Sabervel

RSS

irbesartan

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Sabervel has expired following the marketing authorisation holder's decision not to apply for a renewal.

This EPAR was last updated on 29/06/2017

Authorisation details

Product details
Name
Sabervel
Agency product number
EMEA/H/C/002510
Active substance
irbesartan
International non-proprietary name (INN) or common name
irbesartan
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09CA04
GenericGeneric

This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

Publication details
Marketing-authorisation holder
Pharmathen S.A.
Revision
2
Date of issue of marketing authorisation valid throughout the European Union
13/04/2012
Contact address
6, Dervenakion
EL-15351 Pallini Attiki
Greece

Product information

04/09/2014 Sabervel - EMEA/H/C/002510 - A31/0005

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic 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

Changes since initial authorisation of medicine

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