Germany’s Expert Committee on Prescription, the SVA, has rejected applications to switch from Rx to OTC status erectile dysfunction drugs sildenafil (25mg) and tadalafil (10mg).
German Switch Committee Rejects Sildenafil And Tadalafil, Ball Now In Ministry’s Court
Germany’s Expert Committee on Prescription has gone against the wishes of the country's health ministry in rejecting Rx-to-OTC switch applications for sildenafil and tadalafil. The BMG could, in theory, ignore the SVA’s recommendation, however, such a move would be unprecedented.
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“Overall, no unexpected/new data or findings” were presented to Germany's Expert Committee for Prescription in the most recent Rx-to-OTC switch application for sildenafil (25mg and 50mg), according to medicines regulator BfArM, resulting in a third rejection in three years.
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