TEVA-SUNITINIB CAPSULE

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

SUNITINIB (SUNITINIB MALATE)

Mevcut itibaren:

TEVA CANADA LIMITED

ATC kodu:

L01EX01

INN (International Adı):

SUNITINIB

Doz:

12.5MG

Farmasötik formu:

CAPSULE

Kompozisyon:

SUNITINIB (SUNITINIB MALATE) 12.5MG

Uygulama yolu:

ORAL

Paketteki üniteler:

15G/50G

Reçete türü:

Prescription

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2023-09-11

Ürün özellikleri

_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