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
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
| 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.