EMEA-000694-PIP02-14-M03

Table of contents

Key facts
Decision

Key facts

Invented name	Forxiga
Active substance	dapagliflozin
Therapeutic area	Endocrinology-Gynaecology-Fertility-Metabolism
Decision number	P/0161/2022
PIP number	EMEA-000694-PIP02-14-M03
Pharmaceutical form(s)	Film-coated tablet Age-appropriate oral dosage form
Condition(s) / indication(s)	Treatment of type I diabetes mellitus
Route(s) of administration	Oral use
Contact for public enquiries	AstraZeneca AB E-mail: paediatrics@astrazeneca.com Tel. +46(8)55324400
Decision type	PM: decision on the application for modification of an agreed PIP

Decision

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P/0161/2022 : EMA decision of 13 May 2022 on the acceptance of a modification of an agreed paediatric investigation plan for dapagliflozin (Forxiga), (EMEA-000694-PIP02-14-M03) (PDF/233.42 KB) (new)

Adopted

First published: 12/05/2023
EMA/169194/2022

Related content

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Public summary of the evaluation of a proposed paediatric investigation plan: Dapagliflozin (Forxiga) for the treatment of type-1 diabetes mellitus (PDF/94.66 KB)

First published: 11/07/2016
Last updated: 11/07/2016
EMA/255315/2016

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