Overview

The marketing authorisation for Zynquista has been withdrawn at the request of the marketing-authorisation holder.

Zynquista : EPAR - Medicine overview

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eesti keel (ET) (660.61 KB - PDF)

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hrvatski (HR) (687.88 KB - PDF)

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italiano (IT) (662 KB - PDF)

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latviešu valoda (LV) (745.89 KB - PDF)

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lietuvių kalba (LT) (690.02 KB - PDF)

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magyar (HU) (732.62 KB - PDF)

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Malti (MT) (747.05 KB - PDF)

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Nederlands (NL) (662.97 KB - PDF)

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polski (PL) (737.08 KB - PDF)

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português (PT) (663.6 KB - PDF)

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română (RO) (688.26 KB - PDF)

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slovenčina (SK) (737.1 KB - PDF)

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slovenščina (SL) (730.05 KB - PDF)

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Suomi (FI) (661.18 KB - PDF)

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svenska (SV) (662.66 KB - PDF)

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Zynquista : EPAR - Risk-management-plan summary

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Product information

Zynquista : EPAR - Product information

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čeština (CS) (2.05 MB - PDF)

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dansk (DA) (1.2 MB - PDF)

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Deutsch (DE) (1.25 MB - PDF)

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eesti keel (ET) (1.23 MB - PDF)

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ελληνικά (EL) (2.54 MB - PDF)

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français (FR) (1.33 MB - PDF)

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hrvatski (HR) (1.3 MB - PDF)

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íslenska (IS) (1.19 MB - PDF)

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italiano (IT) (1.3 MB - PDF)

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latviešu valoda (LV) (2.11 MB - PDF)

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lietuvių kalba (LT) (1.36 MB - PDF)

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magyar (HU) (2.03 MB - PDF)

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Malti (MT) (2.12 MB - PDF)

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Nederlands (NL) (1.29 MB - PDF)

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norsk (NO) (1.17 MB - PDF)

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polski (PL) (2.08 MB - PDF)

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português (PT) (1.21 MB - PDF)

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română (RO) (1.43 MB - PDF)

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slovenčina (SK) (2.03 MB - PDF)

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slovenščina (SL) (1.95 MB - PDF)

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Suomi (FI) (1.19 MB - PDF)

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svenska (SV) (1.21 MB - PDF)

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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.
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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).

Zynquista : EPAR - All Authorised presentations

English (EN) (593.92 KB - PDF)

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български (BG) (671.74 KB - PDF)

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español (ES) (586.22 KB - PDF)

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čeština (CS) (687.23 KB - PDF)

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dansk (DA) (626.01 KB - PDF)

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Deutsch (DE) (601.85 KB - PDF)

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eesti keel (ET) (636.13 KB - PDF)

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ελληνικά (EL) (631.56 KB - PDF)

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français (FR) (594.11 KB - PDF)

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hrvatski (HR) (636.11 KB - PDF)

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íslenska (IS) (672.09 KB - PDF)

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italiano (IT) (583.43 KB - PDF)

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latviešu valoda (LV) (658.25 KB - PDF)

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lietuvių kalba (LT) (88.55 KB - PDF)

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magyar (HU) (651.75 KB - PDF)

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Malti (MT) (623.33 KB - PDF)

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Nederlands (NL) (663.01 KB - PDF)

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norsk (NO) (599.37 KB - PDF)

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polski (PL) (658.22 KB - PDF)

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português (PT) (587.22 KB - PDF)

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română (RO) (609.94 KB - PDF)

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slovenčina (SK) (653.56 KB - PDF)

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slovenščina (SL) (647.39 KB - PDF)

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Suomi (FI) (667.97 KB - PDF)

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svenska (SV) (595.78 KB - PDF)

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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
Revision
3

Assessment history

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

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Zynquista : EPAR - Public assessment report

AdoptedReference Number: EMA/178275/2019

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CHMP summary of positive opinion for Zynquista

AdoptedReference Number: EMA/CHMP/138211/2019

English (EN) (655.25 KB - PDF)

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More information on Zynquista

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

Reference Number: EMA/275660/2022

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