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OPFOLDA Amicus Therapeutics Pty Ltd
Product name
OPFOLDA
Sponsor
Accepted date
Jan-2024
Active ingredients
miglustat
Proposed indication
An enzyme stabiliser of POMBILITI (cipaglucosidase alfa) long-term enzyme replacement therapy in adults with late-onset Pompe disease (acid α-glucosidase [GAA] deficiency).
Application type
C (new indication)
Publication date
Jan-2024