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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:

2007-11-22

Original market date: See footnote 1

2001-02-22

Product name:

MIRENA

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:

02243005

Product Monograph/Veterinary Labelling:

Date: 2021-09-21 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

BAYER INC
2920 Matheson Blvd East
Mississauga
Ontario
Canada  L4W 5R6

Class: 

Human

Dosage form(s):

Insert (Extended-Release)

Route(s) of administration:

Intrauterine

Number of active ingredient(s):

1

Schedule(s):

Prescription  

American Hospital Formulary Service (AHFS): See footnote 3

68:12.00   CONTRACEPTIVES

Anatomical Therapeutic Chemical (ATC): See footnote 4

G02BA03  PLASTIC IUD WITH PROGESTOGENS

Active ingredient group (AIG) number:See footnote 5

0125218003

List of active ingredient(s)
Active ingredient(s) Strength
LEVONORGESTREL 52 MG

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