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:
2023-03-15
Original market date: See footnote 1
2023-03-15
Product name:
SUNLENCA
Description:
SINGLE-DOSE VIALS
DIN:
02532476
Product Monograph/Veterinary Labelling:
Date:
2024-10-31
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
GILEAD SCIENCES CANADA INC
400
6925 Century Avenue
Mississauga
Ontario
Canada
L5N 7K2
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Subcutaneous
Number of active ingredient(s):
1
Schedule(s):
Prescription
American Hospital Formulary Service (AHFS): See footnote 3
08:18.08.92
Anatomical Therapeutic Chemical (ATC): See footnote 4
J05AX31 LENACAPAVIR
Active ingredient group (AIG) number:See footnote5
0164221001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| LENACAPAVIR (LENACAPAVIR SODIUM) | 309 MG / ML |