Karvea
irbesartan
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Karvea. 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 Karvea.
Authorisation details
Product details | |
---|---|
Name |
Karvea
|
Agency product number |
EMEA/H/C/000142
|
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-aventis groupe
|
Revision |
40
|
Date of issue of marketing authorisation valid throughout the European Union |
26/08/1997
|
Contact address |
54 rue La Boétie
75008 Paris France |
Product information
14/01/2021 Karvea - EMEA/H/C/000142 - WS/1886/G
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
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