Stayveer

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bosentan monohydrate

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for Stayveer. It explains how the Agency assessed the medicine to recommend its authorisation in the European Union (EU) and its conditions of use. It is not intended to provide practical advice on how to use Stayveer.

For practical information about using Stayveer, patients should read the package leaflet or contact their doctor or pharmacist.

This EPAR was last updated on 29/09/2017

Authorisation details

Product details
Name
Stayveer
Agency product number
EMEA/H/C/002644
Active substance
bosentan monohydrate
International non-proprietary name (INN) or common name
bosentan monohydrate
Therapeutic area (MeSH)
  • Hypertension, Pulmonary
  • Scleroderma, Systemic
Anatomical therapeutic chemical (ATC) code
C02KX01
Publication details
Marketing-authorisation holder
Marklas Nederlands BV   
Revision
7
Date of issue of marketing authorisation valid throughout the European Union
24/06/2013
Contact address
Marklas Nederlands BV
Beneluxlaan 2b
3446 GR Woerden
The Netherlands

Product information

26/09/2017 Stayveer - EMEA/H/C/002644 - PSUSA/425/201611

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

Other antihypertensive drugs

Therapeutic indication

Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with World Health Organization (WHO) functional class III. Efficacy has been shown in:

  • primary (idiopathic and familial) PAH;
  • PAH secondary to scleroderma without significant interstitial pulmonary disease;
  • PAH associated with congenital systemic-to-pulmonary shunts and Eisenmenger’s physiology.

Some improvements have also been shown in patients with PAH WHO functional class II.

Stayveer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital-ulcer disease.

Assessment history

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