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CHMP recommends marketing authorization for Glaxo’s hypertension drug

The Committee for Medicinal Products for Human Use or CHMP has recommended a marketing authorization for Glaxo Group's Volibris, 5mg and 10mg, film coated tablets intended for treatment of pulmonary arterial hypertension.

The active substance of Volibris is ambrisentan, an anti-hypertensives medicinal product (C02KX02). Volibris is indicated for the treatment of patients with pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity.