Truvelog Mix 30

Withdrawn

This medicine's authorisation has been withdrawn

insulin aspart

Overview

On 25 January 2024, the European Commission withdrew the marketing authorisation for Truvelog Mix 30 (insulin aspart) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Sanofi Winthrop Industrie, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.

Truvelog Mix 30 was granted marketing authorisation in the EU on 25 April 2022 for the treatment of diabetes mellitus.

The European Public Assessment Report (EPAR) for Truvelog Mix 30 will be updated to indicate that the marketing authorisation is no longer valid.

Truvelog Mix 30 : EPAR - Summary for the public

Reference Number: EMA/125308/2022

Truvelog Mix 30 : EPAR - Risk-management-plan summary

Product information

Truvelog Mix 30 : EPAR - Product Information

Truvelog Mix 30 : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Truvelog Mix 30
• Active substance:
  insulin aspart
• International non-proprietary name (INN) or common name:
  insulin aspart
• Therapeutic area (MeSH):
  Diabetes Mellitus
• Anatomical therapeutic chemical (ATC) code:
  A10AD05

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Truvelog Mix 30 is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 10 years and above.

Authorisation details

• EMA product number:
  EMEA/H/C/005635
• Biosimilar:

  This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

• Marketing authorisation holder:
  Sanofi Winthrop Industrie

  82 Avenue Raspail; 94250 Gentilly; FRANCE

• Opinion adopted:
  24/02/2022
• Marketing authorisation issued:
  25/04/2022
• Withdrawal of marketing authorisation:
  25/01/2024
• Revision:
  3

Assessment history

Changes since initial authorisation of medicine

Truvelog Mix 30 : EPAR - Procedural steps taken and scientific information after authorisation

Initial marketing authorisation documents

Truvelog Mix 30 : EPAR - Public assessment report

Adopted Reference Number: EMA/165165/2022

CHMP summary of positive opinion for Truvelog Mix 30

Adopted Reference Number: EMA/CHMP/83437/2022