Tracleer

RSS

bosentan

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

Overview

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

Tracleer 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). Tracleer is given to reduce the number of new digital ulcers.

Tracleer contains the active substance bosentan.

This EPAR was last updated on 03/12/2019

Authorisation details

Product details
Name
Tracleer
Agency product number
EMEA/H/C/000401
Active substance
bosentan monohydrate
International non-proprietary name (INN) or common name
bosentan
Therapeutic area (MeSH)
  • Scleroderma, Systemic
  • Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code
C02KX01
Publication details
Marketing-authorisation holder
Janssen-Cilag International N V  
Revision
37
Date of issue of marketing authorisation valid throughout the European Union
14/05/2002
Contact address

Janssen-Cilag International N V
Turnhoutseweg 30
BE-2340 Beerse
Belgium

Product information

05/09/2019 Tracleer - EMEA/H/C/000401 - II/0092

Contents

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

Antihypertensives

Therapeutic indication

Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with 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.

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

Assessment history

Changes since initial authorisation of medicine

How useful was this page?

Add your rating
Average
1 rating
3 ratings