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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:

2020-03-26

Original market date: See footnote 1

2012-12-11

Product name:

ALLERJECT

Description:

PREFILLED AUTO-INJECTOR - SINGLE USE

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:

02382067

Product Monograph/Veterinary Labelling:

Date: 2019-11-21 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

KALEO INC
111 Virginia Street, Suite 300
Richmond
Virginia
United States  23219

Class: 

Human

Dosage form(s):

Solution

Route(s) of administration:

Intramuscular

Number of active ingredient(s):

1

Schedule(s):

Ethical  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

12:12.12   ALPHA-AND BETA-ADRENERGIC AGONISTS

Anatomical Therapeutic Chemical (ATC): See footnote 4

C01CA24  EPINEPHRINE

Active ingredient group (AIG) number:See footnote 5

0104871002

List of active ingredient(s)
Active ingredient(s) Strength
EPINEPHRINE 0.3 MG / 0.3 ML

Application information

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