aliskiren / hydrochlorothiazide
The marketing authorisation for Sprimeo HCT has been withdrawn at the request of the marketing-authorisation holder.
Sprimeo HCT : EPAR - Summary for the public (PDF/258.69 KB)
First published: 07/09/2011
Last updated: 28/08/2012
|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||
06/07/2012 Sprimeo HCT - EMEA/H/C/002421 - -
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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
Treatment of essential hypertension in adults.
Sprimeo HCT is indicated in patients whose blood pressure is not adequately controlled on aliskiren or hydrochlorothiazide used alone.
Sprimeo HCT is indicated as substitution therapy in patients adequately controlled with aliskiren and hydrochlorothiazide, given concurrently, at the same dose level as in the combination.