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.
Edarbi : EPAR - Summary for the public (PDF/77.72 KB)
First published: 15/12/2011
Last updated: 13/07/2015
Edarbi : EPAR - Risk-management-plan summary (PDF/48.93 KB)
First published: 18/03/2020
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Takeda Pharma A/S
|Date of issue of marketing authorisation valid throughout the European Union||
08/01/2020 Edarbi - EMEA/H/C/002293 - N/0026
- 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
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Agents acting on the renin-angiotensin system
Edarbi is indicated for the treatment of essential hypertension in adults.