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Both medicines are unlicensed in the UK, meaning they cannot be prescribed through standard NHS or private prescribing routes

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The supplemental approval was granted based on data from the Phase III EMBARK trial, which studied Xtandi plus leuprolide, placebo plus leuprolide (a synthetic hormone regulator) and Xtandi as a monotherapy

These ingredients are not part of a USP/NGF monograph or an approved drug product