The marketing authorisation for Thelin has been withdrawn at the request of the marketing authorisation holder.
Thelin : EPAR - Summary for the public (PDF/284.21 KB)
First published: 17/04/2007
Last updated: 02/03/2011
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|Date of issue of marketing authorisation valid throughout the European Union||
Kent CT13 9NJ
06/01/2011 Thelin - EMEA/H/C/000679 - T/0031
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).
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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.