This medicine is authorised for use in the European Union.


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 13/02/2023

Authorisation details

Product details
Agency product number
Active substance
bosentan (as monohydrate)
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Scleroderma, Systemic
  • Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Janssen-Cilag International N.V.  
Date of issue of marketing authorisation valid throughout the European Union
Contact address

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

Product information

09/02/2023 Tracleer - EMEA/H/C/000401 - WS/2404

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Product information documents contain:

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


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

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