Human medicines European public assessment report (EPAR): Semglee, insulin glargine, Date of authorisation: 23/03/2018, Revision: 12, Status: Authorised

Orphan designation: 1-Deoxygalactonojirimycin hydrochloride Treatment of Fabry disease, 22/05/2006 Expired

EMA/PE/0000232890

How to recognise scams and phishing using EMA credentials

Opinion/decision on a Paediatric investigation plan (PIP): Sotyktu, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Skin and subcutaneous tissue disorders, PIP number: P/0008/2024

Opinion/decision on a Paediatric investigation plan (PIP): Stelara, ustekinumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Gastrointestinal disorders, PIP number: P/0084/2021

EMA/PE/0000227963

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EU Implementation Guide (IG) on veterinary medicines product data in the Union Product Database - Chapter 7: Submission of other post-authorisation data

Timetable: Type II variation and worksharing application assessment - ATMP