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16.8.2024
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Roctavian
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BioMarin International Limited
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Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland
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EU/1/22/1668
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22.8.2024
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16.8.2024
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Spinraza
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Biogen Netherlands B.V.
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Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
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EU/1/17/1188
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19.8.2024
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16.8.2024
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Tepkinly
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AbbVie Deutschland GmbH & Co. KG
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Knollstrasse, 67061 Ludwigshafen, Deutschland
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EU/1/23/1759
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19.8.2024
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22.8.2024
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Baqsimi
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Amphastar France Pharmaceuticals
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Usine Saint Charles, Eragny Sur Epte, 60590 France
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EU/1/19/1406
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23.8.2024
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22.8.2024
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Betmiga
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Astellas Pharma Europe B.V.
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Sylviusweg 62, 2333 BE Leiden, Nederland
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EU/1/12/809
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27.8.2024
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22.8.2024
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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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23.8.2024
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22.8.2024
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Clopidogrel/Acetylsalicylic acid Viatris
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Viatris Limited
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Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
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EU/1/19/1395
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23.8.2024
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22.8.2024
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Copiktra
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Secura Bio Limited
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32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland
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EU/1/21/1542
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29.8.2024
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22.8.2024
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Cresemba
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Basilea Pharmaceutica Deutschland GmbH
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Marie-Curie-Strasse 8, 79539 Loerrach, Deutschland
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EU/1/15/1036
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23.8.2024
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22.8.2024
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Evenity
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UCB Pharma S.A.
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Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België
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EU/1/19/1411
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26.8.2024
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22.8.2024
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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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23.8.2024
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22.8.2024
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Instanyl
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Istituto Gentili S.r.l.
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Via San Giuseppe Cottolengo 15, 20143 Milano, Italia
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EU/1/09/531
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27.8.2024
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22.8.2024
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Jylamvo
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Oresund Pharma ApS
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Orient Plads 1, 2150 Nordhavn, Danmark
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EU/1/17/1172
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23.8.2024
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22.8.2024
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Jyseleca
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Alfasigma S.p.A.
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Via Ragazzi del '99, n.5, 40133 Bologna, Italia
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EU/1/20/1480
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28.8.2024
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22.8.2024
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Mounjaro
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Eli Lilly Nederland B.V.
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Papendorpseweg 83, 3528 BJ Utrecht, Nederland
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EU/1/22/1685
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26.8.2024
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22.8.2024
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Quofenix
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A. Menarini - Industrie Farmaceutiche Riunite - s.r.l.
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Via Sette Santi 3, 50131 Florence, Italia
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EU/1/19/1393
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27.8.2024
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22.8.2024
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Rybrevant
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Janssen-Cilag International NV
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Turnhoutseweg 30, 2340 Beerse, België
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EU/1/21/1594
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23.8.2024
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22.8.2024
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Savene
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CNX Therapeutics Ireland Limited
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5th Floor Rear, Connaught House, 1 Burlington Road, Dublin 4, Ireland
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EU/1/06/350
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23.8.2024
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22.8.2024
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Signifor
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Recordati Rare Diseases
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Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92800 Puteaux, France
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EU/1/12/753
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26.8.2024
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22.8.2024
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Spravato
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Janssen-Cilag International NV
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Turnhoutseweg 30, 2340 Beerse, België
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EU/1/19/1410
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23.8.2024
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22.8.2024
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Suliqua
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Sanofi Winthrop Industrie
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82 avenue Raspail, 94250 Gentilly, France
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EU/1/16/1157
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23.8.2024
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22.8.2024
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XALKORI
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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/1/12/793
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23.8.2024
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26.8.2024
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Arexvy
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GlaxoSmithKline Biologicals S.A.
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rue de l'Institut 89, 1330 Rixensart, Belgique
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EU/1/23/1740
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27.8.2024
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26.8.2024
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Padcev
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Astellas Pharma Europe B.V.
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Sylviusweg 62, 2333 BE Leiden, Nederland
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EU/1/21/1615
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27.8.2024
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26.8.2024
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Slenyto
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RAD Neurim Pharmaceuticals EEC SARL
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4 rue de Marivaux, 75002 Paris, France
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EU/1/18/1318
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28.8.2024
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26.8.2024
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Tecentriq
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Roche Registration GmbH
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Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
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EU/1/17/1220
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27.8.2024
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29.8.2024
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Abiraterone 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/1/20/1512
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30.8.2024
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29.8.2024
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Braftovi
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Pierre Fabre Médicament
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Les Cauquillous, 81500 Lavaur, France
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EU/1/18/1314
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3.9.2024
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29.8.2024
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Ilaris
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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/1/09/564
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30.8.2024
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29.8.2024
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KEYTRUDA
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Merck Sharp & Dohme B.V.
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Waarderweg 39, 2031 BN Haarlem, Nederland
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EU/1/15/1024
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30.8.2024
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29.8.2024
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Mektovi
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Pierre Fabre Médicament
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Les Cauquillous, 81500 Lavaur, France
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EU/1/18/1315
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3.9.2024
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29.8.2024
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Opfolda
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Amicus Therapeutics Europe Limited
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Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland
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EU/1/23/1737
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30.8.2024
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29.8.2024
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Rixathon
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Sandoz GmbH
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Biochemiestrasse 10, 6250 Kundl, Österreich
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EU/1/17/1185
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30.8.2024
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29.8.2024
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Vyvgart
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argenx BV
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Industriepark-Zwijnaarde 7, 9052 Gent, België
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EU/1/22/1674
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30.8.2024
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29.8.2024
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Xigduo
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AstraZeneca AB
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151 85 Södertälje, Sverige
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EU/1/13/900
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30.8.2024
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30.8.2024
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ADYNOVI
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Baxalta Innovations GmbH
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Industriestraße 67, 1221 Wien, Österreich
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EU/1/17/1247
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3.9.2024
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30.8.2024
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ASPAVELI
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Swedish Orphan Biovitrum AB (publ)
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112 76 Stockholm, Sverige
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EU/1/21/1595
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2.9.2024
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30.8.2024
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Nordimet
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Nordic Group B.V.
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Siriusdreef 41, 2132 WT Hoofddorp, Nederland
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EU/1/16/1124
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2.9.2024
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30.8.2024
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Riltrava Aerosphere
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AstraZeneca AB
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151 85 Södertälje, Sverige
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EU/1/21/1604
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2.9.2024
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