Zynquista
Withdrawn
This medicine's authorisation has been withdrawn
sotagliflozin
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 22 March 2022, the European Commission withdrew the marketing authorisation for Zynquista (sotagliflozin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Guidehouse Germany GmbH, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Zynquista was granted marketing authorisation in the EU on 26 April 2019 for use as an adjunct to insulin therapy to improve glycaemic control in adults with type 1 diabetes mellitus. The marketing authorisation was initially valid for a 5-year period.
The European Public Assessment Report (EPAR) for Zynquista is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IAIN/0005
22/03/2022
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).
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.
News on Zynquista
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