AURO-SUNITINIB CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

SUNITINIB (SUNITINIB MALATE)

Saatavilla:

AURO PHARMA INC

ATC-koodi:

L01EX01

INN (Kansainvälinen yleisnimi):

SUNITINIB

Annos:

50MG

Lääkemuoto:

CAPSULE

Koostumus:

SUNITINIB (SUNITINIB MALATE) 50MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0151642003; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2022-11-18

Valmisteyhteenveto

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
.................