- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 15 October 2009, the European Commission granted a marketing authorisation valid throughout the European Union (EU) for the medicinal product Imprida HCT (amlodipine/valsartan/hydrochlorothiazide), indicated for the treatment of essential hypertension. The marketing authorisation holder was notified on the 19 October 2009.
Imprida HCT (amlodipine/valsartan/hydrochlorothiazide) had not been marketed in Europe since this initial marketing authorisation. In accordance with article 14(4) of Regulation (EC) No 726/2004 ('sunset clause'), the marketing authorisation of a medicinal product lapses if the product has never been marketed in one of the Member States within three years of its initial authorisation.
Because of this, from 20 October 2012, the marketing authorisation for Imprida HCT is no longer valid.
Pursuant to the expiry of the marketing authorisation, the European Assessment Report (EPAR) for Imprida HCT is updated to reflect that the marketing authorisation is no longer valid.
Product information
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).
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.