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:

Marketed

Current status date:

2019-12-16

Original market date: See footnote 1

2002-08-22

Product name:

APO-SALBUTAMOL HFA

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DIN:

02245669

Product Monograph/Veterinary Labelling:

Date: 2021-06-25 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

APOTEX INC
150 Signet Drive
Toronto
Ontario
Canada M9L 1T9

Class:

Human

Dosage form(s):

Metered-Dose Aerosol

Route(s) of administration:

Inhalation

Number of active ingredient(s):

1

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

12:12.08.12 

Anatomical Therapeutic Chemical (ATC): See footnote 4

R03AC02 SALBUTAMOL

Active ingredient group (AIG) number:See footnote5

0108887003

List of active ingredient(s)
Active ingredient(s) Strength
SALBUTAMOL (SALBUTAMOL SULFATE) 100 MCG / ACT
Version 4.0.2
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