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Data wydania decyzji
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Nazwa produktu leczniczego
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Posiadacz pozwolenia na dopuszczenie do obrotu
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Numer pozycji w rejestrze wspólnotowym
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Data notyfikacji
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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.
|
|
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.
|
|
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
|
|
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
|
|
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
|
|
22.8.2024
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Betmiga
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|
Astellas Pharma Europe B.V.
|
|
Sylviusweg 62, 2333 BE Leiden, Nederland
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|
EU/1/12/809
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27.8.2024
|
|
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
|
|
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
|
|
EU/1/19/1395
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23.8.2024
|
|
22.8.2024
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Copiktra
|
|
Secura Bio Limited
|
|
32 Molesworth Street, Dublin 2 D02 Y512, Co. Dublin, Ireland
|
|
EU/1/21/1542
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29.8.2024
|
|
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
|
|
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
|
|
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
|
|
EU/1/14/945
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23.8.2024
|
|
22.8.2024
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Instanyl
|
|
Istituto Gentili S.r.l.
|
|
Via San Giuseppe Cottolengo 15, 20143 Milano, Italia
|
|
EU/1/09/531
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27.8.2024
|
|
22.8.2024
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Jylamvo
|
|
Oresund Pharma ApS
|
|
Orient Plads 1, 2150 Nordhavn, Danmark
|
|
EU/1/17/1172
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23.8.2024
|
|
22.8.2024
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Jyseleca
|
|
Alfasigma S.p.A.
|
|
Via Ragazzi del '99, n.5, 40133 Bologna, Italia
|
|
EU/1/20/1480
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28.8.2024
|
|
22.8.2024
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Mounjaro
|
|
Eli Lilly Nederland B.V.
|
|
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
|
EU/1/22/1685
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26.8.2024
|
|
22.8.2024
|
Quofenix
|
|
A. Menarini - Industrie Farmaceutiche Riunite - s.r.l.
|
|
Via Sette Santi 3, 50131 Florence, Italia
|
|
EU/1/19/1393
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27.8.2024
|
|
22.8.2024
|
Rybrevant
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/21/1594
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23.8.2024
|
|
22.8.2024
|
Savene
|
|
CNX Therapeutics Ireland Limited
|
|
5th Floor Rear, Connaught House, 1 Burlington Road, Dublin 4, Ireland
|
|
EU/1/06/350
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23.8.2024
|
|
22.8.2024
|
Signifor
|
|
Recordati Rare Diseases
|
|
Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France
|
|
EU/1/12/753
|
26.8.2024
|
|
22.8.2024
|
Spravato
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/19/1410
|
23.8.2024
|
|
22.8.2024
|
Suliqua
|
|
Sanofi Winthrop Industrie
|
|
82 avenue Raspail, 94250 Gentilly, France
|
|
EU/1/16/1157
|
23.8.2024
|
|
22.8.2024
|
XALKORI
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/12/793
|
23.8.2024
|
|
26.8.2024
|
Arexvy
|
|
GlaxoSmithKline Biologicals S.A.
|
|
rue de l'Institut 89, 1330 Rixensart, Belgique
|
|
EU/1/23/1740
|
27.8.2024
|
|
26.8.2024
|
Padcev
|
|
Astellas Pharma Europe B.V.
|
|
Sylviusweg 62, 2333 BE Leiden, Nederland
|
|
EU/1/21/1615
|
27.8.2024
|
|
26.8.2024
|
Slenyto
|
|
RAD Neurim Pharmaceuticals EEC SARL
|
|
4 rue de Marivaux, 75002 Paris, France
|
|
EU/1/18/1318
|
28.8.2024
|
|
26.8.2024
|
Tecentriq
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/17/1220
|
27.8.2024
|
|
29.8.2024
|
Abiraterone Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/20/1512
|
30.8.2024
|
|
29.8.2024
|
Braftovi
|
|
Pierre Fabre Médicament
|
|
Les Cauquillous, 81500 Lavaur, France
|
|
EU/1/18/1314
|
3.9.2024
|
|
29.8.2024
|
Ilaris
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/09/564
|
30.8.2024
|
|
29.8.2024
|
KEYTRUDA
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/15/1024
|
30.8.2024
|
|
29.8.2024
|
Mektovi
|
|
Pierre Fabre Médicament
|
|
Les Cauquillous, 81500 Lavaur, France
|
|
EU/1/18/1315
|
3.9.2024
|
|
29.8.2024
|
Opfolda
|
|
Amicus Therapeutics Europe Limited
|
|
Block 1, Blanchardstown Corporate Park, Ballycoolin Road, Blanchardstown, Dublin D15 AKK1, Ireland
|
|
EU/1/23/1737
|
30.8.2024
|
|
29.8.2024
|
Rixathon
|
|
Sandoz GmbH
|
|
Biochemiestrasse 10, 6250 Kundl, Österreich
|
|
EU/1/17/1185
|
30.8.2024
|
|
29.8.2024
|
Vyvgart
|
|
argenx BV
|
|
Industriepark-Zwijnaarde 7, 9052 Gent, België
|
|
EU/1/22/1674
|
30.8.2024
|
|
29.8.2024
|
Xigduo
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/13/900
|
30.8.2024
|
|
30.8.2024
|
ADYNOVI
|
|
Baxalta Innovations GmbH
|
|
Industriestraße 67, 1221 Wien, Österreich
|
|
EU/1/17/1247
|
3.9.2024
|
|
30.8.2024
|
ASPAVELI
|
|
Swedish Orphan Biovitrum AB (publ)
|
|
112 76 Stockholm, Sverige
|
|
EU/1/21/1595
|
2.9.2024
|
|
30.8.2024
|
Nordimet
|
|
Nordic Group B.V.
|
|
Siriusdreef 41, 2132 WT Hoofddorp, Nederland
|
|
EU/1/16/1124
|
2.9.2024
|
|
30.8.2024
|
Riltrava Aerosphere
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/21/1604
|
2.9.2024
|
