Sprimeo HCT
Withdrawn
This medicine's authorisation has been withdrawn
aliskiren / hydrochlorothiazide
Medicine
Human
Withdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 23 June 2011 the European Commission issued a marketing authorisation valid throughout the European Union for the medicinal product Sprimeo HCT (aliskiren/hydrochlorothiazide). Sprimeo HCT was approved for the treatment of essential hypertension. The marketing authorisation holder (MAH) responsible for Sprimeo HCT was Novartis Europharm Ltd.
The European Commission was notified by letter dated 10 June 2012 of the MAH’s decision to voluntarily withdraw the marketing authorisation for Sprimeo HCT for commercial reasons. On 6 July 2012 the European Commission issued a decision to withdraw the marketing authorisation for Sprimeo HCT.
Pursuant to this decision the European Public Assessment Report for Sprimeo HCT is updated to reflect the fact that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:-
06/07/2012
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
- Sprimeo HCT
- Active substance
- aliskiren
- hydrochlorothiazide
- International non-proprietary name (INN) or common name
- aliskiren
- hydrochlorothiazide
- Therapeutic area (MeSH)
- Hypertension
- Anatomical therapeutic chemical (ATC) code
- C09XA52
Pharmacotherapeutic group
Agents acting on the renin-angiotensin systemTherapeutic indication
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.
News on Sprimeo HCT
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