Levemir
insulin detemir
Table of contents
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 19/10/2020
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 |
28
|
Date of issue of marketing authorisation valid throughout the European Union |
01/06/2004
|
Contact address |
Product information
24/09/2020 Levemir - EMEA/H/C/000528 - WS/1901
Contents
- 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
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Pharmacotherapeutic group
Pharmacotherapeutic group
Drugs used in diabetes
Therapeutic indication
Therapeutic indication
Treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.