Sabervel

Expired

This medicine's authorisation has expired

irbesartan

Overview

The marketing authorisation for Sabervel (irbesartan) expired on 17 April 2017 following the decision of the marketing authorisation holder, Pharmathen S.A., not to apply for a renewal of the marketing authorisation. Pharmathen S.A. confirmed that it did not apply for renewal of the authorisation due to commercial reasons. 

Sabervel was granted marketing authorisation in the European Union (EU) on 17 April 2012 for the treatment of essential hypertension and the treatment of renal disease in patients with hypertension and type 2 diabetes mellitus as part of an antihypertensive drug regimen. The marketing authorisation was valid for a 5-year period. Sabervel is a generic medicine of Aprovel. There are other generic medicinal products of Aprovel authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Sabervel is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

Sabervel : EPAR - Summary for the public

Product information

Sabervel : EPAR - Product Information

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 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.

Authorisation details

• EMA product number:
  EMEA/H/C/002510
• Generic:

  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.

• Marketing authorisation holder:
  Pharmathen S.A.

  6, Dervenakion; EL-15351 Pallini Attiki; Greece

• Marketing authorisation issued:
  13/04/2012
• Expiry of marketing authorisation:
  17/04/2017
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Sabervel : EPAR - Procedural steps taken and scientific information after authorisation

Sabervel-H-C-2510-A31-05 : EPAR - Assessment Report - Article 31

Adopted Reference Number: EMA/PRAC/294920/2014

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...

Initial marketing authorisation documents

Sabervel : EPAR - Public assessment report

Adopted Reference Number: EMA/225623/2012

CHMP summary of positive opinion for Sabervel

Adopted Reference Number: EMA/CHMP/101946/2012