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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:

2020-10-20

Original market date: See footnote 1

2020-10-20

Product name:

LUNESTA

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:

02453223

Product Monograph/Veterinary Labelling:

Date: 2020-04-09 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

SUNOVION PHARMACEUTICALS CANADA INC
7025 Langer Drive, Suite 301
Mississauga
Ontario
Canada  L5N 0E8

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

28:24.92   MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Anatomical Therapeutic Chemical (ATC): See footnote 4

N05CF04  ESZOPICLONE

Active ingredient group (AIG) number:See footnote 5

0157971003

List of active ingredient(s)
Active ingredient(s) Strength
ESZOPICLONE 3 MG

Risk Management Plans See footnote 7

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

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