Edarbi
azilsartan medoxomil
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Edarbi. 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 Edarbi.
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List item
Edarbi : EPAR - Summary for the public (PDF/77.72 KB)
First published: 15/12/2011
Last updated: 13/07/2015
EMA/807101/2011 -
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List item
Edarbi : EPAR - Risk-management-plan summary (PDF/48.93 KB)
First published: 18/03/2020
Authorisation details
Product details | |
---|---|
Name |
Edarbi
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Agency product number |
EMEA/H/C/002293
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Active substance |
Azilsartan medoxomil
|
International non-proprietary name (INN) or common name |
azilsartan medoxomil
|
Therapeutic area (MeSH) |
Hypertension
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Anatomical therapeutic chemical (ATC) code |
C09CA09
|
Publication details | |
---|---|
Marketing-authorisation holder |
Takeda Pharma A/S
|
Revision |
10
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Date of issue of marketing authorisation valid throughout the European Union |
07/12/2011
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Contact address |
Delta Park 45 |
Product information
24/02/2022 Edarbi - EMEA/H/C/002293 - II/0030/G
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
Edarbi is indicated for the treatment of essential hypertension in adults.