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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:

2020-12-23

Original market date: See footnote 1

2020-12-23

Product name:

COVID-19 VACCINE MODERNA

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:

02510014

Product Monograph/Veterinary Labelling:

Date: 2021-06-09 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

MODERNATX, INC.
200 Technology Square
Cambridge
Massachusetts
United States  02139

Class: 

Human

Dosage form(s):

Dispersion

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

0162662001

List of active ingredient(s)
Active ingredient(s) Strength
MRNA-1273 SARS-COV-2 100 MCG / 0.5 ML

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