Prodotti GS / Area Liver
Hepludex CHMP Opinion for conditional marketing authorisation
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Friday 22 April 2022
CHMP Opinion for 2ndconditional 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.
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