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:
Cancelled Pre Market
Current status date:
2023-12-12
Original market date: See footnote 1
Product name:
EMPLICITI
Description:
300 MG AFTER RECONSTITUTION, SINGLE USE VIAL
DIN:
02455927
Product Monograph/Veterinary Labelling:
Date:
2016-08-29
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BRISTOL-MYERS SQUIBB CANADA
2344 Boul. Alfred-Nobel, Suite 300
St-Laurent
Quebec
Canada
H4S 0A4
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
10:00.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
L01FX08 ELOTUZUMAB
Active ingredient group (AIG) number:See footnote5
0158230002
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| ELOTUZUMAB | 340 MG / VIAL |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.