Irbesartan Hydrochlorothiazide BMS


irbesartan / hydrochlorothiazide

This medicine is now withdrawn from use in the European Union.


The marketing authorisation for Irbesartan Hydrochlorothiazide BMS has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 24/11/2009

Authorisation details

Product details
Irbesartan Hydrochlorothiazide BMS
Agency product number
Active substance
  • irbesartan
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
  • irbesartan
  • hydrochlorothiazide
Therapeutic area (MeSH)
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867

Product information

09/10/2009 Irbesartan Hydrochlorothiazide BMS - EMEA/H/C/000784 - N/0030

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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).

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.
This fixed dose combination is indicated in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone (see section 5.1).

Assessment history

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