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 21/03/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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
6
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

27/02/2018 Abasaglar (previously Abasria) - EMEA/H/C/002835 - T/0018

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.

Assessment history

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