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:
2023-09-08
Original market date: See footnote 1
2023-09-08
Product name:
WINLEVI
DIN:
02538881
Product Monograph/Veterinary Labelling:
Date:
2023-06-15
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
SUN PHARMACEUTICAL INDUSTRIES LIMITED
Sun House, Plot 201 B/1, Western Express Highway, Goregaon (E)
Mumbai
Maharashtra
India
400063
Class:
Human
Dosage form(s):
Cream
Route(s) of administration:
Topical
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
84:06.92
Anatomical Therapeutic Chemical (ATC): See footnote 4
D10AX06 CLASCOTERONE
Active ingredient group (AIG) number:See footnote5
0164781001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| CLASCOTERONE | 1 % / W/W |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.