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:
2017-01-10
Original market date: See footnote 1
2017-01-10
Product name:
MIFEGYMISO
DIN:
02444038
Product Monograph/Veterinary Labelling:
Date:
2025-02-11
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):
Tablet , Kit
Route(s) of administration:
Buccal , Oral
Number of active ingredient(s):
2
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
76:00.00 , 56:28.28
Anatomical Therapeutic Chemical (ATC): See footnote 4
G03XB51 MIFEPRISTONE, COMBINATIONS
Active ingredient group (AIG) number:See footnote5
0257170001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| MIFEPRISTONE | 200 MG |
| MISOPROSTOL | 200 MCG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Patient Wallet Card |
| Patient Education |
| Healthcare Professional Education |
| Patient Consent |