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 18/05/2018

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
7
Date of issue of marketing authorisation valid throughout the European Union
07/12/2011
Contact address
Dybendal Alle 10
2630 Taastruup
Denmark

Product information

20/03/2018 Edarbi - EMEA/H/C/002293 - IB/0022/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

Edarbi is indicated for the treatment of essential hypertension in adults.

Assessment history

Changes since initial authorisation of medicine

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