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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

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section .

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  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

80:12.00   VACCINES

Anatomical Therapeutic Chemical (ATC): See footnote 4

J07BA02  ENCEPHALITIS, JAPANESE, INACTIVATED, WHOLE VIRUS

Active ingredient group (AIG) number:See footnote 5

0152652001

List of active ingredient(s)
Active ingredient(s) Strength
INACT.JAPANESE ENCEPHAL VIRUS(ATTENUAT. STRAIN SA14-14-2 PRODUCED IN VERO CELLS) 6 MCG / 0.5 ML

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