Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiovascular diseases, PIP number: P/0012/2023

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

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Opinion/decision on a Paediatric investigation plan (PIP): Opsumit, Macitentan, decision type: PM: decision on the application for modification of an agreed PIP, therapeutic area: Cardiovascular diseases, PIP number: P/0012/2023

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