Levemir

RSS

insulin detemir

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Levemir. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Levemir.

This EPAR was last updated on 13/07/2021

Authorisation details

Product details
Name
Levemir
Agency product number
EMEA/H/C/000528
Active substance
Insulin detemir
International non-proprietary name (INN) or common name
insulin detemir
Therapeutic area (MeSH)
Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
A10AE05
Publication details
Marketing-authorisation holder
Novo Nordisk A/S
Revision
29
Date of issue of marketing authorisation valid throughout the European Union
01/06/2004
Contact address
Novo Allé
DK-2880 Bagsværd
Denmark

Product information

09/04/2021 Levemir - EMEA/H/C/000528 - II/0101

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 1 year and above.

Assessment history

Changes since initial authorisation of medicine

Related content

How useful was this page?

Add your rating
Average
2 ratings
2 ratings
1 rating
2 ratings