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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:

Approved

Current status date:

2021-05-25

Product name:

WAKIX

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:

02516241

Product Monograph/Veterinary Labelling:

Date: 2021-08-09 Product monograph/Veterinary Labelling (PDF version ~ 175K)

Company: 

ENDO VENTURES LTD.
1st Floor, Minerva House, Simmonscourt Road
Ballsbridge
Dublin
Ireland  D04 H9P8

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

28:20.80   Wakefulness-Promoting Agents

Anatomical Therapeutic Chemical (ATC): See footnote 4

N07XX11  PITOLISANT

Active ingredient group (AIG) number:See footnote 5

0162928002

List of active ingredient(s)
Active ingredient(s) Strength
PITOLISANT HYDROCHLORIDE 5 MG

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