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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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4.8.2025
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Beyfortus
|
|
Sanofi Winthrop Industrie
|
|
82 avenue Raspail, 94250 Gentilly, France
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|
EU/1/22/1689
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9.8.2025.
|
|
4.8.2025
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Bortezomib Hospira
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/16/1114
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5.8.2025.
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|
4.8.2025
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Clopidogrel Zentiva
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Zentiva, k.s.
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U Kabelovny 130, 102 37 Praha 10, Česká republika
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|
EU/1/08/465
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5.8.2025.
|
|
4.8.2025
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IMJUDO
|
|
AstraZeneca AB
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|
151 85 Södertälje, Sverige
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EU/1/22/1713
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5.8.2025.
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4.8.2025
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INCRELEX
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Esteve Pharmaceuticals S.A.
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|
Passeig de La Zona Franca 109 Planta 4, 08038 Barcelona, España
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|
EU/1/07/402
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5.8.2025.
|
|
4.8.2025
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Nplate
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Amgen Europe B.V.
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|
Minervum 7061, 4817 ZK Breda, Nederland
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EU/1/08/497
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5.8.2025.
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4.8.2025
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Nyvepria
|
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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/1/20/1486
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5.8.2025.
|
|
4.8.2025
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Oxlumo
|
|
Alnylam Netherlands B.V.
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|
Antonio Vivaldistraat 150, 1083 HP Amsterdam, Nederland
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|
EU/1/20/1496
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5.8.2025.
|
|
4.8.2025
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Sitagliptin/Metformin hydrochloride 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/1/22/1661
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5.8.2025.
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|
4.8.2025
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Skilarence
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|
Almirall, S.A.
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|
Ronda General Mitre, 151, 08022 Barcelona, España
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|
EU/1/17/1201
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19.8.2025.
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|
4.8.2025
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Symkevi
|
|
Vertex Pharmaceuticals (Ireland) Limited
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|
Unit 49, Block F2, Northwood Court, Santry, Dublin 9, D09 T665, Ireland
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|
EU/1/18/1306
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13.8.2025.
|
|
4.8.2025
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Tenkasi
|
|
Menarini International Operations Luxembourg S.A.
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|
1 avenue de la Gare, 1611 Luxembourg, Luxembourg
|
|
EU/1/15/989
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5.8.2025.
|
|
4.8.2025
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Yorvipath
|
|
Ascendis Pharma Bone Diseases A/S
|
|
Tuborg Boulevard 12, DK-2900 Hellerup, Danmark
|
|
EU/1/23/1766
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6.8.2025.
|
|
6.8.2025
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Fampyra
|
|
Merz Therapeutics GmbH
|
|
Eckenheimer Landstraße 100, 60318 Frankfurt Am Main, Deutschland
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EU/1/11/699
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8.8.2025.
|
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6.8.2025
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Lemtrada
|
|
Sanofi Belgium
|
|
Leonardo Da Vincilaan 19, B-1831 Diegem, België
|
|
EU/1/13/869
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11.8.2025.
|
|
6.8.2025
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Lemtrada
|
|
Sanofi Belgium
|
|
Leonardo Da Vincilaan 19, B-1831 Diegem, België
|
|
EU/1/13/869
|
11.8.2025.
|
|
6.8.2025
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Luveris
|
|
Merck Europe B.V.
|
|
Gustav Mahlerplein 102, 1082 MA Amsterdam, Nederland
|
|
EU/1/00/155
|
7.8.2025.
|
|
6.8.2025
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Rivaroxaban Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
|
EU/1/20/1488
|
7.8.2025.
|
|
6.8.2025
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Ruconest
|
|
Pharming Group N.V.
|
|
Darwinweg 24, 2333 CR Leiden, Nederland
|
|
EU/1/10/641
|
7.8.2025.
|
|
6.8.2025
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Wezenla
|
|
Amgen Technology (Ireland) UC
|
|
Pottery Road, Dun Laoghaire, Co. Dublin, Ireland
|
|
EU/1/24/1823
|
7.8.2025.
|
|
11.8.2025
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Arava
|
|
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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22.8.2025.
|
|
11.8.2025
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Eksunbi
|
|
Samsung Bioepis NL B.V.
|
|
Olof Palmestraat 10, 2616 LR Delft, Nederland
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|
EU/1/24/1858
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12.8.2025.
|
|
11.8.2025
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TALVEY
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Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
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|
EU/1/23/1748
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12.8.2025.
|
|
11.8.2025
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TECVAYLI
|
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Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
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|
EU/1/22/1675
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12.8.2025.
|
|
11.8.2025
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Xaluprine
|
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Lipomed GmbH
|
|
Hegenheimer Straße 2, 79576 Weil/Rhein, Deutschland
|
|
EU/1/11/727
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12.8.2025.
|
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14.8.2025
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Brukinsa
|
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BeOne Medicines Ireland Limited
|
|
10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
|
|
EU/1/21/1576
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20.8.2025.
|
|
14.8.2025
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Emselex
|
|
pharmaand GmbH
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|
Taborstrasse 1, 1020 Wien, Österreich
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|
EU/1/04/294
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19.8.2025.
|
|
14.8.2025
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Invega
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
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|
EU/1/07/395
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19.8.2025.
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|
14.8.2025
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Leflunomide medac
|
|
medac Gesellschaft für klinische Spezialpräparate mbH
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Theaterstraße 6, 22880 Wedel, Deutschland
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EU/1/10/637
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20.8.2025.
|
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14.8.2025
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OBIZUR
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Baxalta Innovations GmbH
|
|
Industriestraße 67, 1221 Wien, Österreich
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|
EU/1/15/1035
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18.8.2025.
|
|
14.8.2025
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Pyzchiva
|
|
Samsung Bioepis NL B.V.
|
|
Olof Palmestraat 10, 2616 LR Delft, Nederland
|
|
EU/1/24/1801
|
19.8.2025.
|
|
14.8.2025
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REKAMBYS
|
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Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/20/1482
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19.8.2025.
|
|
14.8.2025
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Roclanda
|
|
Santen Oy
|
|
Niittyhaankatu 20, 33720 Tampere, Suomi
|
|
EU/1/20/1502
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26.8.2025.
|
|
14.8.2025
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Spevigo
|
|
Boehringer Ingelheim International GmbH
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|
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland
|
|
EU/1/22/1688
|
18.8.2025.
|
|
14.8.2025
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TRIXEO AEROSPHERE
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/20/1498
|
18.8.2025.
|
|
14.8.2025
|
Vocabria
|
|
ViiV Healthcare BV
|
|
Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland
|
|
EU/1/20/1481
|
19.8.2025.
|
|
14.8.2025
|
Zinforo
|
|
Pfizer Ireland Pharmaceuticals Unlimited Company
|
|
Operations Support Group, Ringaskiddy, County Cork, Ireland
|
|
EU/1/12/785
|
18.8.2025.
|
|
18.8.2025
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Arexvy
|
|
GlaxoSmithKline Biologicals S.A.
|
|
rue de l'Institut 89, 1330 Rixensart, Belgique
|
|
EU/1/23/1740
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19.8.2025.
|
|
18.8.2025
|
Herceptin
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/00/145
|
19.8.2025.
|
|
18.8.2025
|
Neupro
|
|
UCB Pharma S.A.
|
|
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België
|
|
EU/1/05/331
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19.8.2025.
|
|
21.8.2025
|
Diacomit
|
|
Biocodex
|
|
22 rue des Aqueducs, 94250 Gentilly, France
|
|
EU/1/06/367
|
22.8.2025.
|
|
21.8.2025
|
Imnovid
|
|
Bristol Myers Squibb Pharma EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, Dublin 15, D15 T867, Ireland
|
|
EU/1/13/850
|
25.8.2025.
|
|
21.8.2025
|
Lenalidomide Mylan
|
|
Mylan Pharmaceuticals Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/20/1490
|
22.8.2025.
|
|
21.8.2025
|
Ondexxya
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/18/1345
|
22.8.2025.
|
|
21.8.2025
|
Rybrevant
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/21/1594
|
22.8.2025.
|
|
21.8.2025
|
Tevimbra
|
|
BeOne Medicines Ireland Limited
|
|
10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
|
|
EU/1/23/1758
|
25.8.2025.
|
|
22.8.2025
|
Abecma
|
|
Bristol-Myers Squibb Pharma EEIG
|
|
Plaza 254, Blanchardstown Corporate Park 2, D15 T867, Dublin 15, Ireland
|
|
EU/1/21/1539
|
26.8.2025.
|
|
22.8.2025
|
Alhemo
|
|
Novo Nordisk A/S
|
|
Novo Alle 1, 2880 Bagsvaerd, Danmark
|
|
EU/1/24/1881
|
25.8.2025.
|
|
22.8.2025
|
Baqsimi
|
|
Amphastar France Pharmaceuticals
|
|
Usine Saint Charles, Eragny Sur Epte, 60590 France
|
|
EU/1/19/1406
|
25.8.2025.
|
|
22.8.2025
|
Clopidogrel Zentiva
|
|
Zentiva, k.s.
|
|
U Kabelovny 130, 102 37 Praha 10, Česká republika
|
|
EU/1/08/465
|
26.8.2025.
|
|
22.8.2025
|
Invokana
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/13/884
|
25.8.2025.
|
|
22.8.2025
|
Omvoh
|
|
Eli Lilly Nederland B.V.
|
|
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
|
EU/1/23/1736
|
26.8.2025.
|
|
22.8.2025
|
Roctavian
|
|
BioMarin International Limited
|
|
Shanbally, Ringaskiddy, County Cork, P43 R298, Ireland
|
|
EU/1/22/1668
|
25.8.2025.
|
|
22.8.2025
|
Sirturo
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/13/901
|
25.8.2025.
|
|
22.8.2025
|
Sugamadeks Adroiq
|
|
Extrovis EU Ltd.
|
|
Pátriárka utca 14., 2000, Szentendre, Magyarország
|
|
EU/1/23/1733
|
25.8.2025.
|
|
22.8.2025
|
Taltz
|
|
Eli Lilly and Company (Ireland) Limited
|
|
Dunderrow, Kinsale, Co. Cork, Ireland
|
|
EU/1/15/1085
|
25.8.2025.
|
|
28.8.2025
|
Accofil
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/14/946
|
29.8.2025.
|
|
28.8.2025
|
Enspryng
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/21/1559
|
29.8.2025.
|
|
28.8.2025
|
Livmarli
|
|
Mirum Pharmaceuticals International B.V.
|
|
Kingsfordweg 151, 1043 GR Amsterdam, Noord-Holland, Nederland
|
|
EU/1/22/1704
|
2.9.2025.
|
|
28.8.2025
|
Moventig
|
|
Grünenthal GmbH
|
|
Zieglerstraße 6, 52078, Aachen, Deutschland
|
|
EU/1/14/962
|
29.8.2025.
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