Country: Կանադա
language: անգլերեն
source: Health Canada
SUNITINIB (SUNITINIB MALATE)
AURO PHARMA INC
L01EX01
SUNITINIB
50MG
CAPSULE
SUNITINIB (SUNITINIB MALATE) 50MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0151642003; AHFS:
APPROVED
2022-11-18
Page 1 of 66 PRODUCT MONOGRAPH PR AURO-SUNITINIB Sunitinib Capsules 12.5 mg, 25 mg, 37.5 mg, 50 mg Sunitinib (as sunitinib malate) Tyrosine Kinase Inhibitor, Anti-Tumour Agent AURO PHARMA INC. DATE OF PREPARATION: 3700 Steeles Avenue West, Suite # 402 October 24, 2022 Woodbridge, Ontario, L4L 8K8, Canada. Submission Control No: 249322 Page 2 of 66 TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................. 3 SUMMARY PRODUCT INFORMATION..................................................................3 INDICATIONS AND CLINICAL USE .......................................................................3 CONTRAINDICATIONS ...........................................................................................4 WARNINGS AND PRECAUTIONS ...........................................................................4 ADVERSE REACTIONS ......................................................................................... 17 DRUG INTERACTIONS ......................................................................................... 30 DOSAGE AND ADMINISTRATION ...................................................................... 31 OVERDOSAGE ...................................................................................................... 32 ACTION AND CLINICAL PHARMACOLOGY ...................................................... 32 STORAGE AND STABILITY ................................................................................. 36 SPECIAL HANDLING INSTRUCTIONS ................................................................ 36 DOSAGE FORMS, COMPOSITION AND PACKAGING ........................................ 37 PART II: SCIENTIFIC INFORMATION ...................................................................... 38 PHARMACEUTICAL INFORMATION .................................................................. 38 CLINICAL TRIALS ................................................................................................ 39 DETAILED PHARMACOLOGY ................. read_full_document