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:
2020-08-27
Original market date: See footnote 1
2020-08-27
Product name:
TUKYSA
DIN:
02499835
Product Monograph/Veterinary Labelling:
Date:
2020-06-03
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
SEATTLE GENETICS, INC.
21823 30th Drive S.E.
Bothell
Washington
United States
98021
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
Biosimilar Biologic Drug:
No
American Hospital Formulary Service (AHFS): See footnote 3
10:00.00 ANTINEOPLASTIC AGENTS
Anatomical Therapeutic Chemical (ATC): See footnote 4
L01 ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number:See footnote 5
0162296002
| Active ingredient(s) | Strength |
|---|---|
| TUCATINIB | 150 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.