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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:

2011-08-06

Original market date: See footnote 1

2001-06-18

Product name:

MISOPROSTOL

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:

02244023

Product Monograph/Veterinary Labelling:

Date: 2010-05-28 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

AA PHARMA INC
UNIT 1  1165 Creditstone Road
Vaughan
Ontario
Canada  L4K 4N7

Class: 

Human

Dosage form(s):

Tablet

Route(s) of administration:

Oral

Number of active ingredient(s):

1

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

56:28.28   PROSTAGLANDINS

Anatomical Therapeutic Chemical (ATC): See footnote 4

A02BB01  MISOPROSTOL

Active ingredient group (AIG) number:See footnote 5

0116767001

List of active ingredient(s)
Active ingredient(s) Strength
MISOPROSTOL 200 MCG

Application information

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