Overview

The marketing authorisation for Qtrilmet has been withdrawn at the request of the marketing-authorisation holder.

Qtrilmet : EPAR - Medicine overview

Reference Number: EMA/521799/2019

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български (BG) (626.71 KB - PDF)

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čeština (CS) (618.79 KB - PDF)

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dansk (DA) (578.96 KB - PDF)

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Deutsch (DE) (582.95 KB - PDF)

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eesti keel (ET) (567.57 KB - PDF)

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ελληνικά (EL) (625.56 KB - PDF)

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français (FR) (580.79 KB - PDF)

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hrvatski (HR) (602.92 KB - PDF)

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italiano (IT) (578.63 KB - PDF)

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latviešu valoda (LV) (636.06 KB - PDF)

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lietuvių kalba (LT) (602.67 KB - PDF)

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magyar (HU) (615.63 KB - PDF)

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Malti (MT) (618.89 KB - PDF)

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Nederlands (NL) (578.78 KB - PDF)

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polski (PL) (620.12 KB - PDF)

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português (PT) (580.04 KB - PDF)

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română (RO) (601.67 KB - PDF)

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slovenčina (SK) (618.69 KB - PDF)

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slovenščina (SL) (615.88 KB - PDF)

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Suomi (FI) (578.75 KB - PDF)

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svenska (SV) (578.25 KB - PDF)

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Qtrilmet : EPAR - Risk-management-plan summary

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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)

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español (ES) (784.26 KB - PDF)

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čeština (CS) (872.45 KB - PDF)

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dansk (DA) (775.74 KB - PDF)

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Deutsch (DE) (809.2 KB - PDF)

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eesti keel (ET) (753.19 KB - PDF)

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ελληνικά (EL) (929.34 KB - PDF)

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français (FR) (808.14 KB - PDF)

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hrvatski (HR) (761.11 KB - PDF)

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íslenska (IS) (769.8 KB - PDF)

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italiano (IT) (851.09 KB - PDF)

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latviešu valoda (LV) (857.92 KB - PDF)

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lietuvių kalba (LT) (785.86 KB - PDF)

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magyar (HU) (880.68 KB - PDF)

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Malti (MT) (902.28 KB - PDF)

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Nederlands (NL) (805.75 KB - PDF)

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norsk (NO) (756.66 KB - PDF)

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polski (PL) (896.13 KB - PDF)

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português (PT) (799.28 KB - PDF)

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română (RO) (776.95 KB - PDF)

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slovenčina (SK) (876.83 KB - PDF)

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slovenščina (SL) (851.59 KB - PDF)

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Suomi (FI) (767.12 KB - PDF)

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svenska (SV) (763.56 KB - PDF)

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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)

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eesti keel (ET) (506.91 KB - PDF)

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ελληνικά (EL) (550.23 KB - PDF)

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français (FR) (503.59 KB - PDF)

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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)

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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)

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magyar (HU) (534.93 KB - PDF)

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Malti (MT) (544.54 KB - PDF)

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Nederlands (NL) (497.07 KB - PDF)

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norsk (NO) (506.04 KB - PDF)

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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)

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Public statement on Qtrilmet: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/486077/2020

English (EN) (130.22 KB - PDF)

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