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:
Approved
Current status date:
2022-11-09
Product name:
ERVEBO
Description:
SINGLE DOSE VIAL
DIN:
02532603
Product Monograph/Veterinary Labelling:
Date:
2022-11-09
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
MERCK CANADA INC
16750 Route Transcanadienne
Kirkland
Quebec
Canada
H9H 4M7
Class:
Human
Dosage form(s):
Solution
Route(s) of administration:
Intramuscular
Number of active ingredient(s):
1
Schedule(s):
Schedule D
American Hospital Formulary Service (AHFS): See footnote 3
80:12.00
Anatomical Therapeutic Chemical (ATC): See footnote 4
J07BX02 EBOLA VACCINES
Active ingredient group (AIG) number:See footnote5
0164261001
| Active ingredient(s) | Strength |
|---|---|
| EBOLA ZAÏRE VACCINE (rVSV [DELTA] G-ZEBOV-GP, LIVE) | 72000000 PFU / ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Clinical Trials |
| Observational Studies |