Human medicines European public assessment report (EPAR): Miglustat Dipharma, miglustat, Date of authorisation: 18/02/2019, Revision: 9, Status: Authorised

Submitted by Anonymous (not verified) on 4 September 2026 - 14:06

Human medicines European public assessment report (EPAR): Miglustat Dipharma, miglustat, Date of authorisation: 18/02/2019, Revision: 9, Status: Authorised

Opinion/decision on a Paediatric investigation plan (PIP): Skyclarys, omaveloxolone, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Congenital, familial and genetic diso

Submitted by Anonymous (not verified) on 4 September 2026 - 11:23

Opinion/decision on a Paediatric investigation plan (PIP): Skyclarys, omaveloxolone, decision type: P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s), therapeutic area: Congenital, familial and genetic disorders, PIP number: EMA/PE/0000338563

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