Lusduna
insulin glargine
Table of contents
Overview
The marketing authorisation for Lusduna has been withdrawn at the request of the marketing-authorisation holder.
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
|
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. |
| 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 |
Product information
29/10/2018 Lusduna - EMEA/H/C/004101 - T/0006
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).
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.