Overview
The marketing authorisation for Sabervel has expired following the marketing authorisation holder's decision not to apply for a renewal.
Sabervel : EPAR - Summary for the public
Product information
Sabervel : EPAR - Product Information
Latest procedure affecting product information: A31/0005
04/09/2014
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).
Sabervel : EPAR - All Authorised presentations
Product details
- Name of medicine
- Sabervel
- 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
Sabervel is indicated in adults for the treatment of essential hypertension.
It is also indicated for the treatment of renal disease in adult patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive medicinal product regimen.
Assessment history
Sabervel : EPAR - Procedural steps taken and scientific information after authorisation
Sabervel-H-C-2510-A31-05 : EPAR - Assessment Report - Article 31
Sabervel-H-C-2510-A31-05 : EPAR - Scientific conclusions, grounds for variation to the terms of the marketing authorisations and detailed explanation of the scientific grounds for the differences from the PRAC recommenda...