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:
2022-09-15
Product name:
METHOFILL SELF-DOSE INJECTOR
Description:
SINGLE-DOSE PRE-FILLED AUTO-INJECTOR
DIN:
02530775
Product Monograph/Veterinary Labelling:
Date:
2022-09-14
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ACCORD HEALTHCARE INC
3535 Boulevard St-Charles, Suite 704
Kirkland
Quebec
Canada
H9H 5B9
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
10:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L04AX03 METHOTREXATE
Active ingredient group (AIG) number:See footnote5
0107545005
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| METHOTREXATE (METHOTREXATE SODIUM) | 10 MG / 0.2 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Patient Wallet Card |