Land: Canada
Taal: Engels
Bron: Health Canada
PAZOPANIB (PAZOPANIB HYDROCHLORIDE)
PHARMASCIENCE INC
L01EX03
PAZOPANIB
200MG
TABLET
PAZOPANIB (PAZOPANIB HYDROCHLORIDE) 200MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0152743001; AHFS:
APPROVED
2022-03-03
PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR PMS-PAZOPANIB Pazopanib tablets Tablets, 200 mg pazopanib (as pazopanib hydrochloride), oral Antineoplastic Agent ATC Code: L01XE11 Pharmascience Inc. Date of Initial Authorization: 6111 Royalmount Ave., suite 100 March 1, 2022 Montréal, Canada H4P 2T4 www.pharmascience.com Submission Control Number: 254544 _pms-PAZOPANIB – Product Monograph _ _ _ _Page 2 of 54_ RECENT MAJOR LABEL CHANGES Not Applicable TABLE OF CONTENTS SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF 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 ......................................................................................................... 5 2 CONTRAINDICATIONS................................................................................................ 5 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ........................................................... 5 4 DOSAGE AND ADMINISTRATION ............................................................................... 6 4.1 Dosing Considerations ...................................................................................... 6 4.2 Recommended Dose and Dosage Adjustment ................................................... 6 4.4 Administration ................................................................................................. 6 4.5 Missed Dose ......................................................... Lees het volledige document