EMA's CHMP recommends approval of Revatio generic Granpidam (sildenafil) for pulmonary arterial hypertension- Accord Healthcare
The EMA's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Granpidam (sildenafil), from Accord Healthcare Ltd, intended for the treatment of pulmonary arterial hypertension. Granpidam will be available as 20 mg film-coated tablets.
Granpidam is a generic of Revatio, which has been authorised in the EU since 28 October 2005. Studies have demonstrated the satisfactory quality of Granpidam and its bioequivalence to Viagra, a sildenafil-containing medicine with the same qualitative composition as Revatio.
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