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GALAFOLD (Amicus Therapeutics Pty Ltd)

Product name
Date registered
Evaluation commenced
Decision date
Approval time
196 (255 working days)
Active ingredients
migalastat hydrochloride
Registration type

GALAFOLD is now also indicated for long-term treatment of adult and adolescent patients 12 years and older with a confirmed diagnosis of Fabry disease (?-galactosidase A deficiency) and who have an amenable mutation (see the table in Section 5.1 Pharmacodynamic properties, Mechanism of action)

Registration process

Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.

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