Overview
The marketing authorisation for Zynquista has been withdrawn at the request of the marketing-authorisation holder.
Zynquista : EPAR - Medicine overview
Zynquista : EPAR - Risk-management-plan summary
Product information
Zynquista : EPAR - Product information
Latest procedure affecting product information: IAIN/0005
22/03/2022
This medicine’s product information is available in all official EU languages.
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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).
Zynquista : EPAR - All Authorised presentations
Product details
- Name of medicine
- Zynquista
- 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
Pharmacotherapeutic group
Drugs used in diabetesTherapeutic 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
Zynquista : EPAR - Procedural steps taken and scientific information after authorisation