Irbesartan Hydrochlorothiazide BMS
Withdrawn
This medicine's authorisation has been withdrawn
irbesartan / hydrochlorothiazide
MedicineHumanWithdrawn
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- 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Assessment Report for Irbesartan Hydrochlorothiazide BMS is updated to reflect that the Marketing Authorisation is no longer valid.
Product information
Latest procedure affecting product information:N/0030
09/10/2009
This medicine’s product information is available in all official EU languages.
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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).
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 systemTherapeutic 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).
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