EMEA-001517-PIP02-14-M03

Table of contents

Key facts
Decision
Related information

Key facts

Invented name	Zynquista
Active substance	Sotagliflozin
Therapeutic area	Endocrinology-Gynaecology-Fertility-Metabolism
Decision number	P/0226/2021
PIP number	EMEA-001517-PIP02-14-M03
Pharmaceutical form(s)	Granules Film-coated tablet
Condition(s) / indication(s)	Treatment of type I diabetes mellitus
Route(s) of administration	Oral use
Contact for public enquiries	Guidehouse Germany GmbH E-mail: KKasslerTaub@lexpharma.com Tel: +1 9089638536
Decision type	PM: decision on the application for modification of an agreed PIP

Decision

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P/0226/2021 : EMA decision of 8 June 2021 on the acceptance of a modification of an agreed paediatric investigation plan for sotagliflozin (Zynquista) (EMEA-001517-PIP02-14-M03) (PDF/282.18 KB)

Adopted

First published: 28/04/2022
EMA/235313/2021 corr

Related content

Zynquista: EPAR

Related information

List item

Summary of the evaluation of the proposed paediatric investigation plan: Sotagliflozin for treatment of type 1 diabetes mellitus (PDF/90.71 KB)

First published: 19/10/2015
Last updated: 19/10/2015
EMA/628992/2015

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