Hepludex CHMP Opinion for conditional marketing authorisation

Friday 22 April 2022

CHMP Opinion for 2^ndconditional marketing authorisation for Hepcludex.

MYR 301 Study Completion (Week 144) remains a Specific Obligation to the Conditional Marketing Authorisation

The Assessment of the MYR 301 Week 48 data (and relative SmPC updates) has been deferred to a separate Type II variation.