Toujeo (previously Optisulin)
insulin glargine
Table of contents
Overview
Toujeo is a medicine used to control blood glucose (sugar) levels in adults and children from 6 years of age who have diabetes and need insulin.
It contains the active substance insulin glargine.
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List item
Toujeo : EPAR - Medicine overview (PDF/129.7 KB)
First published: 11/05/2009
Last updated: 03/12/2019
EMA/598962/2019 -
List item
Toujeo : EPAR - Risk Management Plan Summary (PDF/185.72 KB)
First published: 09/08/2023
Authorisation details
Product details | |
---|---|
Name |
Toujeo (previously Optisulin)
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Agency product number |
EMEA/H/C/000309
|
Active substance |
insulin glargine
|
International non-proprietary name (INN) or common name |
insulin glargine
|
Therapeutic area (MeSH) |
Diabetes Mellitus
|
Anatomical therapeutic chemical (ATC) code |
A10AE04
|
Publication details | |
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Marketing-authorisation holder |
Sanofi-aventis Deutschland GmbH
|
Revision |
33
|
Date of issue of marketing authorisation valid throughout the European Union |
26/06/2000
|
Contact address |
D-65926 Frankfurt am Main
Germany |
Product information
03/07/2023 Toujeo (previously Optisulin) - EMEA/H/C/000309 - WS2491
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
Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years.
Assessment history
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 14-17 October 201918/10/2019
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27/02/2015
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31/05/2013
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20/04/2012
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29/07/2009
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29/06/2009