Lusduna

Withdrawn

This medicine's authorisation has been withdrawn

insulin glargine

Overview

On 29 October 2018, the European Commission withdrew the marketing authorisation for Lusduna (insulin glargine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Merck Sharp & Dohme B.V., which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Lusduna is a biosimilar medicine of Lantus. It was granted marketing authorisation in the EU on 4 January 2017 for treatment of diabetes mellitus. The product has never been marketed in the EU. 

The European Public Assessment Report (EPAR) for Lusduna is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Lusduna : EPAR - Summary for the public

Product information

Lusduna : EPAR - Product Information

Lusduna : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Lusduna
• 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

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.

Authorisation details

• EMA product number:
  EMEA/H/C/004101
• 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:
  Merck Sharp & Dohme B.V.

  Waarderweg 39; 2031 BN Haarlem; The Netherlands

• Opinion adopted:
  09/11/2016
• Marketing authorisation issued:
  03/01/2017
• Withdrawal of marketing authorisation:
  29/10/2018
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

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

Initial marketing authorisation documents

Lusduna : EPAR - Public assessment report

AdoptedReference Number: EMA/813309/2016

CHMP summary of positive opinion for Lusduna

AdoptedReference Number: EMA/CHMP/706807/2016