TAGRISSO TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

OSIMERTINIB (OSIMERTINIB MESYLATE)

Available from:

ASTRAZENECA CANADA INC

ATC code:

L01EB04

INN (International Name):

OSIMERTINIB

Dosage:

80MG

Pharmaceutical form:

TABLET

Composition:

OSIMERTINIB (OSIMERTINIB MESYLATE) 80MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

Active ingredient group (AIG) number: 0158250002; AHFS:

Authorization status:

APPROVED

Authorization date:

2016-07-05

Summary of Product characteristics

_ _
_TAGRISSO_
_®_
_ (osimertinib) Product Monograph. _
_Page 1 of 62_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
TAGRISSO®
osimertinib tablets
Tablets, 40 mg and 80 mg osimertinib (as osimertinib mesylate), Oral
Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor,
L01XE35
AstraZeneca Canada Inc.
1004 Middlegate Road, Suite 5000
Mississauga, Ontario
Canada, L4Y 1M4
www.astrazeneca.ca
Date of Initial Authorization:
JUL 05, 2016
Date of Revision:
JAN 02, 2024
Submission Control Number: 277035
TAGRISSO® is a registered trademark of AstraZeneca AB, used under
license by AstraZeneca Canada Inc.
©AstraZeneca Canada Inc. 2023
_ _
_TAGRISSO_
_®_
_ (osimertinib) Product Monograph. _
_Page 2 of 62_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
01/2021
1 INDICATIONS, 1.2 Geriatrics
01/2021
4 DOSAGE AND ADMINISTRATION, 4.1 Dosing Considerations
01/2021
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
03/2023
7 WARNINGS AND PRECAUTIONS
01/2024
7 WARNINGS AND PRECAUTIONS, 7.1.4 Geriatrics
01/2021
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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1.2
Geriatrics
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2
CONTRAINDICATIONS
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