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5 Current news of Actelion

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Tracleer receives label extension in the US


Actelion Ltd announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for Tracleer® (bosentan) to treat patients with mildly symptomatic WHO Functional Class II (FC II) pulmonary arterial hypertension (PAH). The U.S. FDA has ...


Tracleer (bosentan) receives EU approval for pediatric formulation

The first and only licensed pulmonary arterial hypertension therapy for children


Actelion Ltd announced that the pediatric dispersible formulation of Tracleer® (bosentan) for the treatment of pulmonary arterial hypertension (PAH) in children has been approved in the European Union. This approval makes Tracleer® the only PAH therapy with an approved pediatric formulation for ...


Bosentan (Tracleer) receives positive CHMP opinion for pediatric formulation


Actelion Ltd announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), issued a positive opinion for the pediatric formulation of bosentan (Tracleer®) for the treatment of pulmonary arterial hypertension (PAH). The ...


Positive study with Actelion's bosentan (Tracleer®) in CTEPH


Actelion Ltd announced the initial results from the double-blind, placebo-controlled, multicenter study BENEFiT (Bosentan Effects in Inoperable Forms of Chronic Thromboembolic Pulmonary Hypertension). The study met its primary objective, as treatment with bosentan (Tracleer®) was associated with ...


Tracleer Excellence Post Marketing Surveillance Programme (TRAX PMSTM) confirms long-term safety profile


Actelion Ltd announced that two abstracts presented at the European Society of Cardiology (ESC) conference confirm the long-term safety profile of Tracleer® (bosentan) in treating pulmonary arterial hypertension (PAH). Both abstracts comprise data from TRAX PMSTM, which was set up in the EU in ...


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