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:
2018-06-28
Original market date: See footnote 1
2018-06-28
Product name:
SYMDEKO
Description:
YELLOW TABLET (TEZACAFTOR / IVACAFTOR) AND BLUE TABLET (IVACAFTOR)
DIN:
02478080
Product Monograph/Veterinary Labelling:
Date:
2020-08-21
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
VERTEX PHARMACEUTICALS (CANADA) INCORPORATED
1520
20 Bay Street
Toronto
Ontario
Canada
M5J 2N8
Class:
Human
Dosage form(s):
Tablet
Route(s) of administration:
Oral
Number of active ingredient(s):
3
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
48:14.04 , 48:14.12
Anatomical Therapeutic Chemical (ATC): See footnote 4
R07AX31 IVACAFTOR AND TEZACAFTOR
Active ingredient group (AIG) number:See footnote5
0360330001
| Active ingredient(s) | Strength |
|---|---|
| IVACAFTOR | 150 MG |
| IVACAFTOR | 150 MG |
| TEZACAFTOR | 100 MG |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.