aliskiren hemifumarate / amlodipine besilate
The marketing authorisation for Rasilamlo has been withdrawn at the request of the marketing-authorisation holder.
Rasilamlo : EPAR - Summary for the public (PDF/547.33 KB)
First published: 06/06/2011
Last updated: 28/03/2017
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Novartis Europharm Ltd
|Date of issue of marketing authorisation valid throughout the European Union||
25/06/2015 Rasilamlo - EMEA/H/C/002073 -
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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).
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Agents acting on the renin-angiotensin system
Rasilamlo is indicated for the treatment of essential hypertension in adult patients whose blood pressure is not adequately controlled with aliskiren or amlodipine used alone.