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Tracleer receives label extension in the US

10-Aug-2009

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 ...

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Tracleer (bosentan) receives EU approval for pediatric formulation

The first and only licensed pulmonary arterial hypertension therapy for children

07-Jul-2009

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 ...

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Bosentan (Tracleer) receives positive CHMP opinion for pediatric formulation

28-Apr-2009

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 ...

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

06-Mar-2007

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 ...

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

06-Sep-2005

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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