- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
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
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română (RO) (396.93 KB - PDF)
slovenčina (SK) (396.05 KB - PDF)
slovenščina (SL) (356.52 KB - PDF)
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svenska (SV) (268.58 KB - PDF)
Product information
Imprida HCT : EPAR - Product Information
English (EN) (4.04 MB - PDF)
български (BG) (8.15 MB - PDF)
español (ES) (4.13 MB - PDF)
čeština (CS) (6.17 MB - PDF)
dansk (DA) (4.24 MB - PDF)
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eesti keel (ET) (4.27 MB - PDF)
ελληνικά (EL) (8.33 MB - PDF)
français (FR) (4.45 MB - PDF)
íslenska (IS) (4.07 MB - PDF)
italiano (IT) (4.26 MB - PDF)
latviešu valoda (LV) (6.37 MB - PDF)
lietuvių kalba (LT) (4.62 MB - PDF)
magyar (HU) (6.42 MB - PDF)
Malti (MT) (6.75 MB - PDF)
Nederlands (NL) (4.11 MB - PDF)
norsk (NO) (4.14 MB - PDF)
polski (PL) (6.65 MB - PDF)
português (PT) (4.15 MB - PDF)
română (RO) (4.55 MB - PDF)
slovenčina (SK) (6.41 MB - PDF)
slovenščina (SL) (6.23 MB - PDF)
Suomi (FI) (4.16 MB - PDF)
svenska (SV) (4.13 MB - PDF)
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
Imprida HCT : EPAR - All Authorised presentations
English (EN) (20.74 KB - PDF)
български (BG) (396.01 KB - PDF)
español (ES) (268.27 KB - PDF)
čeština (CS) (356.37 KB - PDF)
dansk (DA) (265.53 KB - PDF)
Deutsch (DE) (267.75 KB - PDF)
eesti keel (ET) (268.84 KB - PDF)
ελληνικά (EL) (398.88 KB - PDF)
français (FR) (268.81 KB - PDF)
italiano (IT) (267.58 KB - PDF)
latviešu valoda (LV) (362.09 KB - PDF)
lietuvių kalba (LT) (330.83 KB - PDF)
magyar (HU) (373.98 KB - PDF)
Malti (MT) (357.51 KB - PDF)
Nederlands (NL) (266.04 KB - PDF)
polski (PL) (323.76 KB - PDF)
português (PT) (266.79 KB - PDF)
română (RO) (329.9 KB - PDF)
slovenčina (SK) (343.45 KB - PDF)
slovenščina (SL) (302.87 KB - PDF)
Suomi (FI) (268.72 KB - PDF)
svenska (SV) (260.58 KB - PDF)
Product details
- Name of medicine
- Imprida HCT
- Active substance
- amlodipine
- valsartan
- hydrochlorothiazide
- International non-proprietary name (INN) or common name
- amlodipine
- valsartan
- hydrochlorothiazide
- Therapeutic area (MeSH)
- Hypertension
- Anatomical therapeutic chemical (ATC) code
- C09DX01
Pharmacotherapeutic group
- Angiotensin II antagonists, plain
- Angiotensin II antagonists, combinations
Therapeutic indication
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.
Authorisation details
- EMA product number
- EMEA/H/C/001161
- Marketing authorisation holder
- Novartis Europharm Ltd.
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom - Marketing authorisation issued
- 15/10/2009
- Lapse of marketing authorisation
- 20/10/2012
- Revision
- 3
Assessment history
Imprida HCT : EPAR - Procedural steps taken and scientific information after authorisation
English (EN) (419.51 KB - PDF)
Imprida HCT : EPAR - Public assessment report
English (EN) (1.02 MB - PDF)
News on Imprida HCT
More information on Imprida HCT
Public statement on Imprida HCT: Cessation of validity of the marketing authorisation in the European Union
English (EN) (41.07 KB - PDF)
Questions and answers on the review of angiotensin-II-receptor antagonists and the risk of cancer
English (EN) (511.41 KB - PDF)