TEVA-SUNITINIB CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
24-03-2022
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Active ingredient:
SUNITINIB (SUNITINIB MALATE)
Available from:
TEVA CANADA LIMITED
ATC code:
L01EX01
INN (International Name):
SUNITINIB
Dosage:
25MG
Pharmaceutical form:
CAPSULE
Composition:
SUNITINIB (SUNITINIB MALATE) 25MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0151642002; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-09-11
Summary of Product characteristics
_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
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