IMATINIB TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-10-2021
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Active ingredient:
IMATINIB (IMATINIB MESYLATE)
Available from:
SIVEM PHARMACEUTICALS ULC
ATC code:
L01EA01
INN (International Name):
IMATINIB
Dosage:
100MG
Pharmaceutical form:
TABLET
Composition:
IMATINIB (IMATINIB MESYLATE) 100MG
Administration route:
ORAL
Units in package:
100
Prescription type:
Prescription
Therapeutic area:
ANTINEOPLASTIC AGENTS
Product summary:
Active ingredient group (AIG) number: 0145503002; AHFS:
Authorization status:
APPROVED
Authorization date:
2021-10-13
Summary of Product characteristics
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
IMATINIB
Imatinib Mesylate Tablets
Imatinib 100 mg and 400 mg Tablets
Protein kinase inhibitor
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
Date of Preparation:
October 12, 2021
Submission
Control No: 248884
_ IMATINIB Product Monograph _
_Page 2 of 77_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................... 3
SUMMARY PRODUCT INFORMATION
.............................................................. 3
INDICATIONS AND CLINICAL USE
.................................................................... 3
CONTRAINDICATIONS.........................................................................................
5
WARNINGS AND PRECAUTIONS
........................................................................
5
ADVERSE REACTIONS
.......................................................................................
13
DRUG INTERACTIONS
.......................................................................................
25
DOSAGE AND ADMINISTRATION
....................................................................
27
OVERDOSAGE......................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
.................................................. 32
STORAGE AND
STABILITY................................................................................
37
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................... 37
PART II: SCIENTIFIC
INFORMATION.........................................................................
39
PHARMACEUTICAL INFORMATION
............................................................... 39
CLINICAL
TRIALS...............................................................................................
40
COMPARATIVE BIOAVAILABILITY STUDY
.................................................. 40
TOXICOLOGY
................................................
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