Stayveer

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bosentan monohydrate

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

Overview

Stayveer is used to treat patients with class III pulmonary arterial hypertension (PAH) to improve exercise capacity (the ability to carry out physical activity) and reduce symptoms. PAH is abnormally high blood pressure in the arteries of the lungs. The ‘class’ reflects the severity of the disease: ‘class III’ PAH involves marked limitation of physical activity. The PAH can be:

  • primary (with no identified cause or inherited);
  • caused by scleroderma (also called systemic sclerosis, a disease where there is abnormal growth of the connective tissue that supports the skin and other organs);
  • caused by congenital (inborn) heart defects with shunts (abnormal passageways) causing abnormal flow of blood through the heart and

Some improvement with Stayveer can also occur in patients with class II PAH. ‘Class II’ involves slight limitation of physical activity.

Stayveer can also be used in adults with systemic sclerosis in whom poor blood circulation caused by the disease has led to the development of digital ulcers (sores on the fingers and toes). Stayveer is given to reduce the number of new digital ulcers.

Stayveer contains the active substance bosentan. This medicine is the same as Tracleer, which is already authorised in the EU. The company that makes Tracleer has agreed that its scientific data can be used for Stayveer (‘informed consent’).

This EPAR was last updated on 08/05/2020

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
Janssen-Cilag International NV
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
24/06/2013
Contact address

Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

10/04/2020 Stayveer - EMEA/H/C/002644 - IAIN/0031/G

Contents

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Pharmacotherapeutic group

Other antihypertensives

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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