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:
Restricted Access
Current status date:
2023-05-29
Original market date: See footnote 1
2015-06-15
Product name:
IMVAMUNE
Description:
MODIFIED VACCINIA VIRUS, LIVE, ATTENUATED, NON REPLICATING. 20X0.5ML SINGLE-DOSE VIALS
DIN:
02416638
Product Monograph/Veterinary Labelling:
Date:
2023-08-03
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
BAVARIAN NORDIC AS
Philip Heymans Alle 3
Hellerup
--
Denmark
2900
Class:
Human
Dosage form(s):
Suspension
Route(s) of administration:
Subcutaneous
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
J07BX01 SMALLPOX AND MONKEYPOX VACCINES
Active ingredient group (AIG) number:See footnote5
0155011001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| MODIFIED VACCINIA VIRUS (ANKARA-BAVARIAN NORDIC) | 50000000 CCID50 / 0.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.
| Pharmacovigilance/Monitoring Activity |
|---|
| Observational Studies |