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—
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Izmjena odobrenja za stavljanje u promet (članak 13 Uredbe (EZ) br. 726/2004 Europskog parlamenta i Vijeća): Prihvaćeno
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Datum odluke
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Naziv lijeka
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Nositelj odobrenja za stavljanje u promet
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Broj upisa u registar Zajednice
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Datum obavijesti
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3.7.2024
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Comirnaty
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BioNTech Manufacturing GmbH
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An der Goldgrube 12, 55131 Mainz, Deutschland
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EU/1/20/1528
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4.7.2024
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5.7.2024
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Aldara
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Viatris Healthcare Limited
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Damastown Industrial Park, Mulhuddart, Dublin 15, Ireland
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EU/1/98/080
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8.7.2024
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5.7.2024
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Carbaglu
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Recordati Rare Diseases
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Immeuble Le Wilson, 70 avenue du Général de Gaulle, 92 800 Puteaux, France
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EU/1/02/246
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10.7.2024
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5.7.2024
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Cosentyx
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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/1/14/980
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8.7.2024
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5.7.2024
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Darunavir Viatris
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Viatris Limited
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Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
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EU/1/16/1140
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8.7.2024
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5.7.2024
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Inrebic
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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/1/20/1514
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8.7.2024
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5.7.2024
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Iressa
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AstraZeneca AB
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151 85 Södertälje, Sverige
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EU/1/09/526
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8.7.2024
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5.7.2024
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Jylamvo
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Oresund Pharma ApS
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Orient Plads 1, 2150 Nordhavn, Hovedstaden, Danmark
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EU/1/17/1172
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8.7.2024
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5.7.2024
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Lonquex
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Teva B.V.
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Swensweg 5, 2031 GA Haarlem, Nederland
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EU/1/13/856
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8.7.2024
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5.7.2024
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Neulasta
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Amgen Europe B.V.
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Minervum 7061, 4817 ZK Breda, Nederland
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EU/1/02/227
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8.7.2024
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5.7.2024
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NovoMix
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Novo Nordisk A/S
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Novo Allé, 2880 Bagsvaerd, Danmark
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EU/1/00/142
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8.7.2024
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5.7.2024
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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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8.7.2024
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5.7.2024
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Ristaben
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Merck Sharp & Dohme B.V.
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Waarderweg 39, 2031 BN Haarlem, Nederland
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EU/1/10/621
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9.7.2024
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5.7.2024
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Ronapreve
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Roche Registration GmbH
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Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
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EU/1/21/1601
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8.7.2024
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5.7.2024
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Saxenda
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Novo Nordisk A/S
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Novo Allé, 2880 Bagsvaerd, Danmark
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EU/1/15/992
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8.7.2024
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5.7.2024
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Sibnayal
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ADVICENNE
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262, rue du Faubourg Saint Honoré 75008 Paris, France
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EU/1/20/1517
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8.7.2024
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5.7.2024
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Temozolomide 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/1/10/615
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8.7.2024
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5.7.2024
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Tigecycline 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/1/19/1394
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8.7.2024
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5.7.2024
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TUKYSA
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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/1/20/1526
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11.7.2024
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5.7.2024
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ZTALMY
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Marinus Pharmaceuticals Emerald Limited
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10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
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EU/1/23/1743
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10.7.2024
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8.7.2024
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Sugammadex Amomed
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AOP Orphan Pharmaceuticals GmbH
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Leopold-Ungar-Platz 2, 1190 Wien, Österreich
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EU/1/22/1708
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11.7.2024
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8.7.2024
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Tevimbra
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BeiGene Ireland Limited
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10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
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EU/1/23/1758
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9.7.2024
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8.7.2024
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Victoza
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Novo Nordisk A/S
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Novo Allé, 2880 Bagsvaerd, Danmark
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EU/1/09/529
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9.7.2024
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12.7.2024
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Ocaliva
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ADVANZ PHARMA Limited
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Suite 17, Northwood House, Northwood Avenue, Santry, Dublin 9, Ireland
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EU/1/16/1139
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15.7.2024
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12.7.2024
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Ristfor
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Merck Sharp & Dohme B.V.
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Waarderweg 39, 2031 BN Haarlem, Nederland
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EU/1/10/620
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16.7.2024
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12.7.2024
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Soliris
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Alexion Europe SAS
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103-105 rue Anatole France, 92300 Levallois-Perret, France
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EU/1/07/393
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15.7.2024
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17.7.2024
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Accofil
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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/1/14/946
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18.7.2024
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17.7.2024
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Fluenz
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AstraZeneca AB
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151 85 Södertälje, Sverige
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EU/1/24/1816
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18.7.2024
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17.7.2024
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Galvus
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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/1/07/414
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18.7.2024
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17.7.2024
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GAVRETO
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Blueprint Medicines (Netherlands) B.V.
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Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland
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EU/1/21/1555
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18.7.2024
|
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17.7.2024
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Minjuvi
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Incyte Biosciences Distribution B.V.
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Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
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EU/1/21/1570
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18.7.2024
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17.7.2024
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Rekovelle
|
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Ferring Pharmaceuticals A/S
|
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Amager Strandvej 405, 2770 Kastrup, Danmark
|
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EU/1/16/1150
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23.7.2024
|
|
17.7.2024
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Ritonavir Viatris
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Viatris Limited
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Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
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EU/1/17/1242
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18.7.2024
|
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17.7.2024
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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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18.7.2024
|
|
18.7.2024
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Levetiracetam SUN
|
|
Sun Pharmaceutical Industries Europe BV
|
|
Polarisavenue 87, 2132 JH Hoofddorp, Nederland
|
|
EU/1/11/741
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25.7.2024
|
|
18.7.2024
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Retacrit
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/07/431
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18.7.2024
|
|
19.7.2024
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Hyrimoz
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Sandoz GmbH
|
|
Biochemiestrasse 10, 6250 Kundl, Österreich
|
|
EU/1/18/1286
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22.7.2024
|
|
19.7.2024
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Piqray
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/20/1455
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22.7.2024
|
|
19.7.2024
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Pregabalin Viatris
|
|
Viatris Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/15/997
|
24.7.2024
|
|
19.7.2024
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Scemblix
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/22/1670
|
22.7.2024
|
|
19.7.2024
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Votrient
|
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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/1/10/628
|
22.7.2024
|
|
22.7.2024
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Avonex
|
|
Biogen Netherlands B.V.
|
|
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
|
|
EU/1/97/033
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23.7.2024
|
|
22.7.2024
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Byfavo
|
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PAION Pharma GmbH
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Heussstraße 25, 52078 Aachen, Deutschland
|
|
EU/1/20/1505
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25.7.2024
|
|
22.7.2024
|
Deferasirox Mylan
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/19/1386
|
23.7.2024
|
|
22.7.2024
|
Norvir
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/96/016
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23.7.2024
|
|
22.7.2024
|
Slenyto
|
|
RAD Neurim Pharmaceuticals EEC SARL
|
|
4 rue de Marivaux, 75002 Paris, France
|
|
EU/1/18/1318
|
25.7.2024
|
|
22.7.2024
|
Teriflunomide Mylan
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/22/1698
|
23.7.2024
|
|
22.7.2024
|
VITRAKVI
|
|
Bayer AG
|
|
D-51368 Leverkusen, Deutschland
|
|
EU/1/19/1385
|
23.7.2024
|
|
23.7.2024
|
Prometax
|
|
Almirall, S.A.
|
|
Ronda General Mitre, 151, 08022 Barcelona, España
|
|
EU/1/98/092
|
25.7.2024
|
|
24.7.2024
|
AUBAGIO
|
|
Sanofi Winthrop Industrie
|
|
82 avenue Raspail, 94250 Gentilly, France
|
|
EU/1/13/838
|
25.7.2024
|
|
24.7.2024
|
Buvidal
|
|
Camurus AB
|
|
Ideon Science Park, 223 70 Lund, Sverige
|
|
EU/1/18/1336
|
25.7.2024
|
|
24.7.2024
|
Bydureon
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/11/696
|
25.7.2024
|
|
24.7.2024
|
Bylvay
|
|
Ipsen Pharma
|
|
65 quai Georges Gorse, 92100 Boulogne-Billancourt, France
|
|
EU/1/21/1566
|
29.7.2024
|
|
24.7.2024
|
Caprelsa
|
|
Sanofi B.V.
|
|
Paasheuvelweg 25, 1105 BP Amsterdam, Nederland
|
|
EU/1/11/749
|
25.7.2024
|
|
24.7.2024
|
Fluad Tetra
|
|
Seqirus Netherlands B.V.
|
|
Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland
|
|
EU/1/20/1433
|
25.7.2024
|
|
24.7.2024
|
Flucelvax Tetra
|
|
Seqirus Netherlands B.V.
|
|
Paasheuvelweg 28, 1105 BJ Amsterdam, Nederland
|
|
EU/1/18/1326
|
25.7.2024
|
|
24.7.2024
|
Idefirix
|
|
Hansa Biopharma AB
|
|
P.O. Box 785, 220 07 Lund, Sverige
|
|
EU/1/20/1471
|
25.7.2024
|
|
24.7.2024
|
Ilumetri
|
|
Almirall, S.A.
|
|
Ronda General Mitre, 151, 08022 Barcelona, España
|
|
EU/1/18/1323
|
29.7.2024
|
|
24.7.2024
|
JCOVDEN
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/20/1525
|
25.7.2024
|
|
24.7.2024
|
Kaletra
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/01/172
|
25.7.2024
|
|
24.7.2024
|
Leflunomide medac
|
|
medac Gesellschaft für klinische Spezialpräparate mbH
|
|
Theaterstraße 6, 22880 Wedel, Deutschland
|
|
EU/1/10/637
|
25.7.2024
|
|
24.7.2024
|
Leflunomide Zentiva
|
|
Zentiva k.s.
|
|
U kabelovny 130, 102 37 Praha 10, Česká republika
|
|
EU/1/09/604
|
29.7.2024
|
|
24.7.2024
|
Mvabea
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/20/1445
|
25.7.2024
|
|
24.7.2024
|
Nexavar
|
|
Bayer AG
|
|
D-51368 Leverkusen, Deutschland
|
|
EU/1/06/342
|
25.7.2024
|
|
24.7.2024
|
Pregabalin Viatris
|
|
Viatris Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/15/997
|
25.7.2024
|
|
24.7.2024
|
Pyzchiva
|
|
Samsung Bioepis NL B.V.
|
|
Olof Palmestraat 10, 2616 LR Delft, Nederland
|
|
EU/1/24/1801
|
30.7.2024
|
|
24.7.2024
|
Skyrizi
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/19/1361
|
25.7.2024
|
|
24.7.2024
|
Suboxone
|
|
Indivior Europe Limited
|
|
27 Windsor Place, Dublin 2, D02 DK44, Ireland
|
|
EU/1/06/359
|
25.7.2024
|
|
24.7.2024
|
TUKYSA
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/20/1526
|
30.7.2024
|
|
26.7.2024
|
Artesunate Amivas
|
|
Amivas Ireland Ltd
|
|
Suite 5, Second Floor, Station House, Railway Square, Waterford, Ireland
|
|
EU/1/21/1582
|
31.7.2024
|
|
26.7.2024
|
AYVAKYT
|
|
Blueprint Medicines (Netherlands) B.V.
|
|
Gustav Mahlerplein 2, 1082 MA Amsterdam, Nederland
|
|
EU/1/20/1473
|
29.7.2024
|
|
26.7.2024
|
Efficib
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/08/457
|
29.7.2024
|
|
26.7.2024
|
Eliquis
|
|
Bristol-Myers Squibb/Pfizer EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
|
|
EU/1/11/691
|
29.7.2024
|
|
26.7.2024
|
Epidyolex
|
|
Jazz Pharmaceuticals Ireland Ltd
|
|
5th Floor, Waterloo Exchange, Waterloo Road, Dublin D04 E5W7, Ireland
|
|
EU/1/19/1389
|
30.7.2024
|
|
26.7.2024
|
Fareston
|
|
Orion Corporation
|
|
Orionintie 1, 02200 Espoo, Suomi
|
|
EU/1/96/004
|
29.7.2024
|
|
26.7.2024
|
Imcivree
|
|
Rhythm Pharmaceuticals Netherlands B.V.
|
|
Radarweg 29, 1043 NX Amsterdam, Nederland
|
|
EU/1/21/1564
|
29.7.2024
|
|
26.7.2024
|
Imfinzi
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/18/1322
|
29.7.2024
|
|
26.7.2024
|
Janumet
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/08/455
|
29.7.2024
|
|
26.7.2024
|
Orladeyo
|
|
Biocryst Ireland Limited
|
|
Block 4, Harcourt Centre, Harcourt Road, Dublin 2, D02 HW77, Ireland
|
|
EU/1/21/1544
|
29.7.2024
|
|
26.7.2024
|
Quinsair
|
|
Chiesi Farmaceutici S.p.A.
|
|
Via Palermo 26/A, 43122 Parma, Italia
|
|
EU/1/14/973
|
31.7.2024
|
|
26.7.2024
|
Teriflunomide Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
|
EU/1/22/1693
|
29.7.2024
|
|
26.7.2024
|
Vabysmo
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/22/1683
|
29.7.2024
|
|
26.7.2024
|
Velmetia
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/08/456
|
29.7.2024
|
|
26.7.2024
|
Vumerity
|
|
Biogen Netherlands B.V.
|
|
Prins Mauritslaan 13, 1171 LP Badhoevedorp, Nederland
|
|
EU/1/21/1585
|
31.7.2024
|
|
26.7.2024
|
Zubsolv
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
|
EU/1/17/1233
|
29.7.2024
|
|
29.7.2024
|
Atazanavir Viatris
|
|
Viatris Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/16/1091
|
30.7.2024
|
|
29.7.2024
|
Jalra
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/08/485
|
1.8.2024
|
|
29.7.2024
|
Lopinavir/Ritonavir Viatris
|
|
Viatris Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/15/1067
|
30.7.2024
|
|
29.7.2024
|
Myalepta
|
|
Chiesi Farmaceutici S.p.A.
|
|
Via Palermo 26/A, 43122 Parma, Italia
|
|
EU/1/18/1276
|
30.7.2024
|
|
29.7.2024
|
Rasagiline Viatris
|
|
Viatris Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/16/1090
|
30.7.2024
|
|
29.7.2024
|
Xiliarx
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/08/486
|
1.8.2024
|
|
