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BYLVAY (Ipsen Pty Ltd)
Product name
BYLVAY
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
127 (255 working days)
Active ingredients
odevixibat sesquihydrate
Registration type
EOI
Indication
BYLVAY is indicated for the treatment of cholestatic pruritus in Alagille syndrome (ALGS) 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.