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:

Dormant

Current status date:

2023-03-24

Original market date: See footnote 1

2020-12-14

Product name:

COMIRNATY

Description:

PURPLE CAP VIAL (12+ YEARS) AFTER DILUTION CONTAINS 6 DOSES OF 0.3 ML

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:

02509210

Product Monograph/Veterinary Labelling:

Date: 2023-03-21 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

BIONTECH MANUFACTURING GMBH
An Der Goldgrube 12
Mainz
Rheinland-Pfalz
Germany 55131

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

J07BN01 COVID-19, RNA-BASED VACCINE

Active ingredient group (AIG) number:See footnote5

0162621002

List of active ingredient(s)
Active ingredient(s) Strength
TOZINAMERAN 30 MCG / 0.3 ML

Risk Management Plans See footnote 7

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

Pharmacovigilance/Monitoring Activity
Clinical Trials
Observational Studies
Version 4.0.2
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