Tracleer

RSS

bosentan

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

Overview

This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach its recommendations on how to use the medicine.

If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).

This EPAR was last updated on 01/02/2018

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
Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
Actelion Registration Ltd
Revision
32
Date of issue of marketing authorisation valid throughout the European Union
15/05/2002
Contact address
Gewerbestrasse 16
CH-4123 Allschwil
Switzerland

Product information

20/11/2017 Tracleer - EMEA/H/C/000401 - IG/0839

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

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

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