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Withdrawn
This medicine is now withdrawn from use in the European Union.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The marketing authorisation for Sprimeo HCT has been withdrawn at the request of the marketing-authorisation holder.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 - -

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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