TGA Approval

GALAFOLD migalastat (as hydrochloride) 123 mg hard capsule blister pack (276051)

ARTG ID

276051

ARTG Name

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

Sponsor

Amicus Therapeutics Pty Ltd

ARTG Date

August 11, 2017

Registration Type

Medicine

Therapeutic Good Type

Medicine

Licence Status

Active

Licence Category

Registered

Sponsor Information

Sponsor Name

Sponsor Item Name

AMICUS THERAPEUTICS PTY LTD

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2020-CMI-01589-1

http://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent=&id=CP-2018-PI-02361-1

Ingredient Name

migalastat hydrochloride

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GALAFOLD migalastat (as hydrochloride) 123 mg hard capsule blister pack (276051) - TGA 批准文号 | MedPath