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Opinion/decision on a Paediatric investigation plan (PIP): 4-[3-(Methylsulfonyl)phenyl]-1-propylpiperidine x HC1 (pridopidine hydrochloride), decision type: , therapeutic area: , PIP number: P/0546/2022

Reflection paper on ethical and good-clinical-practice aspects of clinical trials of medicinal products for human use conducted outside of the European Union (EU) / European Economic Area and submitted in marketing-autho...

Opinion/decision on a Paediatric investigation plan (PIP): exanatide, decision type: , therapeutic area: , PIP number: P/0475/2022

European experts

Opinion/decision on a Paediatric investigation plan (PIP): cobolimab, decision type: , therapeutic area: , PIP number: P/0512/2022

Human medicines European public assessment report (EPAR): Xadago, safinamide, Parkinson Disease, Date of authorisation: 23/02/2015, Revision: 13, Status: Authorised

Human medicines European public assessment report (EPAR): Mounjaro, tirzepatide, Diabetes Mellitus, Type 2, Date of authorisation: 15/09/2022, Revision: 3, Status: Authorised

Appendix, on disclosure rules, to the functional specifications for the EU portal and EU database to be audited