Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan, decision type: PM: decision on the application for ...
P/0012/2023 : EMA decision of 31 January 2023 on the acceptance of a modification of an agreed paediatric investigation plan for macitentan (Opsumit), (EMEA-001032-PIP01-10-M05) First published: 14/02/2024