Sprimeo HCT

RSS

aliskiren / hydrochlorothiazide

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Sprimeo HCT has been withdrawn at the request of the marketing-authorisation holder.

This EPAR was last updated on 28/08/2012

Authorisation details

Product details
Name
Sprimeo HCT
Agency product number
EMEA/H/C/002421
Active substance
  • aliskiren
  • hydrochlorothiazide
International non-proprietary name (INN) or common name
  • aliskiren
  • hydrochlorothiazide
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09XA52
Publication details
Marketing-authorisation holder
Novartis Europharm Ltd.
Revision
0
Date of issue of marketing authorisation valid throughout the European Union
23/06/2011
Contact address
Wimblehurst Road
Horsham
West Sussex
RH12 5AB
United Kingdom

Product information

06/07/2012 Sprimeo HCT - EMEA/H/C/002421 - -

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).

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Agents acting on the renin-angiotensin system

Therapeutic 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.

Assessment history

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