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:
2024-01-30
Original market date: See footnote 1
2024-01-30
Product name:
TESTOSTERONE ENANTHATE INJECTION, USP
DIN:
02536315
Product Monograph/Veterinary Labelling:
Date:
2023-03-17
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
HIKMA CANADA LIMITED
5995 Avebury Road, Suite 804
Mississauga
Ontario
Canada
L5R 3P9
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intramuscular
Number of active ingredient(s):
1
Schedule(s):
Schedule G (CDSA IV)
American Hospital Formulary Service (AHFS): See footnote 3
68:08.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
G03BA03 TESTOSTERONE
Active ingredient group (AIG) number:See footnote5
0106403001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| TESTOSTERONE ENANTHATE | 200 MG / ML |