Product information
From Health Canada
The product monograph is developed by a drug sponsor according to guidelines published by Health Canada that provide direction on the content and format. The veterinary labelling is developed by the drug sponsor according to the Food and Drug Regulations. While Health Canada reviews the product monograph or the veterinary labelling as part of the drug review process, it remains the responsibility of the drug sponsor to ensure that the product monograph or the veterinary labelling is complete and accurate.
Current status:
Marketed
Current status date:
2023-08-03
Original market date: See footnote 1
2018-01-15
Product name:
GALAFOLD
DIN:
02468042
Product Monograph/Veterinary Labelling:
Date:
2024-11-25
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
AMICUS THERAPEUTICS CANADA INC.
100 King Street West, Suite 1600, 1 First Canadian Place
Toronto
Ontario
Canada
M5X 1G5
Class:
Human
Dosage form(s):
Capsule
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
92:92.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
A16AX14 MIGALASTAT
Active ingredient group (AIG) number:See footnote5
0159450001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| MIGALASTAT (MIGALASTAT HYDROCHLORIDE) | 123 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.