amlodipine / valsartan / hydrochlorothiazide
The marketing authorisation for Imprida HCT has lapsed because it has not been marketed in the European Union in the three years following the granting of the authorisation.
Imprida HCT : EPAR - Summary for the public (PDF/288.49 KB)
First published: 12/11/2009
Last updated: 29/10/2012
|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||
Novartis Europharm Limited
West Sussex, RH12 5AB
20/10/2012 Imprida HCT - EMEA/H/C/001161 - WS/0250/G
- 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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Angiotensin II antagonists, plain
Angiotensin II antagonists, combinations
Treatment of essential hypertension as substitution therapy in adult patients whose blood pressure is adequately controlled on the combination of amlodipine, valsartan and hydrochlorothiazide (HCT), taken either as three single-component formulations or as a dual-component and a single-component formulation.