Lusduna

RSS

insulin glargine

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Lusduna has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 22/01/2019

Authorisation details

Product details
Name
Lusduna
Agency product number
EMEA/H/C/004101
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
BiosimilarBiosimilar

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.

Publication details
Marketing-authorisation holder
Merck Sharp & Dohme B.V.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
03/01/2017
Contact address

Waarderweg 39
2031 BN Haarlem
The Netherlands

Product information

29/10/2018 Lusduna - EMEA/H/C/004101 - T/0006

Other EU languages available icon 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:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Drugs used in diabetes

Therapeutic indication

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

Assessment history

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