This is a summary of the European public assessment report (EPAR) for Rasilez. 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 Rasilez.
Rasilez : EPAR - Summary for the public (PDF/78.75 KB)
First published: 07/05/2009
Last updated: 18/08/2016
Rasilez : EPAR - Risk-management-plan summary (PDF/146.97 KB)
First published: 23/01/2023
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Noden Pharma DAC
|Date of issue of marketing authorisation valid throughout the European Union||
16A D'Olier Street
23/02/2023 Rasilez - EMEA/H/C/000780 - IAIN/0131
This medicine’s product information is available in all official EU languages.
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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.
Agents acting on the renin-angiotensin system
Treatment of essential hypertension.