Land: Kanada
Sprache: Englisch
Quelle: Health Canada
PITOLISANT HYDROCHLORIDE
ENDO VENTURES LTD.
N07XX11
PITOLISANT
20MG
TABLET
PITOLISANT HYDROCHLORIDE 20MG
ORAL
15G/50G
Prescription
Wakefulness-Promoting Agents
Active ingredient group (AIG) number: 0162928001; AHFS:
APPROVED
2021-05-25
_ _ _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 Lesen Sie das vollständige Dokument