Irbesartan Hydrochlorothiazide BMS

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Withdrawn

This medicine's authorisation has been withdrawn

irbesartan / hydrochlorothiazide
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 19 January 2007 the European Commission issued a Marketing Authorisation valid throughout the European Union for the medicinal product Irbesartan Hydrochlorothiazide BMS (irbesartan/hydrochlorothiazide). Irbesartan Hydrochlorothiazide BMS is approved for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled on irbesartan or hydrochlorothiazide alone. The marketing authorisation holder (MAH) responsible for Irbesartan Hydrochlorothiazide BMS was Bristol-Myers Squibb Pharma EEIG. 

The European Commission was notified by letter dated 20 October 2009 of the MAH’s decision to voluntarily withdraw the Marketing Authorisation for Irbesartan Hydrochlorothiazide BMS for commercial reasons. Irbesartan Hydrochlorothiazide BMS has not been marketed anywhere in the European Union and there is no intention to market Irbesartan Hydrochlorothiazide BMS in the future. Irbesartan Hydrochlorothiazide BMS was an informed consent application to Karvezide. 

The MAH will maintain the Marketing Authorisation for another medicinal product containing irbesartan/hydrochlorothiazide, i.e. Karvezide. On 11 November 2009 the European Commission issued a decision to withdraw the Marketing Authorisation for Irbesartan Hydrochlorothiazide BMS. 

Pursuant to this decision the European Public Assessment Report for Irbesartan Hydrochlorothiazide BMS is updated to reflect that the Marketing Authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: N/0030
09/10/2009
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This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

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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Product details

Name of medicine
Irbesartan Hydrochlorothiazide BMS
Active substance
  • irbesartan
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
  • irbesartan
  • hydrochlorothiazide
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09DA04

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).

Authorisation details

EMA product number
EMEA/H/C/000784
Marketing authorisation holder
Bristol-Myers Squibb Pharma EEIG

Plaza 254
Blanchardstown Corporate Park 2
Dublin 15
D15 T867
Ireland

Marketing authorisation issued
19/01/2007
Withdrawal of marketing authorisation
11/11/2009
Revision
8

Assessment history

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