Opening procedures at EMA to non-EU authorities (OPEN) initiative
Opening procedures at EMA to non-EU authorities (OPEN) initiative
Opening procedures at EMA to non-EU authorities (OPEN) initiative
Questions and Answers on the 'OPEN' Framework
Final Minutes – HMA-EMA joint Big Data Steering Group teleconference - 27 May 2024
List of signals discussed at PRAC since September 2012
EMEA-002052-PIP02-23
Opinion/decision on a Paediatric investigation plan (PIP): Cosentyx, Secukinumab, decision type: W: decision granting a waiver in all age groups for all conditions or indications, therapeutic area: Immunology-Rheumatology-Transplantation, PIP number: P/0201/2023
Opinion/decision on a Paediatric investigation plan (PIP): Regkirona, Regdanvimab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Vaccines, PIP number: P/0238/2023
Opinion/decision on a Paediatric investigation plan (PIP): Xevudy, Sotrovimab, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Infectious diseases, PIP number: P/0235/2023
EMEA-002762-PIP02-20-M01
EMEA-002735-PIP03-20-M02