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Modifika ta' awtorizzazzjoni għat-tqegħid fis-suq (Artikolu 13 tar-Regolament (KE) Nru 726/2004 tal-Parlament Ewropew u tal-Kunsill): Aċċettat
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Data tad-deċiżjoni
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Isem tal-prodott mediċinali
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Detentur tal-awtorizzazzjoni għat-tqegħid fis-suq
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Numru tal-entrata fir-Reġistru Komunitarju
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Data ta' notifika
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2.5.2025
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Bylvay
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Ipsen Pharma
65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
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EU/1/21/1566
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6.5.2025
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2.5.2025
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Calquence
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AstraZeneca AB
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151 85 Södertälje, Sverige
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EU/1/20/1479
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5.5.2025
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2.5.2025
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Calquence
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AstraZeneca AB
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151 85 Södertälje, Sverige
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EU/1/20/1479
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5.5.2025
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2.5.2025
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Clopidogrel Viatris
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Viatris Limited
Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
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EU/1/09/568
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5.5.2025
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2.5.2025
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ELREXFIO
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Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
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EU/1/23/1770
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5.5.2025
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2.5.2025
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Entresto
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Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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EU/1/15/1058
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6.5.2025
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2.5.2025
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EVOTAZ
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Bristol-Myers Squibb Pharma EEIG
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland
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EU/1/15/1025
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6.5.2025
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2.5.2025
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Fingolimod 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/1/20/1450
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13.5.2025
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2.5.2025
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Ongentys
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Bial - Portela & Ca, SA
À Av. da Siderurgia Nacional, 4745-457 S. Mamede do Coronado, Portugal
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EU/1/15/1066
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5.5.2025
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2.5.2025
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Paxlovid
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Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
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EU/1/22/1625
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5.5.2025
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2.5.2025
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Praluent
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Sanofi Winthrop Industrie
82 avenue Raspail, 94250 Gentilly, France
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EU/1/15/1031
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5.5.2025
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2.5.2025
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Spexotras
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Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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EU/1/23/1781
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6.5.2025
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2.5.2025
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TachoSil
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Corza Medical GmbH
Speditionstraße 21, 40221 Düsseldorf, Deutschland
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EU/1/04/277
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6.5.2025
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2.5.2025
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Tevimbra
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BeiGene Ireland Limited
10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
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EU/1/23/1758
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5.5.2025
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2.5.2025
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Tremfya
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Janssen-Cilag International NV
Turnhoutseweg 30, 2340 Beerse, België
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EU/1/17/1234
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5.5.2025
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2.5.2025
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Xydalba
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AbbVie Deutschland GmbH & Co. KG
Knollstrasse, 67061 Ludwigshafen, Deutschland
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EU/1/14/986
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5.5.2025
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8.5.2025
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Cystagon
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Recordati Rare Diseases
Tour Hekla, 52 avenue du Général de Gaulle, F-92800 Puteaux, France
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EU/1/97/039
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12.5.2025
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8.5.2025
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Esbriet
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Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
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EU/1/11/667
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12.5.2025
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8.5.2025
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Glyxambi
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Boehringer Ingelheim International GmbH
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland
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EU/1/16/1146
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15.5.2025
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8.5.2025
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Olumiant
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Eli Lilly Nederland B.V.
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
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EU/1/16/1170
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12.5.2025
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8.5.2025
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Pirfenidone axunio
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axunio Pharma GmbH
Van-der-Smissen-Straße 1, 22767 Hamburg, Deutschland
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EU/1/22/1655
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14.5.2025
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8.5.2025
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Prevenar 13
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Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
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EU/1/09/590
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12.5.2025
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8.5.2025
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RoActemra
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Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
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EU/1/08/492
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12.5.2025
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15.5.2025
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BEQVEZ
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Pfizer Europe MA EEIG
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
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EU/1/24/1838
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16.5.2025
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15.5.2025
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Korjuny
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Atnahs Pharma Netherlands B. V.
Copenhagen Towers, Ørestads Boulevard 108, 5.tv, DK-2300 København S, Danmark
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EU/1/24/1826
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21.5.2025
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15.5.2025
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Mabthera
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Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
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EU/1/98/067
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16.5.2025
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15.5.2025
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Onpattro
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Alnylam Netherlands B.V.
Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland
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EU/1/18/1320
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20.5.2025
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15.5.2025
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OPDIVO
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Bristol-Myers Squibb Pharma EEIG
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland
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EU/1/15/1014
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20.5.2025
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15.5.2025
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Sorafenib 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/1/22/1696
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19.5.2025
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15.5.2025
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Tysabri
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Biogen Netherlands B.V.
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
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EU/1/06/346
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16.5.2025
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15.5.2025
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Zilbrysq
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UCB Pharma S.A.
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België
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EU/1/23/1764
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20.5.2025
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16.5.2025
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IXCHIQ
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Valneva Austria GmbH
Campus Vienna Biocenter 3, 1030 Wien, Österreich
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EU/1/24/1828
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20.5.2025
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22.5.2025
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Breyanzi
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Bristol Myers Squibb Pharma EEIG
Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
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EU/1/22/1631
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23.5.2025
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22.5.2025
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Kaftrio
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Vertex Pharmaceuticals (Ireland) Limited
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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25.5.2025
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22.5.2025
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Kymriah
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Novartis Europharm Limited
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
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EU/1/18/1297
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23.5.2025
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22.5.2025
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Lumeblue
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Cosmo Technologies Ltd
Riverside II, Sir John Rogerson’s Quay, Dublin 2, Ireland
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EU/1/20/1470
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27.5.2025
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22.5.2025
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Mysimba
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Orexigen Therapeutics Ireland Limited
9-10 Fenian Street, Dublin 2, D02 RX24, Ireland
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EU/1/14/988
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23.5.2025
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22.5.2025
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Qtern
|
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AstraZeneca AB
|
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151 85 Södertälje, Sverige
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EU/1/16/1108
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23.5.2025
|
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22.5.2025
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Xromi
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Lipomed GmbH
Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland
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EU/1/19/1366
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26.5.2025
|
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26.5.2025
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OPDIVO
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Bristol-Myers Squibb Pharma EEIG
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland
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EU/1/15/1014
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28.5.2025
|
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26.5.2025
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Xofluza
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Roche Registration GmbH
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
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EU/1/20/1500
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27.5.2025
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