Osservatorio Regolatorio Pharma – 2026-08-05

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Pubblicazioni dal 04/08/2026 15:40 a ora — 9 news

EMA – What's new (8)

Human medicines European public assessment report (EPAR): Kisqali, ribociclib, Date of authorisation: 22/08/2017, Revision: 27, Status: Authorised

Human medicines European public assessment report (EPAR): Caprelsa, vandetanib, Date of authorisation: 16/02/2012, Revision: 32, Status: Authorised

Human medicines European public assessment report (EPAR): Vantobra (previously Tobramycin PARI), tobramycin, Date of authorisation: 18/02/2019, Revision: 7, Status: Authorised

Human medicines European public assessment report (EPAR): Iqirvo, elafibranor, Date of authorisation: 19/09/2024, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Humira, adalimumab, Date of authorisation: 08/09/2003, Revision: 98, Status: Authorised

Human medicines European public assessment report (EPAR): Leqembi, lecanemab, Date of authorisation: 15/04/2025, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Arikayce liposomal, amikacin, Date of authorisation: 27/10/2020, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Signifor, pasireotide, Date of authorisation: 24/04/2012, Revision: 16, Status: Authorised

EU Union Register of Medicinal Products (1)

Tavneos (Vifor Fresenius Medical Care Renal Pharma France)

Tavneos (Active substance: avacopan) - Referral - Commission Decision (2026) 5725 of Tue, 04 Aug 2026 - European Medicines Agency (EMA) procedure number: EMA/REF/0000325221

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