Land: Kanada
Sprache: Englisch
Quelle: Health Canada
SUNITINIB (SUNITINIB MALATE)
NATCO PHARMA (CANADA) INC
L01EX01
SUNITINIB
50MG
CAPSULE
SUNITINIB (SUNITINIB MALATE) 50MG
ORAL
100
Prescription
Active ingredient group (AIG) number: 0151642003; AHFS:
APPROVED
2023-06-30
PRODUCT MONOGRAPH PR NAT-SUNITINIB Sunitinib capsules Capsules, 50 mg sunitinib (as sunitinib malate), Oral Tyrosine Kinase Inhibitor, Anti-Tumour Agent Natco Pharma (Canada) Inc. 2000 Argentia Road, Plaza 1, Suite 200 Mississauga, Ontario L5N 1P7 Date of Initial Authorization: June 29, 2023 Submission Control No.: 254828 _NAT-SUNITINIB Product Monograph _ _Page 2 of 69 _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ........................................................................ 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 4 WARNINGS AND PRECAUTIONS ................................................................................. 5 ADVERSE REACTIONS ................................................................................................. 17 DRUG INTERACTIONS ................................................................................................. 32 DOSAGE AND ADMINISTRATION ............................................................................. 33 OVERDOSAGE ................................................................................................................ 34 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 34 STORAGE AND STABILITY ......................................................................................... 38 SPECIAL HANDLING INSTRUCTIONS ....................................................................... 38 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 39 PART II: SCIENTIFIC INFORMATION............................................................................... 40 PHARMACEUTICAL INFORMATION ......................................................................... 40 CLINICAL TRIALS ... Lesen Sie das vollständige Dokument