Apidra

RSS

insulin glulisine

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

Overview

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 14/05/2018

Authorisation details

Product details
Name
Apidra
Agency product number
EMEA/H/C/000557
Active substance
insulin glulisine
International non-proprietary name (INN) or common name
insulin glulisine
Therapeutic area (MeSH)
Diabetes Mellitus
Anatomical therapeutic chemical (ATC) code
A10AB06
Publication details
Marketing-authorisation holder
sanofi-aventis Deutschland GmbH
Revision
26
Date of issue of marketing authorisation valid throughout the European Union
27/09/2004
Contact address
Sanofi-Aventis Deutschland GmbH
Brueningstrasse 50,
D-65926 Frankfurt am Main
Germany

Product information

03/04/2018 Apidra - EMEA/H/C/000557 - IB/0077

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

Assessment history

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