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Pharmaceuticals - Community Register
List of nationally authorised medicinal products for human use
|Indication:||Treatment of pulmonary arterial hypertension (PAH) to improve exercise capacity and symptoms in patients with WHO functional class III. Efficacy has been shown in:|
• Primary (idiopathic and heritable) pulmonary arterial hypertension
• Pulmonary arterial hypertension secondary to scleroderma without significant interstitial pulmonary disease
• Pulmonary arterial hypertension associated with congenital systemic-to-pulmonary shunts and Eisenmenger’s physiology
Some improvements have also been shown in patients with pulmonary arterial hypertension WHO functional class II.
Tracleer is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
|Marketing Authorisation Holder:||Not applicable|
|Close date procedure||Procedure type||EMEA number||Decision||summary publ||decision docs||annex|
|01/09/2015||PSUSA - Modification||EMEA/H/C/PSUSA/425/201411||(2015)6117 of 28/08/2015|
|07/10/2016||PSUSA - Modification||EMEA/H/C/PSUSA/425/201511||(2016)6543 of 06/10/2016|
|19/09/2017||PSUSA - Modification||EMEA/H/C/PSUSA/425/201611||(2017) 6435 of 18/09/2017|