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:
2024-09-16
Product name:
SANDOZ TOFACITINIB
DIN:
02551691
Product Monograph/Veterinary Labelling:
Date:
2024-09-16
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
SANDOZ CANADA INCORPORATED
110 Rue De Lauzon
Boucherville
Quebec
Canada
J4B 1E6
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
92:36.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L04AF01 TOFACITINIB
Active ingredient group (AIG) number:See footnote5
0155550001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| TOFACITINIB (TOFACITINIB CITRATE) | 5 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Additional Risk Minimization Measures |
|---|
| Healthcare Professional Education |
| Patient Wallet Card |