SOHONOS (Ipsen Pty Ltd)
Product name
SOHONOS
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
202 (255 working days)
Active ingredients
palovarotene
Registration type
NCE/NBE
Indication
SOHONOS is indicated to reduce the formation of heterotopic ossification in adults and children aged 8 years and above for females and 10 years and above for males with fibrodysplasia ossificans progressiva (FOP).
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.