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:

Cancelled Post Market

Current status date:

2023-06-30

Original market date: See footnote 1

2021-11-23

Lot number: See footnote 2

1875739

Expiry date: See footnote 2

2023-09-30

Product name:

JCOVDEN

Description:

VIAL CONTAINS 5 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:

02513153

Product Monograph/Veterinary Labelling:

Date: 2023-02-16 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

JANSSEN INC
19 Green Belt Drive
Toronto
Ontario
Canada M3C 1L9

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

J07BN02 COVID-19, VIRAL VECTOR, NON-REPLICATING

Active ingredient group (AIG) number:See footnote5

0162788001

List of active ingredient(s)
Active ingredient(s) Strength
AD26.COV2.S [RECOMBINANT] 50000000000 VP / 0.5 ML

Risk Management Plans See footnote 7

A Risk Management Plan (RMP) for this product was submitted.

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