Qtrilmet
Withdrawn
This medicine's authorisation has been withdrawn
metformin hydrochloride / saxagliptin / dapagliflozin
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 14 August 2020, the European Commission withdrew the marketing authorisation for Qtrilmet (metformin hydrochloride / saxagliptin / dapagliflozin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, AstraZeneca AB, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.
Qtrilmet was granted marketing authorisation in the EU on 11 November 2019 for the following indications in adults aged 18 years and older with type 2 diabetes mellitus:
- to improve glycaemic control when metformin, with or without sulphonylurea (SU), and either saxagliptin or dapagliflozin does not provide adequate glycaemic control
- when already being treated with metformin and saxagliptin and dapagliflozin.
The marketing authorisation was initially valid for a 5-year period. The product had not yet been marketed in the EU.
The European Public Assessment Report (EPAR) for Qtrilmet is updated to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IB/0003
14/08/2020
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).
Product details
- Name of medicine
- Qtrilmet
- Active substance
- metformin hydrochloride
- saxagliptin
- dapagliflozin
- International non-proprietary name (INN) or common name
- metformin hydrochloride
- saxagliptin
- dapagliflozin
- Therapeutic area (MeSH)
- Diabetes Mellitus, Type 2
- Anatomical therapeutic chemical (ATC) code
- A10BD
Pharmacotherapeutic group
Drugs used in diabetesTherapeutic indication
Qtrilmet is indicated in adults aged 18 years and older with type 2 diabetes mellitus:
- to improve glycaemic control when metformin with or without sulphonylurea (SU) and either saxagliptin or dapagliflozin does not provide adequate glycaemic control.
- when already being treated with metformin and saxagliptin and dapagliflozin.
News on Qtrilmet
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