Zynquista
sotagliflozin
Table of contents
Overview
Zynquista is a diabetes medicine used with insulin to treat adults with type 1 diabetes. It is used in overweight patients (body mass index of at least 27 kg/m2) when insulin on its own does not control blood sugar well enough.
Zynquista contains the active substance sotagliflozin.
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Zynquista : EPAR - Medicine overview (PDF/77.83 KB)
First published: 16/05/2019 -
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Zynquista : EPAR - Risk-management-plan summary (PDF/92.54 KB)
First published: 16/05/2019
Authorisation details
Product details | |
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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 | |
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Marketing-authorisation holder |
Guidehouse Germany GmbH
|
Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
26/04/2019
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Contact address |
Product information
24/09/2020 Zynquista - EMEA/H/C/004889 - IAIN/0005
Contents
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
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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.