Thelin

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sitaxentan sodium

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Thelin has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 02/03/2011

Authorisation details

Product details
Name
Thelin
Agency product number
EMEA/H/C/000679
Active substance
sitaxentan sodium
International non-proprietary name (INN) or common name
sitaxentan sodium
Therapeutic area (MeSH)
Hypertension, Pulmonary
Anatomical therapeutic chemical (ATC) code
C02KX03
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
Pfizer Ltd.
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
10/08/2006
Contact address
Ramsgate Road
Sandwich
Kent CT13 9NJ
United Kingdom

Product information

06/01/2011 Thelin - EMEA/H/C/000679 - T/0031

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 patients with pulmonary arterial hypertension (PAH) classified as WHO functional class III, to improve exercise capacity. Efficacy has been shown in primary pulmonary hypertension and in pulmonary hypertension associated with connective tissue disease.

Assessment history

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