Irbesartan Hydrochlorothiazide BMS

RSS

irbesartan / hydrochlorothiazide

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Irbesartan Hydrochlorothiazide BMS has been withdrawn at the request of the marketing authorisation holder.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
Name
Irbesartan Hydrochlorothiazide BMS
Agency product number
EMEA/H/C/000784
Active substance
  • irbesartan
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
  • irbesartan
  • hydrochlorothiazide
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09DA04
Publication details
Marketing-authorisation holder
Bristol-Myers Squibb Pharma EEIG
Revision
8
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

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

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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