Orphan designation: 3-chloro-4-fluorophenyl-(4-fluoro-4-(((5-methylpyrimidin-2-ylmethyl)amino)methyl)piperidin-1yl)methanone Treatment of fragile X syndrome, 11/11/2024 Positive

Human medicines European public assessment report (EPAR): Bydureon, exenatide, Date of authorisation: 17/06/2011, Revision: 27, Status: Authorised

List of industry subject matter experts and list of planned calls for industry subject matter experts

Veterinary Scientific Advice procedure - submission deadlines 2025

EMEA-001855-PIP01-15-M05

Opinion/decision on a Paediatric investigation plan (PIP): Kyprolis, carfilzomib, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology;Oncology, PIP number: P/0408/2023

EMEA-002243-PIP01-17-M04

EMEA-002519-PIP03-21-M01

Opinion/decision on a Paediatric investigation plan (PIP): Briviact (in Italy: Nubriveo), Brivaracetam, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: P/0398/2023

Opinion/decision on a Paediatric investigation plan (PIP): Xerava, eravacycline, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0397/2023