insulin glulisine

This medicine is authorised for use in the European Union.


This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 27/06/2023

Authorisation details

Product details
Agency product number
Active substance
insulin glulisine
International non-proprietary name (INN) or common name
insulin glulisine
Therapeutic area (MeSH)
Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
sanofi-aventis Deutschland GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Sanofi-Aventis Deutschland GmbH
Brueningstrasse 50,
D-65926 Frankfurt am Main

Product information

26/06/2023 Apidra - EMEA/H/C/000557 - N/0091

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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 adults, adolescents and children, six years or older with diabetes mellitus, where treatment with insulin is required.

Assessment history

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