Qtrilmet

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Withdrawn

This medicine's authorisation has been withdrawn

metformin hydrochloride / saxagliptin / dapagliflozin
MedicineHumanWithdrawn
  • 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The European Public Assessment Report (EPAR) for Qtrilmet is updated to indicate that the marketing authorisation is no longer valid.

Qtrilmet : EPAR - Medicine overview

Reference Number: EMA/521799/2019

English (EN) (579.13 KB - PDF)

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български (BG) (626.71 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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español (ES) (579.79 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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čeština (CS) (618.79 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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dansk (DA) (578.96 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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Deutsch (DE) (582.95 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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eesti keel (ET) (567.57 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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ελληνικά (EL) (625.56 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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français (FR) (580.79 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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hrvatski (HR) (602.92 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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italiano (IT) (578.63 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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latviešu valoda (LV) (636.06 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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lietuvių kalba (LT) (602.67 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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magyar (HU) (615.63 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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Malti (MT) (618.89 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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Nederlands (NL) (578.78 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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polski (PL) (620.12 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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português (PT) (580.04 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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română (RO) (601.67 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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slovenčina (SK) (618.69 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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slovenščina (SL) (615.88 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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Suomi (FI) (578.75 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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svenska (SV) (578.25 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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Qtrilmet : EPAR - Risk-management-plan summary

English (EN) (610.53 KB - PDF)

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Product information

Qtrilmet : EPAR - Product information

English (EN) (782.76 KB - PDF)

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български (BG) (971.14 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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español (ES) (784.26 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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čeština (CS) (872.45 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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dansk (DA) (775.74 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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Deutsch (DE) (809.2 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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eesti keel (ET) (753.19 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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ελληνικά (EL) (929.34 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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français (FR) (808.14 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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hrvatski (HR) (761.11 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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íslenska (IS) (769.8 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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italiano (IT) (851.09 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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latviešu valoda (LV) (857.92 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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lietuvių kalba (LT) (785.86 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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magyar (HU) (880.68 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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Malti (MT) (902.28 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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Nederlands (NL) (805.75 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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norsk (NO) (756.66 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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polski (PL) (896.13 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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português (PT) (799.28 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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română (RO) (776.95 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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slovenčina (SK) (876.83 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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slovenščina (SL) (851.59 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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Suomi (FI) (767.12 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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svenska (SV) (763.56 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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Latest procedure affecting product information: IB/0003
14/08/2020
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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).

Qtrilmet : EPAR - All authorised presentations

English (EN) (506.63 KB - PDF)

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български (BG) (543.35 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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español (ES) (503.81 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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čeština (CS) (545.09 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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dansk (DA) (502.07 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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Deutsch (DE) (502.67 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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eesti keel (ET) (506.91 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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ελληνικά (EL) (550.23 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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français (FR) (503.59 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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hrvatski (HR) (558.01 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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íslenska (IS) (507.67 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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italiano (IT) (500.4 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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latviešu valoda (LV) (550.5 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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lietuvių kalba (LT) (506.55 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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magyar (HU) (534.93 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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Malti (MT) (544.54 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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Nederlands (NL) (497.07 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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norsk (NO) (506.04 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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polski (PL) (533.38 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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português (PT) (519.42 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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română (RO) (525.13 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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slovenčina (SK) (528.03 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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slovenščina (SL) (539.17 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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Suomi (FI) (516.21 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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svenska (SV) (506.43 KB - PDF)

First published: 10/12/2019Last updated: 09/10/2020
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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 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.

Authorisation details

EMA product number
EMEA/H/C/004910
Marketing authorisation holder
AstraZeneca AB

SE-151 85 Sodertalje
Sweden

Opinion adopted
19/09/2019
Marketing authorisation issued
11/11/2019
Revision
2

Assessment history

Qtrilmet : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (579.03 KB - PDF)

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Qtrilmet : EPAR - Public assessment report

AdoptedReference Number: EMA/524327/2019

English (EN) (2.58 MB - PDF)

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CHMP summary of positive opinion for Qtrilmet

AdoptedReference Number: EMA/CHMP/478963/2019

English (EN) (109.81 KB - PDF)

First published:
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