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:
Authorization By Interim Order Revoked
Current status date:
2024-04-29
Original market date: See footnote 1
2021-10-08
Product name:
SOTROVIMAB FOR INJECTION
Description:
SINGLE-USE VIALS
DIN:
02518341
Product Monograph/Veterinary Labelling:
Date:
2023-01-27
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
GLAXOSMITHKLINE INC
800
100 Milverton Drive
Mississauga
Ontario
Canada
L5R 4H1
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Prescription , COVID-19 - IO - Authorization , Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
08:18.24
Anatomical Therapeutic Chemical (ATC): See footnote 4
J06BD05 SOTROVIMAB
Active ingredient group (AIG) number:See footnote5
0163072001
| Active ingredient(s) | Strength |
|---|---|
| SOTROVIMAB | 500 MG / 8 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Observational Studies |
| Clinical Trials |