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.
Levemir : EPAR - Summary for the public (PDF/86.75 KB)
First published: 06/08/2009
Last updated: 05/10/2015
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novo Nordisk A/S
|Date of issue of marketing authorisation valid throughout the European Union||
09/04/2021 Levemir - EMEA/H/C/000528 - II/0101
- Annex I - Summary of product characteristics
- Annex IIA - Manufacturing-authorisation holder responsible for batch release
- Annex IIB - Conditions of the marketing authorisation
- Annex IIIA - Labelling
- Annex IIIB - Package leaflet
Please note that the size of the above document can exceed 50 pages.
You are therefore advised to be selective about which sections or pages you wish to print.
Drugs used in diabetes
Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 September 201123/09/2011