Zynquista

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sotagliflozin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Zynquista has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 16/08/2022

Authorisation details

Product details
Name
Zynquista
Agency product number
EMEA/H/C/004889
Active substance
Sotagliflozin
International non-proprietary name (INN) or common name
sotagliflozin
Therapeutic area (MeSH)
Diabetes Mellitus, Type 1
Anatomical therapeutic chemical (ATC) code
A10
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Guidehouse Germany GmbH
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
26/04/2019
Contact address

Geschäftsanschrift
Albrechtstraße 10 c
10117 Berlin
Germany

Product information

22/03/2022 Zynquista - EMEA/H/C/004889 - IAIN/0005

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.

 

Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Zynquista is indicated as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus with a Body Mass Index (BMI) ≥ 27 kg/m2, who have failed to achieve adequate glycaemic control despite optimal insulin therapy.

Assessment history

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