Product information
From Health Canada
No match found
No other product was found with the same active ingredient group.
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:
2020-03-10
Original market date: See footnote 1
2020-03-10
Product name:
ROZLYTREK
DIN:
02495007
Product Monograph/Veterinary Labelling:
Date:
2023-11-09
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
HOFFMANN-LA ROCHE LIMITED
7070 Mississauga Road
Mississauga
Ontario
Canada
L5N 5M8
Class:
Human
Dosage form(s):
Capsule
Route(s) of administration:
Oral
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
10:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L01EX14 ENTRECTINIB
Active ingredient group (AIG) number:See footnote5
0162010001
Active ingredient(s) See footnote8 | Strength |
---|---|
ENTRECTINIB | 100 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.