AURO-SUNITINIB CAPSULE

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

SUNITINIB (SUNITINIB MALATE)

Предлага се от:

AURO PHARMA INC

АТС код:

L01EX01

INN (Международно Name):

SUNITINIB

дозиране:

37.5MG

Лекарствена форма:

CAPSULE

Композиция:

SUNITINIB (SUNITINIB MALATE) 37.5MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Каталог на резюме:

Active ingredient group (AIG) number: 0151642004; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2022-11-18

Данни за продукта

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