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:
2022-07-11
Product name:
IRINOTECAN HYDROCHLORIDE INJECTION
DIN:
02528797
Product Monograph/Veterinary Labelling:
Date:
2022-07-06
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
EUGIA PHARMA INC.
3700 Steeles Avenue West, Suite 402
Woodbridge
Ontario
Canada
L4L 8K8
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
L01CE02 IRINOTECAN
Active ingredient group (AIG) number:See footnote5
0132910001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| IRINOTECAN HYDROCHLORIDE | 300 MG / 15 ML |