GALAFOLD migalastat (as hydrochloride) 123 mg hard capsule blister pack, Amicus Therapeutics Pty Ltd, CON-552
Product name
GALAFOLD migalastat (as hydrochloride) 123 mg hard capsule blister pack
Sponsor name
Amicus Therapeutics Pty Ltd
Consent start
Consent no.
CON-552
Standard
Therapeutic Goods Order No. 91 - Standard for labels of prescription and related medicines
Non-compliance with standard
The product does not conform with the requirements of paragraphs 7(2)(d) and
8(1)(n) of Therapeutic Goods Order 91 in that the text height does not meet
minimum size requirements and the labels do not contain a machine readable code.
Therapeutic product type
Prescription medicines