Senvelgo

Training session for patients, consumers and healthcare professionals involved in medicine regulatory activities, Online, European Medicines Agency, Amsterdam, the Netherlands, from 5 December 2024, 14:00 (CET) to 13 December 2024, 12:00 (CET)

EMEA-001949-PIP01-16-M05

Opinion/decision on a Paediatric investigation plan (PIP): Ultomiris, ravulizumab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Haematology-Hemostaseology;Uro-nephrology, PIP number: P/0128/2023

Opinion/decision on a Paediatric investigation plan (PIP): Dovato, lamivudine,dolutegravir, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0121/2023

EMEA-001855-PIP01-15-M04

Opinion/decision on a Paediatric investigation plan (PIP): Byfavo, remimazolam besilate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Anaesthesiology, PIP number: P/0110/2023

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/0107/2023

European Union example instances - E2B(R3) testing files

Test cases (1a-10) RTFs