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:

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:

02453207

Product Monograph/Veterinary Labelling:

Date: 2022-10-06 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

 

American Hospital Formulary Service (AHFS): See footnote 3

28:24.92 

Anatomical Therapeutic Chemical (ATC): See footnote 4

N05CF04 ESZOPICLONE

Active ingredient group (AIG) number:See footnote5

0157971001

List of active ingredient(s)
Active ingredient(s) Strength
ESZOPICLONE 1 MG

Risk Management Plans See footnote 7

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

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