The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
Amicus Therapeutics Pty Ltd
Regulatory activities for this sponsor.
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8 result(s) found, displaying 1 to 8
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for POMBILITI cipaglucosidase alfa 105mg powder for injection vial.
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Prescription medicine registrationActive ingredients: cipaglucosidase alfa.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for OPFOLDA miglustat 65 mg capsule bottle.
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Prescription medicine registrationActive ingredients: miglustat.
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Prescription medicine registrationActive ingredients: migalastat hydrochloride.
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ARTGAustralian Register of Therapeutic Goods (ARTG) information for GALAFOLD migalastat (as hydrochloride) 123 mg hard capsule blister pack.
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Australian Public Assessment Report (AusPAR)Australian Public Assessment Report for Migalastat