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BYLVAY (Ipsen Pty Ltd)
Product name
BYLVAY
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
107 (255 working days)
Active ingredients
odevixibat, odevixibat sesquihydrate
Registration type
NCE/ NBE
Indication
BYLVAY is indicated for the treatment of progressive familial intrahepatic cholestasis (PFIC) in patients aged 6 months or older.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.