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:
Approved
Current status date:
2022-12-16
Product name:
MIFISO
DIN:
02533553
Product Monograph/Veterinary Labelling:
Date:
2022-12-16
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
LINEPHARMA INTERNATIONAL LIMITED
16 Upper Woburn Place
London
Greater London
United Kingdom
WC1H0BS
Class:
Human
Dosage form(s):
Kit , Tablet
Route(s) of administration:
Buccal , Oral
Number of active ingredient(s):
2
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
56:28.28 , 76:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
G03XB51 MIFEPRISTONE, COMBINATIONS
Active ingredient group (AIG) number:See footnote5
0257170002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| MIFEPRISTONE | 200 MG |
| MISOPROSTOL | 200 MCG |