Qtrilmet
metformin hydrochloride / saxagliptin / dapagliflozin
Table of contents
Overview
The marketing authorisation for Qtrilmet has been withdrawn at the request of the marketing-authorisation holder.
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List item
Qtrilmet : EPAR - Medicine overview (PDF/579.13 KB)
First published: 10/12/2019
Last updated: 09/10/2020
EMA/521799/2019 -
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List item
Qtrilmet : EPAR - Risk-management-plan summary (PDF/610.53 KB)
First published: 10/12/2019
Last updated: 09/10/2020
Authorisation details
| Product details | |
|---|---|
| Name |
Qtrilmet
|
| Agency product number |
EMEA/H/C/004910
|
| Active substance |
|
| International non-proprietary name (INN) or common name |
|
| Therapeutic area (MeSH) |
Diabetes Mellitus, Type 2
|
| Anatomical therapeutic chemical (ATC) code |
A10BD
|
| Publication details | |
|---|---|
| Marketing-authorisation holder |
AstraZeneca AB
|
| Revision |
2
|
| Date of issue of marketing authorisation valid throughout the European Union |
11/11/2019
|
| Contact address |
AstraZeneca AB |
Product information
14/08/2020 Qtrilmet - EMEA/H/C/004910 - IB/0003
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Drugs used in diabetes
Therapeutic 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.