Thelin
sitaxentan sodium
Table of contents
Overview
The marketing authorisation for Thelin has been withdrawn at the request of the marketing authorisation holder.
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
|
| 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
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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
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.