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

EMEA-002735-PIP01-19-M01

Opinion/decision on a Paediatric investigation plan (PIP): Ontozry, cenobamate, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Neurology, PIP number: P/0214/2023

EMEA-002229-PIP02-21-M01