Abasaglar (previously Abasria)
insulin glargine
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Abasaglar. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Abasaglar.
For practical information about using Abasaglar, patients should read the package leaflet or contact their doctor or pharmacist.
-
List item
Abasaglar (previously Abasria) : EPAR - Medicine overview (PDF/124.21 KB)
First published: 14/10/2014
Last updated: 14/12/2020
EMA/434801/2020 -
-
List item
Abasaglar (previously Abasria) : EPAR - Risk-management-plan summary (PDF/46.03 KB)
First published: 14/10/2014
Last updated: 20/01/2015
Authorisation details
Product details | |
---|---|
Name |
Abasaglar (previously Abasria)
|
Agency product number |
EMEA/H/C/002835
|
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 |
Eli Lilly Nederland B.V.
|
Revision |
10
|
Date of issue of marketing authorisation valid throughout the European Union |
09/09/2014
|
Contact address |
Product information
23/07/2020 Abasaglar (previously Abasria) - EMEA/H/C/002835 - WS/1587
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
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.
Pharmacotherapeutic group
Drugs used in diabetes
Therapeutic indication
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.