Opinion/decision on a Paediatric investigation plan (PIP): Kalydeco, ivacaftor, decision type: PM: decision on the application for ...
P/0002/2023 : EMA decision of 6 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for ivacaftor (Kalydeco), (EMEA-000335-PIP01-08-M15) First published: 14/02/2024Reference Number: EMA/1721/2023