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).
Apidra : EPAR - Summary for the public (PDF/47.82 KB)
First published: 27/07/2009
Last updated: 26/04/2010
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
sanofi-aventis Deutschland GmbH
|Date of issue of marketing authorisation valid throughout the European Union||
Sanofi-Aventis Deutschland GmbH
D-65926 Frankfurt am Main
09/12/2021 Apidra - EMEA/H/C/000557 - N/0089
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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).
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Drugs used in diabetes
Treatment of adults, adolescents and children, six years or older with diabetes mellitus, where treatment with insulin is required.