Irbesartan Zentiva (previously Irbesartan Winthrop)

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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 Irbesartan Zentiva. 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 Irbesartan Zentiva.

This EPAR was last updated on 22/05/2019

Authorisation details

Product details
Name
Irbesartan Zentiva (previously Irbesartan Winthrop)
Agency product number
EMEA/H/C/000785
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
Zentiva k.s.
Revision
21
Date of issue of marketing authorisation valid throughout the European Union
19/01/2007
Contact address

U kabelovny 130
Dolni Mecholupy
102 37 Prague 10
Czech Republic

Product information

02/04/2019 Irbesartan Zentiva (previously Irbesartan Winthrop) - EMEA/H/C/000785 - A31/0080

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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