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:
2022-08-23
Original market date: See footnote 1
2022-08-23
Product name:
KIMMTRAK
Description:
SINGLE USE
DIN:
02527588
Product Monograph/Veterinary Labelling:
Date:
2022-06-07
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
IMMUNOCORE IRELAND LIMITED
1
Sky Business Centres; Unit 21 Block Port Tunnel; Business Park, Clonshaugh
Dublin
--
Ireland
17
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription, Schedule D
Anatomical Therapeutic Chemical (ATC): See footnote 4
L01F MONOCLONAL ANTIBODIES AND ANTIBODY DRUG CONJUGATES
Active ingredient group (AIG) number:See footnote 5
0163721001
| Active ingredient(s) | Strength |
|---|---|
| TEBENTAFUSP | 100 MCG / 0.5 ML |