Zynquista

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Withdrawn

This medicine's authorisation has been withdrawn

sotagliflozin
Medicine Human Withdrawn
  • 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The European Public Assessment Report (EPAR) for Zynquista is updated to indicate that the marketing authorisation is no longer valid.

Zynquista : EPAR - Medicine overview

English (EN) (665.64 KB - PDF)

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български (BG) (759.4 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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español (ES) (663.54 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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čeština (CS) (739.92 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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dansk (DA) (661.62 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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Deutsch (DE) (665.21 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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eesti keel (ET) (660.61 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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ελληνικά (EL) (768.79 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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français (FR) (664.42 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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hrvatski (HR) (687.88 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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italiano (IT) (662 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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latviešu valoda (LV) (745.89 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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lietuvių kalba (LT) (690.02 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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magyar (HU) (732.62 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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Malti (MT) (747.05 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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Nederlands (NL) (662.97 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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polski (PL) (737.08 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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português (PT) (663.6 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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română (RO) (688.26 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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slovenčina (SK) (737.1 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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slovenščina (SL) (730.05 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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Suomi (FI) (661.18 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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svenska (SV) (662.66 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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Zynquista : EPAR - Risk-management-plan summary

English (EN) (720.08 KB - PDF)

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Product information

Zynquista : EPAR - Product information

English (EN) (1.18 MB - PDF)

First published: Last updated:
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български (BG) (2.39 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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español (ES) (1.23 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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čeština (CS) (2.05 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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dansk (DA) (1.2 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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Deutsch (DE) (1.25 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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eesti keel (ET) (1.23 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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ελληνικά (EL) (2.54 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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français (FR) (1.33 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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hrvatski (HR) (1.3 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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íslenska (IS) (1.19 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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italiano (IT) (1.3 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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latviešu valoda (LV) (2.11 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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lietuvių kalba (LT) (1.36 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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magyar (HU) (2.03 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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Malti (MT) (2.12 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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Nederlands (NL) (1.29 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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norsk (NO) (1.17 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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polski (PL) (2.08 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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português (PT) (1.21 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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română (RO) (1.43 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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slovenčina (SK) (2.03 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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slovenščina (SL) (1.95 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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Suomi (FI) (1.19 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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svenska (SV) (1.21 MB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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Latest procedure affecting product information:IAIN/0005
22/03/2022
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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).

Zynquista : EPAR - All Authorised presentations

English (EN) (593.92 KB - PDF)

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български (BG) (671.74 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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español (ES) (586.22 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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čeština (CS) (687.23 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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dansk (DA) (626.01 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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Deutsch (DE) (601.85 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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eesti keel (ET) (636.13 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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ελληνικά (EL) (631.56 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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français (FR) (594.11 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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hrvatski (HR) (636.11 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
View

íslenska (IS) (672.09 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
View

italiano (IT) (583.43 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
View

latviešu valoda (LV) (658.25 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
View

lietuvių kalba (LT) (88.55 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
View

magyar (HU) (651.75 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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Malti (MT) (623.33 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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Nederlands (NL) (663.01 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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norsk (NO) (599.37 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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polski (PL) (658.22 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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português (PT) (587.22 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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română (RO) (609.94 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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slovenčina (SK) (653.56 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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slovenščina (SL) (647.39 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
View

Suomi (FI) (667.97 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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svenska (SV) (595.78 KB - PDF)

First published: 16/05/2019 Last updated: 16/08/2022
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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 diabetes

Therapeutic 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.

Authorisation details

EMA product number
EMEA/H/C/004889
Marketing authorisation holder
Guidehouse Germany GmbH

Geschäftsanschrift
Albrechtstraße 10 c
10117 Berlin
Germany

Opinion adopted
27/02/2019
Marketing authorisation issued
26/04/2019
Withdrawal of marketing authorisation
22/03/2022
Revision
3

Assessment history

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

English (EN) (677.27 KB - PDF)

First published: Last updated:
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Zynquista : EPAR - Public assessment report

Adopted Reference Number: EMA/178275/2019

English (EN) (5.36 MB - PDF)

First published: Last updated:
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CHMP summary of positive opinion for Zynquista

Adopted Reference Number: EMA/CHMP/138211/2019

English (EN) (655.25 KB - PDF)

First published: Last updated:
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