Edarbi

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azilsartan medoxomil

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 10/02/2021

Authorisation details

Product details
Name
Edarbi
Agency product number
EMEA/H/C/002293
Active substance
Azilsartan medoxomil
International non-proprietary name (INN) or common name
azilsartan medoxomil
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09CA09
Publication details
Marketing-authorisation holder
Takeda Pharma A/S
Revision
9
Date of issue of marketing authorisation valid throughout the European Union
07/12/2011
Contact address

Delta Park 45
2665 Vallensbaek Strand 
Denmark

Product information

19/01/2021 Edarbi - EMEA/H/C/002293 - IB/0029/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.

Assessment history

Changes since initial authorisation of medicine

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