Abasaglar (previously Abasria)

RSS

insulin glargine

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

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.

This EPAR was last updated on 24/09/2021

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
BiosimilarBiosimilar

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
12
Date of issue of marketing authorisation valid throughout the European Union
09/09/2014
Contact address

Papendorpseweg 83
3528 BJ Utrecht
The Netherlands

Product information

10/09/2021 Abasaglar (previously Abasria) - EMEA/H/C/002835 - N/0037

Other EU languages available icon 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:

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.

Assessment history

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