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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:

2021-03-03

Original market date: See footnote 1

2021-03-03

Product name:

COVISHIELD

Description:

VIAL CONTAINS 10 DOSES OF 0.5ML

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:

02512947

Product Monograph/Veterinary Labelling:

Date: 2021-04-23 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

VERITY PHARMACEUTICALS INC.
2560 Matheson Blvd. E., Suite 220
Mississauga
Ontario
Canada  L4W 4Y9

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Intramuscular

Number of active ingredient(s):

1

Schedule(s):

COVID-19 - IO - Authorization,  Schedule D  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

 

Anatomical Therapeutic Chemical (ATC): See footnote 4

J07BX  OTHER VIRAL VACCINES

Active ingredient group (AIG) number:See footnote 5

0162722001

List of active ingredient(s)
Active ingredient(s) Strength
CHADOX1-S [RECOMBINANT] 50000000000 VP / 0.5 ML

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