TEVA-SUNITINIB CAPSULE

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

SUNITINIB (SUNITINIB MALATE)

MAH:

TEVA CANADA LIMITED

ATC_code:

L01EX01

INN:

SUNITINIB

dosage:

12.5MG

pharmaceutical_form:

CAPSULE

composition:

SUNITINIB (SUNITINIB MALATE) 12.5MG

administration_route:

ORAL

units_in_package:

15G/50G

prescription_type:

Prescription

leaflet_short:

Active ingredient group (AIG) number: 0151642001; AHFS:

authorization_status:

APPROVED

authorization_date:

2023-09-11

SPC

_Teva-Sunitinib Capsules _
_Page 1 of 73_
PRODUCT MONOGRAPH
Pr
TEVA-SUNITINIB
Sunitinib Capsules
12.5 mg, 25 mg and 50 mg sunitinib per capsule (as sunitinib malate)
Tyrosine Kinase Inhibitor, Anti-Tumour Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Preparation:
March 24, 2022
Submission Control No: 233932
_Teva-Sunitinib Capsules _
_Page 2 of 73_
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
..................................................................................................32
DOSAGE AND ADMINISTRATION
..............................................................................34
OVERDOSAGE
................................................................................................................35
ACTION AND CLINICAL PHARMACOLOGY
............................................................35
STORAGE AND STABILITY
..........................................................................................39
SPECIAL HANDLING INSTRUCTIONS
.......................................................................39
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................39
PART II: SCIENTIFIC INFORMATION
...............................................................................41
PHARMACEUTICAL INFORMATION
..........................................................................41
CLINICAL TRIALS