Sabervel

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Expired

This medicine's authorisation has expired

irbesartan
MedicineHumanExpired
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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Assessment Report (EPAR) for Sabervel is updated accordingly to reflect the fact that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: A31/0005
04/09/2014
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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).

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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

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