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BYLVAY Ipsen Pty Ltd
Product name
BYLVAY
Sponsor
Accepted date
Oct-2023
Active ingredients
odevixibat, odevixibat sesquihydrate
Proposed indication
For the treatment of progressive familial intrahepatic cholestasis (PFIC).
Application type
A (new medicine)
Publication date
Oct-2023
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.