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:

Cancelled Post Market

Current status date:

2006-09-12

Original market date: See footnote 1

1995-12-31

Product name:

SALOFALK (R) 5-ASA SUPPOSITORIES - 250MG

Description:

ALSO KNOWN AS MESALAMINE

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DIN:

02112752

Product Monograph/Veterinary Labelling:

Date: 2004-09-10 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company:

AXCAN PHARMA INC
597 Laurier Blvd
Mont St-Hilaire
Quebec
Canada J3H 6C4

Class:

Human

Dosage form(s):

Suppository

Route(s) of administration:

Rectal

Number of active ingredient(s):

1

Schedule(s):

Prescription

 

American Hospital Formulary Service (AHFS): See footnote 3

56:36.00 

Anatomical Therapeutic Chemical (ATC): See footnote 4

A07EC02 MESALAZINE

Active ingredient group (AIG) number:See footnote5

0116808003

List of active ingredient(s)
Active ingredient(s) See footnote8 Strength
MESALAZINE 250 MG
Version 4.0.3

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