EMEA-001742-PIP01-14-M01

Key facts

Active substance	Derivative of 4H-pyrazolo[3,4-d]pyrimidin-4-one
Therapeutic area	Psychiatry
Decision number	P/0312/2020
PIP number	EMEA-001742-PIP01-14-M01
Pharmaceutical form(s)	Film-coated tablet
Condition(s) / indication(s)	Treatment of schizophrenia
Route(s) of administration	Oral use
Contact for public enquiries	Boehringer Ingelheim International GmbH Tel. +49 6132 778271 Email: Paediatrics@boehringer-ingelheim.com
Decision type	PM: decision on the application for modification of an agreed PIP

Decision

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P/0312/2020: EMA decision of 14 August 2020 on the refusal of a modification of an agreed paediatric investigation plan for derivative of 4Hpyrazolo[ 3,4-d]pyrimidin-4-one (BI409306) (EMEA-001742-PIP01-14-M01) (PDF/509.97 KB)

Adopted

First published: 30/06/2021
EMA/413702/2020

Related documents

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Derivative of 4Hpyrazolo[3,4-d]pyrimidin-4-one (BI409306) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/80.15 KB) (new)

First published: 22/05/2023
EMEA-001742-PIP01-14

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