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:
2022-03-24
Original market date: See footnote 1
1998-11-16
Product name:
ESTROGEL
Description:
METERED-DOSE PUMP
DIN:
02238704
Product Monograph/Veterinary Labelling:
Date:
2024-03-06
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
ORGANON CANADA INC.
300
16766 Route Transcanadienne
Kirkland
Quebec
Canada
H9H 4M7
Class:
Human
Dosage form(s):
Gel
Route(s) of administration:
Transdermal
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
68:16.04
Anatomical Therapeutic Chemical (ATC): See footnote 4
G03CA03 ESTRADIOL
Active ingredient group (AIG) number:See footnote5
0106457004
| Active ingredient(s) | Strength |
|---|---|
| ESTRADIOL (ESTRADIOL HEMIHYDRATE) | 0.06 % / W/W |