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:
2011-08-24
Original market date: See footnote 1
2011-08-24
Product name:
BENLYSTA
Description:
FOR I.V. INFUSION ONLY. 80MG/ML(RECONST.) - 5ML VIAL.
DIN:
02370050
Product Monograph/Veterinary Labelling:
Date:
2024-03-06
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
GLAXOSMITHKLINE INC
800
100 Milverton Drive
Mississauga
Ontario
Canada
L5R 4H1
Class:
Human
Dosage form(s):
Powder For Solution
Route(s) of administration:
Intravenous
Number of active ingredient(s):
1
Schedule(s):
Schedule D , Prescription
American Hospital Formulary Service (AHFS): See footnote 3
92:44.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L04AG04 BELIMUMAB
Active ingredient group (AIG) number:See footnote5
0152941002
| Active ingredient(s) | Strength |
|---|---|
| BELIMUMAB | 120 MG / VIAL |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Observational Studies |
| Registry |