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:
2020-07-29
Original market date: See footnote 1
2020-07-29
Product name:
TIBELLA
DIN:
02488361
Product Monograph/Veterinary Labelling:
Date:
2022-05-17
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BIOSYENT PHARMA INC
SUITE 402
2476 Argentia Road
Mississauga
Ontario
Canada
L5N 6M1
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Schedule G (CDSA IV)
American Hospital Formulary Service (AHFS): See footnote 3
68:16.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
G03CX01 TIBOLONE
Active ingredient group (AIG) number:See footnote5
0161430001
Active ingredient(s) | Strength |
---|---|
TIBOLONE | 2.5 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.