bosentan monohydrate

This medicine is authorised for use in the European Union.


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 16/10/2019

Authorisation details

Product details
Agency product number
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
Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Turnhoutseweg, 30
B-2340 Beerse

Product information

05/09/2019 Stayveer - EMEA/H/C/002644 - II/0028


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

How useful was this page?

Add your rating