Zynquista
sotagliflozin
Table of contents
Overview
The marketing authorisation for Zynquista has been withdrawn at the request of the marketing-authorisation holder.
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Zynquista : EPAR - Medicine overview (PDF/665.64 KB)
First published: 16/05/2019
Last updated: 16/08/2022 -
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Zynquista : EPAR - Risk-management-plan summary (PDF/720.08 KB)
First published: 16/05/2019
Last updated: 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 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 |
Product information
22/03/2022 Zynquista - EMEA/H/C/004889 - IAIN/0005
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:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.