Table of contents
The marketing authorisation for Irbesartan BMS has been withdrawn at the request of the marketing authorisation holder.
Irbesartan BMS : EPAR - Summary for the public (PDF/271.51 KB)
First published: 26/11/2009
Last updated: 26/11/2009
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Bristol-Myers Squibb Pharma EEIG
|Date of issue of marketing authorisation valid throughout the European Union||
07/04/2009 Irbesartan BMS - EMEA/H/C/000786 - II/0018
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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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Agents acting on the renin-angiotensin system
Treatment of essential hypertension.
Treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen (see section 5.1).