Approvals/TGA/GALAFOLD migalastat (as hydrochloride) 123 mg hard capsule blister pack

Approved

STANDARD

GALAFOLD migalastat (as hydrochloride) 123 mg hard capsule blister pack

Amicus Therapeutics Pty Ltd🇦🇺 Therapeutic Goods Administration

Approval Id: 0f19e92c9b2cbc75
Product Name: GALAFOLD migalastat (as hydrochloride) 123 mg hard capsule blister pack
Artg Id: 276051
Artg Name: GALAFOLD migalastat (as hydrochloride) 123 mg hard capsule blister pack
Sponsor: Amicus Therapeutics Pty Ltd
Company Detail Path: /organization/amicus-therapeutics-pty-ltd
Artg Date: 2017-08-11
Registration Type: Medicine
Therapeutic Good Type: Medicine
Licence Status: A
Licence Category: RE
Consumer Medicine Info: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2020-CMI-01589-1
Product Information: http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2018-PI-02361-1

Approved

Agency

TGA

Country

🇦🇺

Approval Date

Dec 9, 2025

Approval ID

0f19e92c9b2cbc75

Type

Standard