Sprimeo

RSS

aliskiren

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Sprimeo has been withdrawn at the request of the marketing-authorisation holder.

 

This EPAR was last updated on 23/07/2012

Authorisation details

Product details
Name
Sprimeo
Agency product number
EMEA/H/C/000851
Active substance
aliskiren
International non-proprietary name (INN) or common name
aliskiren
Therapeutic area (MeSH)
Hypertension
Anatomical therapeutic chemical (ATC) code
C09XA02
Publication details
Marketing-authorisation holder
Novartis Europharm Ltd.
Revision
5
Date of issue of marketing authorisation valid throughout the European Union
22/08/2007
Contact address
Novartis Europharm Limited
Wimblehurst Road
Horsham
West Sussex, RH12 5AB
United Kingdom

Product information

04/07/2012 Sprimeo - EMEA/H/C/000851 - II/0039

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.

Assessment history

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