Toujeo (previously Optisulin)

insulin glargine

Opinion

On 17 October 2019, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Toujeo. The marketing authorisation holder for this medicinal product is Sanofi-Aventis Deutschland GmbH.

The CHMP adopted a change to the existing indication as follows:1

“Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years”.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

1 New text in bold

Key facts

Name
Toujeo (previously Optisulin)
Agency product number
EMEA/H/C/000309
International non-proprietary name (INN) or common name
  • insulin glargine
Active substance
  • insulin glargine
Therapeutic area
Diabetes Mellitus
Date opinion adopted
17/10/2019
Company name
Sanofi-aventis Deutschland GmbH
Status
Positive
Application type
Post-authorisation

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