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.
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Abasaglar (previously Abasria) : EPAR - Medicine overview (PDF/124.21 KB)
First published: 14/10/2014
Last updated: 14/12/2020
EMA/434801/2020 -
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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 | |
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Marketing-authorisation holder |
Eli Lilly Nederland B.V.
|
Revision |
12
|
Date of issue of marketing authorisation valid throughout the European Union |
09/09/2014
|
Contact address |
Papendorpseweg 83 |
Product information
10/09/2021 Abasaglar (previously Abasria) - EMEA/H/C/002835 - N/0037
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.