Thelin
Withdrawn
This medicine's authorisation has been withdrawn
sitaxentan sodium
MedicineHumanWithdrawn
- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 10 August 2006 the European Commission granted a marketing authorisation for the whole 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 CHMP 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 releases1 reflecting the current knowledge and discussions.
On 6 January 2011 the European Commission issued a decision confirming the withdrawal of the marketing authorization of Thelin.
Pursuant to this decision the European Public Assessment Report for Thelin is updated to reflect that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:
T/0031
06/01/2011
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
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).
Product details
- Name of medicine
- Thelin
- 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
Pharmacotherapeutic group
AntihypertensivesTherapeutic 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.
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