EMEA-001865-PIP02-16

Key facts

Active substance	Omega-3-carboxylic acids
Therapeutic area	Cardiovascular diseases
Decision number	P/0377/2017
PIP number	EMEA-001865-PIP02-16
Pharmaceutical form(s)	Capsule, soft Age-appropriate dosage form, other
Condition(s) / indication(s)	Treatment of dyslipidaemia
Route(s) of administration	Oral use
Contact for public enquiries	AstraZeneca AB Tel. +46 8553 27591 E-mail: paediatrics@astrazeneca.com
Decision type	PM: decision on the application for modification of an agreed PIP

Decision

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P/0377/2017: EMA decision of 1 December 2017 on the agreement of a paediatric investigation plan and on the granting of a deferral and on the granting of a waiver for omega-3-carboxylic acids (EMEA-001865-PIP02-16) (PDF/96.89 KB)

Adopted

First published: 05/03/2018
Last updated: 05/03/2018
EMA/704196/2017

Related documents

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Omega-3-carboxylic acids - Notification of discontinuation of a paediatric development which is covered by an agreed PIP Decision (PDF/60.5 KB)

First published: 06/02/2023

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