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Published on 11 March 2011

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EU Thelin withdrawal reflected in updated public assessment report

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The European public assessment report for Thelin has been updated to reflect that its marketing authorisation is no longer valid.

This follows the decision issued by the European Commission to withdraw marketing authorisation of Thelin on 6 January 2011.

On 10 August 2006 the European Commission granted a marketing authorisation for the European Union for Thelin (sitaxentan), an endothelin receptor antagonist used to treat adults (aged 18 years or over) with pulmonary arterial hypertension to improve exercise capacity (the ability to carry out physical activity) in patients with class III disease.

Thelin was marketed in 16 EU Member States.

Thelin had been known to be associated with liver toxicity and since its initial marketing authorisation had been contra-indicated in patients with mild to severe hepatic impairment (Child-Pugh Class A-C) and elevated aminotransferases prior to initiation of treatment.

On 12 December 2010, Pfizer, the marketing authorisation holder, requested the withdrawal of the marketing authorisation in the interest of patient safety.

The decision to withdraw was further to new information on two cases of fatal liver injury.

This matter was discussed at the Committee for Medicinal Products for Human use (CHMP) meeting in December 2010.

A transition plan was discussed and agreed with the marketing authorisation holder. The Agency published on 10 and 16 December 2010 two press releases reflecting the current knowledge and discussions



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