Toujeo (previously Optisulin)

RSS

insulin glargine

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European Public Assessment Report (EPAR) for Toujeo. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Toujeo.

This EPAR was last updated on 01/02/2018

Authorisation details

Product details
Name
Toujeo (previously Optisulin)
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
Marketing-authorisation holder
Sanofi-aventis Deutschland GmbH
Revision
24
Date of issue of marketing authorisation valid throughout the European Union
27/06/2000
Contact address
D-65926 Frankfurt am Main
Germany

Product information

26/10/2017 Toujeo (previously Optisulin) - EMEA/H/C/000309 - II/0100

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

DRUGS USED IN DIABETES

Therapeutic indication

Treatment of diabetes mellitus in adults, adolescents and children aged two years and above.

Assessment history

Changes since initial authorisation of medicine

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