Irbesartan BMS

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irbesartan

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Irbesartan BMS has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 26/11/2009

Authorisation details

Product details
Name
Irbesartan BMS
Agency product number
EMEA/H/C/000786
Active substance
irbesartan
International non-proprietary name (INN) or common name
irbesartan
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09CA04
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
19/01/2007
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Product information

07/04/2009 Irbesartan BMS - EMEA/H/C/000786 - II/0018

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

Agents acting on the renin-angiotensin system

Therapeutic indication

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).

Assessment history

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