TARO-DASATINIB TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
19-03-2021
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Active ingredient:
DASATINIB
Available from:
TARO PHARMACEUTICALS INC
ATC code:
L01EA02
INN (International Name):
DASATINIB
Dosage:
50MG
Pharmaceutical form:
TABLET
Composition:
DASATINIB 50MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0152198002; AHFS:
Authorization status:
APPROVED
Authorization date:
2020-05-21
Summary of Product characteristics
Page 1 of 65
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TARO-DASATINIB
Dasatinib Tablets
20 mg, 50 mg, 70 mg, 80 mg, 100 mg and 140 mg dasatinib
Protein-tyrosine kinase inhibitor
TARO PHARMACEUTICALS INC.
130 East Drive,
Brampton, Ontario
Canada L6T 1C1
Date of Revision:
March 19, 2021
Submission Control No: 245318
Page 2 of 65
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
.............................................................................................
14
DRUG INTERACTIONS
.............................................................................................
28
DOSAGE AND ADMINISTRATION
..........................................................................
30
OVERDOSAGE
...........................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 33
STORAGE AND STABILITY
.....................................................................................
35
SPECIAL HANDLING INSTRUCTIONS
................................................................... 35
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 35
PART II: SCIENTIFIC INFORMATION
..........................................................................
37
PHARMACEUTICAL INFORMATION
......................................................................
37
CLINICAL TRIALS
.........................................................................................
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