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:
2022-12-02
Original market date: See footnote 1
2012-07-19
Product name:
ALOXI
Description:
SINGLE USE VIAL
DIN:
02381710
Product Monograph/Veterinary Labelling:
Date:
2022-10-24
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
KNIGHT THERAPEUTICS INC.
1055
3400 De Maisonneuve Blvd W
Montreal
Quebec
Canada
H3Z 3B8
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
56:22.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
A04AA05 PALONOSETRON
Active ingredient group (AIG) number:See footnote5
0153130001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| PALONOSETRON (PALONOSETRON HYDROCHLORIDE) | 0.25 MG / 5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.