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 28/09/2022

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
28
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

27/09/2022 Irbesartan Zentiva (previously Irbesartan Winthrop) - EMEA/H/C/000785 - IAIN/0097

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:

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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