WAKIX TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

PITOLISANT HYDROCHLORIDE

Tilgængelig fra:

ENDO VENTURES LTD.

ATC-kode:

N07XX11

INN (International Name):

PITOLISANT

Dosering:

5MG

Lægemiddelform:

TABLET

Sammensætning:

PITOLISANT HYDROCHLORIDE 5MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

Wakefulness-Promoting Agents

Produkt oversigt:

Active ingredient group (AIG) number: 0162928002; AHFS:

Autorisation status:

APPROVED

Autorisation dato:

2021-05-25

Produktets egenskaber

_ _
_WAKIX_
_®_
_ (pitolisant hydrochloride tablets) Product Monograph _
_Page 1 of 35 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
WAKIX
®
Pitolisant hydrochloride tablets
Tablets, 5 mg and 20 mg, Oral
Histamine H3 receptor antagonist / inverse agonist
Endo Ventures Ltd.
First Floor, Minerva House,
Simmonscourt Road, Ballsbridge
Dublin 4, Ireland
Importer/Distributor:
Paladin Labs Inc.
100 Alexis Nihon Blvd, Suite 600
St-Laurent, H4M 2P2
Quebec, Canada
Date of Initial Authorization:
May 25, 2021
Date of Revision:
January 25, 2024
Version 3.0
Submission Control Number: 270856
®
Registered trademark of Bioprojet Europe Ltd.
_ _
_WAKIX_
_®_
_ (pitolisant hydrochloride tablets) Product Monograph _
_Page 2 of 35 _
RECENT MAJOR LABEL CHANGES
1 INDICATIONS, 1.1 Pediatrics
01/2024
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing
Considerations; 4.2 Recommended Dose and Dosage
Adjustment
01/2024
7 WARNINGS AND PRECAUTIONS, 7.1.2 Breastfeeding
05/2023
7 WARNINGS AND PRECAUTIONS, Dependence/Tolerance;
7.1.3 Pediatrics
01/2024
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of most
recent authorization are not
listed.
RECENT MAJOR LABEL CHANGES
.........................................................................................
2
TABLE OF CONTENTS
...............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................. 4
1
INDICATIONS
...................................................................................................................
4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
4
D