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:
2018-10-26
Product name:
FOLOTYN
DIN:
02481855
Product Monograph/Veterinary Labelling:
Date:
2018-10-19
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
SERVIER CANADA INC
270
3224 Avenue Jean-Béraud
Laval
Quebec
Canada
H7T 2S4
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
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
L01BA05 PRALATREXATE%
Active ingredient group (AIG) number:See footnote5
0160770001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| PRALATREXATE | 40 MG / 2 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.