TEVA-DASATINIB TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

DASATINIB (DASATINIB MONOHYDRATE)

Available from:

TEVA CANADA LIMITED

ATC code:

L01EA02

INN (International Name):

DASATINIB

Dosage:

50MG

Pharmaceutical form:

TABLET

Composition:

DASATINIB (DASATINIB MONOHYDRATE) 50MG

Administration route:

ORAL

Units in package:

60

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0152198002; AHFS:

Authorization status:

APPROVED

Authorization date:

2020-04-14

Summary of Product characteristics

_TEVA-DASATINIB (dasatinib) _
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_Page 1 of 77 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-DASATINIB
Dasatinib Tablets
Tablets, 20 mg, 50 mg, 70 mg, 80 mg and 100 mg dasatinib (as dasatinib
monohydrate), Oral
Protein Kinase Inhibitor
Teva Canada Limited
Date of Initial Authorization
30 Novopharm Court
April 14, 2020
Toronto, Ontario
M1B 2K9
Date of Revision:
March 29, 2023
Submission Control Number: 266668
_TEVA-DASATINIB (dasatinib) _
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_Page 2 of 77 _
RECENT MAJOR LABEL CHANGES
4 Dosage and Administration, 4.1 Dosing Considerations
04/2021
4 Dosage and Administration, 4.2 Recommended Dose and Dose Adjustment
04/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1 INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2 CONTRAINDICATIONS
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5
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4 DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
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5
4.2 Recommende