Human medicines European public assessment report (EPAR): Veanibek (previously Miglustat Gen.Orph), miglustat, Date of authorisation: 09/11/2017, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Veanibek (previously Miglustat Gen.Orph), miglustat, Date of authorisation: 09/11/2017, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Vlustozik (previously Ibuprofen Gen.Orph), ibuprofen, Date of authorisation: 16/02/2024, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Vlustozik (previously Ibuprofen Gen.Orph), ibuprofen, Date of authorisation: 16/02/2024, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Bildyos, denosumab, Date of authorisation: 17/09/2025, Revision: 5, Status: Authorised

Human medicines European public assessment report (EPAR): Sycrest, asenapine, Date of authorisation: 01/09/2010, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR): Rozlytrek, entrectinib, Date of authorisation: 31/07/2020, Revision: 11, Status: Authorised

Human medicines European public assessment report (EPAR): Otulfi, ustekinumab, Date of authorisation: 25/09/2024, Revision: 8, Status: Authorised

Withdrawn application: Truqap, 16/09/2026

Human medicines European public assessment report (EPAR): Zokinvy, lonafarnib, Date of authorisation: 18/07/2022, Revision: 6, Status: Authorised