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POMBILITI (Amicus Therapeutics Pty Ltd)
Product name
POMBILITI
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
191 (255 working days)
Active ingredients
cipaglucosidase alfa
Registration type
NCE/ NBE
Indication
POMBILITI (cipaglucosidase alfa) is a long-term enzyme replacement therapy used in combination with the enzyme stabiliser miglustat for the treatment of adults with lateonset Pompe disease (acid α-glucosidase [GAA] deficiency).