国家: 加拿大
语言: 英文
来源: Health Canada
DEFERASIROX
AURO PHARMA INC
V03AC03
DEFERASIROX
360MG
TABLET
DEFERASIROX 360MG
ORAL
100
Prescription
Active ingredient group (AIG) number: 0151733006; AHFS:
APPROVED
2022-06-02
_Auro-Deferasirox Product Monograph _ Page 1 of 53 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR AURO-DEFERASIROX (TYPE J) Deferasirox Tablets Film-coated Tablets, 90 mg, 180 mg, 360 mg, oral Iron chelating agent Auro Pharma Inc. 3700 Steeles Avenue West, Suite # 402 Woodbridge, Ontario, L4L 8K8, Canada Date of Initial Authorization: June 2, 2022 Date of Revision: March 22, 2023 Submission Control Number: 268479 _Auro-Deferasirox Product Monograph _ Page 2 of 53 RECENT MAJOR LABEL CHANGES 3 Serious Warnings and Precautions Box 03/2023 4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations; 4.2 Recommended Dose and Dosage Adjustment 03/2023 7 WARNINGS AND PRECAUTIONS; Ear/Nose/Throat; Hepatic/Biliary/Pancreatic; Monitoring and Laboratory Tests; Renal 03/2023 7 WARNINGS AND PRECAUTIONS, 7.1 Special Populations, 7.1.3 Pediatrics (2 to 16 years of age) 03/2023 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 ..................................................................................................................... 4 2 CONTRAINDICATIONS ............................................................................................................ 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ....................................................................... 5 4 DOSAGE AND ADMINISTRATIO 阅读完整的文件