Opinion/decision on a Paediatric investigation plan (PIP): Reagila, Cariprazine (hydrochloride), decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP, therapeutic area: Psychiatry, PIP number: P/0061/2023

P/0061/2023 : EMA decision of 24 February 2023 on the refusal of a modification of an agreed paediatric investigation plan for cariprazine (hydrochloride) (Reagila), (EMEA-001652-PIP01-14-M04)

First published: 28/02/2024Reference Number: EMA/74599/2023

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Opinion/decision on a Paediatric investigation plan (PIP): Reagila, Cariprazine (hydrochloride), decision type: RPM: decision refers to a refusal on the application for modification of an agreed PIP, therapeutic area: Psychiatry, PIP number: P/0061/2023

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