The marketing authorisation for Irbesartan BMS has been withdrawn at the request of the marketing authorisation holder.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
- 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
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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).