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Datum van het besluit
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Naam van het geneesmiddel
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Houder van de vergunning voor het in de handel brengen
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Nr. in het communautair geneesmiddelenregister
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Datum van kennisgeving
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|
1.10.2025
|
Adasuve
|
|
Ferrer Internacional S.A.
|
|
Gran Via Carlos III 94, 08028 Barcelona, España
|
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EU/1/13/823
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9.10.2025
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|
1.10.2025
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Celsentri
|
|
ViiV Healthcare BV
|
|
Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland
|
|
EU/1/07/418
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2.10.2025
|
|
1.10.2025
|
Nuvaxovid
|
|
Sanofi Winthrop Industrie
|
|
82 avenue Raspail, 94250 Gentilly, France
|
|
EU/1/21/1618
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2.10.2025
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|
1.10.2025
|
Prevenar 20
|
|
Pfizer Europe MA EEIG
|
|
Boulevard de la Plaine 17, 1050 Bruxelles, Belgique/ Pleinlaan 17, 1050 Brussel, België
|
|
EU/1/21/1612
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2.10.2025
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|
1.10.2025
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Tivicay
|
|
ViiV Healthcare BV
|
|
Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Nederland
|
|
EU/1/13/892
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2.10.2025
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|
1.10.2025
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Viramune
|
|
Boehringer Ingelheim International GmbH
|
|
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland
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|
EU/1/97/055
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2.10.2025
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|
2.10.2025
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BIMERVAX
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|
Hipra Human Health, S.L.U.
|
|
Avda. la Selva, 135, 17170 Amer (Girona), España
|
|
EU/1/22/1709
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6.10.2025
|
|
9.10.2025
|
Simponi
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/09/546
|
10.10.2025
|
|
9.10.2025
|
Tofidence
|
|
STADA Arzneimittel AG
|
|
Stadastraße 2-18, 61118 Bad Vilbel, Deutschland
|
|
EU/1/24/1825
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13.10.2025
|
|
13.10.2025
|
Amyvid
|
|
Eli Lilly Nederland B.V.
|
|
Papendorpseweg 83, 3528 BJ Utrecht, Nederland
|
|
EU/1/12/805
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14.10.2025
|
|
13.10.2025
|
Ibandroninezuur Teva
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/10/642
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14.10.2025
|
|
13.10.2025
|
Juluca
|
|
ViiV Healthcare B.V.
|
|
Van Asch van Wijckstraat 55H, 3811 LP Amersfoort, Netherlands
|
|
EU/1/18/1282
|
14.10.2025
|
|
13.10.2025
|
Keppra
|
|
UCB Pharma S.A.
|
|
Allée de la Recherche 60, 1070 Bruxelles, Belgique/Researchdreef 60, 1070 Brussel, België
|
|
EU/1/00/146
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14.10.2025
|
|
13.10.2025
|
Lacosamide Adroiq
|
|
Extrovis EU Kft.
|
|
Raktarvarosi Ut 9, Torokbalint, 2045, Magyarország
|
|
EU/1/23/1732
|
21.10.2025
|
|
17.10.2025
|
Enzalutamide Viatris
|
|
Viatris Limited
|
|
Damastown Industrial Park, Mulhuddart, Dublin 15, DUBLIN, Ireland
|
|
EU/1/24/1842
|
22.10.2025
|
|
17.10.2025
|
Voriconazol Accord
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona s/n, Edifici Est, 6a planta, 08039 Barcelona, España
|
|
EU/1/13/835
|
20.10.2025
|
|
20.10.2025
|
Effentora
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/08/441
|
23.10.2025
|
|
20.10.2025
|
Mycophenolate mofetil Teva
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/07/439
|
27.10.2025
|
|
20.10.2025
|
Myfenax
|
|
Teva B.V.
|
|
Swensweg 5, 2031 GA Haarlem, Nederland
|
|
EU/1/07/438
|
27.10.2025
|
|
20.10.2025
|
Quofenix
|
|
A. Menarini - Industrie Farmaceutiche Riunite - s.r.l.
|
|
Via Sette Santi 3, 50131 Florence, Italia
|
|
EU/1/19/1393
|
23.10.2025
|
|
20.10.2025
|
Tezspire
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/22/1677
|
21.10.2025
|
|
20.10.2025
|
Tremfya
|
|
Janssen-Cilag International NV
|
|
Turnhoutseweg 30, 2340 Beerse, België
|
|
EU/1/17/1234
|
21.10.2025
|
|
20.10.2025
|
Tyverb
|
|
Novartis Europharm Limited
|
|
Vista Building, Elm Park, Merrion Road, Dublin 4, Ireland
|
|
EU/1/07/440
|
21.10.2025
|
|
20.10.2025
|
Zyprexa Velotab
|
|
CHEPLAPHARM Registration GmbH
|
|
Weiler Straße 5e, 79540 Lörrach, Deutschland
|
|
EU/1/99/125
|
24.10.2025
|
|
21.10.2025
|
Ganfort
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/06/340
|
21.10.2025
|
|
24.10.2025
|
Alecensa
|
|
Roche Registration GmbH
|
|
Emil-Barell-Strasse 1, 79639 Grenzach-Wyhlen, Deutschland
|
|
EU/1/16/1169
|
27.10.2025
|
|
24.10.2025
|
Brukinsa
|
|
BeOne Medicines Ireland Limited
|
|
10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
|
|
EU/1/21/1576
|
27.10.2025
|
|
24.10.2025
|
Dovprela
|
|
Mylan IRE Healthcare Limited
|
|
Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
|
|
EU/1/20/1437
|
28.10.2025
|
|
24.10.2025
|
KEYTRUDA
|
|
Merck Sharp & Dohme B.V.
|
|
Waarderweg 39, 2031 BN Haarlem, Nederland
|
|
EU/1/15/1024
|
27.10.2025
|
|
24.10.2025
|
Koselugo
|
|
AstraZeneca AB
|
|
151 85 Södertälje, Sverige
|
|
EU/1/21/1552
|
27.10.2025
|
|
24.10.2025
|
Pyzchiva
|
|
Samsung Bioepis NL B.V.
|
|
Olof Palmestraat 10, 2616 LR Delft, Nederland
|
|
EU/1/24/1801
|
27.10.2025
|
|
24.10.2025
|
Spevigo
|
|
Boehringer Ingelheim International GmbH
|
|
Binger Straße 173, 55216 Ingelheim am Rhein, Deutschland
|
|
EU/1/22/1688
|
28.10.2025
|
|
24.10.2025
|
Tevimbra
|
|
BeOne Medicines Ireland Limited
|
|
10 Earlsfort Terrace, Dublin 2, D02 T380, Ireland
|
|
EU/1/23/1758
|
27.10.2025
|
|
24.10.2025
|
Usymro
|
|
Gedeon Richter Plc.
|
|
Gyömrői út 19-21, 1103 Budapest, Magyarország
|
|
EU/1/25/1957
|
30.10.2025
|
|
24.10.2025
|
Verquvo
|
|
Bayer AG
|
|
D-51368 Leverkusen, Deutschland
|
|
EU/1/21/1561
|
27.10.2025
|
|
24.10.2025
|
Zynlonta
|
|
Swedish Orphan Biovitrum AB (publ)
|
|
112 76 Stockholm, Sverige
|
|
EU/1/22/1695
|
27.10.2025
|
|
24.10.2025
|
Zypadhera
|
|
CHEPLAPHARM Registration GmbH
|
|
Weiler Straße 5e, 79540 Lörrach, Deutschland
|
|
EU/1/08/479
|
28.10.2025
|
|
30.10.2025
|
Kaletra
|
|
AbbVie Deutschland GmbH & Co. KG
|
|
Knollstrasse, 67061 Ludwigshafen, Deutschland
|
|
EU/1/01/172
|
3.11.2025
|
|
30.10.2025
|
Kirsty
|
|
Biosimilar Collaborations Ireland Limited
|
|
Unit 35/36 Grange Parade, Baldoyle Industrial Estate, Dublin 13, D13 R20R, DUBLIN, Ireland
|
|
EU/1/20/1506
|
10.11.2025
|
|
30.10.2025
|
Posaconazole AHCL
|
|
Accord Healthcare S.L.U.
|
|
World Trade Center, Moll de Barcelona, s/n, Edifici Est 6a planta, 08039 Barcelona, España
|
|
EU/1/19/1380
|
3.11.2025
|
