Zynquista

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sotagliflozin

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 16/05/2019

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
sanofi-aventis groupe
Date of issue of marketing authorisation valid throughout the European Union
26/04/2019
Contact address

54 rue La Boetie
75008 Paris
France

Product information

26/04/2019 Zynquista - EMEA/H/C/004889 -

Contents

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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.

Assessment history

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