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:
2013-10-09
Original market date: See footnote 1
2009-12-29
Product name:
IXIARO
DIN:
02333279
Product Monograph/Veterinary Labelling:
Date:
2018-03-02
Product monograph/Veterinary Labelling (PDF version ~ 175K)
Company:
VALNEVA AUSTRIA GMBH
Campus Vienna Biocenter 3
Vienna
Wien
Austria
1030
Class:
Human
Dosage form(s):
Suspension
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
J07BA02 ENCEPHALITIS, JAPANESE, INACTIVATED, WHOLE VIRUS
Active ingredient group (AIG) number:See footnote5
0152652001
| Active ingredient(s) See footnote8 | Strength |
|---|---|
| INACT.JAPANESE ENCEPHAL VIRUS(ATTENUAT. STRAIN SA14-14-2 PRODUCED IN VERO CELLS) | 6 MCG / 0.5 ML |
Risk Management Plans See footnote 7
A Risk Management Plan (RMP) for this product was submitted.