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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:

2017-01-10

Original market date: See footnote 1

2017-01-10

Product name:

MIFEGYMISO

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:

02444038

Product Monograph/Veterinary Labelling:

Date: 2019-04-15 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

LINEPHARMA INTERNATIONAL LIMITED
16 Upper Woburn Place
London
Greater London
United Kingdom  WC1H0BS

Class: 

Human

Dosage form(s):

Tablet,  Kit

Route(s) of administration:

Oral,  Buccal

Number of active ingredient(s):

2

Schedule(s):

Prescription  

Biosimilar Biologic Drug:

No

American Hospital Formulary Service (AHFS): See footnote 3

56:28.28   PROSTAGLANDINS ,  76:00.00   OXYTOCICS

Anatomical Therapeutic Chemical (ATC): See footnote 4

G03XB51  MIFEPRISTONE, COMBINATIONS

Active ingredient group (AIG) number:See footnote 5

0257170001

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

Risk Management Plans See footnote 7

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

Additional Risk Minimization Measures
Healthcare Professional Education
Patient Education
Patient Consent
Patient Wallet Card

Application information

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