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:

2003-01-16

Original market date: See footnote 1

1998-04-01

Product name:

SEREVENT DISKUS (50MCG/DOSE)

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DIN:

02231129

Product Monograph/Veterinary Labelling:

Date: 2021-03-02 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

GLAXOSMITHKLINE INC
800 100 Milverton Drive
Mississauga
Ontario
Canada L5R 4H1

Class:

Human

Dosage form(s):

Powder

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

R03AC12 SALMETEROL

Active ingredient group (AIG) number:See footnote5

0126960002

List of active ingredient(s)
Active ingredient(s) Strength
SALMETEROL (SALMETEROL XINAFOATE) 50 MCG / ACT

Risk Management Plans See footnote 7

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

Version 4.0.2
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