AURO-SUNITINIB CAPSULE
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
24-10-2022
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Aktiv bestanddel:
SUNITINIB (SUNITINIB MALATE)
Tilgængelig fra:
AURO PHARMA INC
ATC-kode:
L01EX01
INN (International Name):
SUNITINIB
Dosering:
50MG
Lægemiddelform:
CAPSULE
Sammensætning:
SUNITINIB (SUNITINIB MALATE) 50MG
Indgivelsesvej:
ORAL
Enheder i pakken:
15G/50G
Recept type:
Prescription
Produkt oversigt:
Active ingredient group (AIG) number: 0151642003; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2022-11-18
Produktets egenskaber
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
.................
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