- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
The marketing authorisation for Irbesartan BMS has been withdrawn at the request of the marketing authorisation holder.
Product information
Latest procedure affecting product information:
II/0018
07/04/2009
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).
Product details
- Name of medicine
- Irbesartan BMS
- Active substance
- irbesartan
- International non-proprietary name (INN) or common name
- irbesartan
- Therapeutic area (MeSH)
- Hypertension
- Anatomical therapeutic chemical (ATC) code
- C09CA04
Pharmacotherapeutic group
Agents acting on the renin-angiotensin systemTherapeutic 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).
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