Irbesartan Zentiva (previously Irbesartan Winthrop)
irbesartan
Table of contents
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.
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 |
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:
- 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).
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
News
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28/06/2013
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17/05/2013
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 17-20 October 201121/10/2011
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20/10/2011
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24/04/2008