TAGRISSO TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

OSIMERTINIB (OSIMERTINIB MESYLATE)

Dostupné z:

ASTRAZENECA CANADA INC

ATC kód:

L01EB04

INN (Medzinárodný Name):

OSIMERTINIB

Dávkovanie:

80MG

Forma lieku:

TABLET

Zloženie:

OSIMERTINIB (OSIMERTINIB MESYLATE) 80MG

Spôsob podávania:

ORAL

Počet v balení:

30

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTINEOPLASTIC AGENTS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2016-07-05

Súhrn charakteristických

_ _
_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
.........................................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
..........................................................................................................................
4
1.1
Pediatrics
...........................................................................................................................4
1.2
Geriatrics
............................................................................................................................4
2
CONTRAINDICATIONS
..........................................