Aprovel

RSS

irbesartan

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Aprovel. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Aprovel.

This EPAR was last updated on 12/10/2022

Authorisation details

Product details
Name
Aprovel
Agency product number
EMEA/H/C/000141
Active substance
irbesartan
International non-proprietary name (INN) or common name
irbesartan
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09CA04
Publication details
Marketing-authorisation holder
Sanofi Winthrop Industrie
Revision
46
Date of issue of marketing authorisation valid throughout the European Union
26/08/1997
Contact address

Sanofi Winthrop Industrie
82 avenue Raspail
94250 Gentilly
France

Product information

11/10/2022 Aprovel - EMEA/H/C/000141 - IG1557

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Select ‘available languages’ to access the language you need.

 

Product information documents contain:

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

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.

Assessment history

Changes since initial authorisation of medicine

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