aliskiren hemifumarate / amlodipine besylate
The marketing authorisation for Rasilamlo has been withdrawn at the request of the marketing-authorisation holder.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
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Novartis Europharm Ltd
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25/06/2015 Rasilamlo - EMEA/H/C/002073 -
- 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
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.