Lusduna

Withdrawn

This medicine's authorisation has been withdrawn

insulin glargine

Overview

The marketing authorisation for Lusduna has been withdrawn at the request of the marketing-authorisation holder.

Lusduna : EPAR - Summary for the public

Product information

Lusduna : EPAR - Product Information

Latest procedure affecting product information: T/0006

29/10/2018

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).

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
• 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