EMEA-002974-PIP01-21

Key facts

Active substance	Benzylamine derivative of benzofuran (BCX9930)
Therapeutic area	Haematology-Hemostaseology
Decision number	P/0125/2022
PIP number	EMEA-002974-PIP01-21
Pharmaceutical form(s)	Age-appropriate oral solid dosage form Tablet
Condition(s) / indication(s)	Treatment of paroxysmal nocturnal haemoglobinuria
Route(s) of administration	Oral use
Contact for public enquiries	BioCryst Ireland Limited +1 9842450602 pip.enquiries@biocryst.com
Decision type	P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)

Decision

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P/0125/2022 : EMA decision of 15 April 2022 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for benzylamine derivative of benzofuran (BCX9930) (EMEA-002974-PIP01-21) (PDF/299.5 KB)

Adopted

First published: 17/04/2023
EMA/149065/2022

Related documents

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Benzylamine derivative of benzofuran (BCX9930) : Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/111.17 KB)

First published: 06/07/2023
EMEA-002974-PIP01-21

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