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.