NAT-GEFITINIB TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

GEFITINIB

Pieejams no:

NATCO PHARMA (CANADA) INC

ATĶ kods:

L01EB01

SNN (starptautisko nepatentēto nosaukumu):

GEFITINIB

Deva:

250MG

Zāļu forma:

TABLET

Kompozīcija:

GEFITINIB 250MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

15G/50G

Receptes veids:

Prescription

Ārstniecības joma:

ANTINEOPLASTIC AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0149783001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2019-08-23

Produkta apraksts

_Product Monograph NAT-GEFITINIB _
_Page 1 of 41 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
NAT-GEFITINIB
Gefitinib Tablets
Tablets, 250 mg
Epidermal Growth Factor Receptor (EGFR) Tyrosine Kinase Inhibitor
Natco Pharma (Canada) Inc.
2000 Argentia Road, Plaza 1, Suite 200
Mississauga, Ontario
Canada, L5N 1P7
Date of Initial Authorization:
AUG 23, 2019
Date of Revision:
OCT 21, 2021
Submission Control Number: 252645
_ _
_NAT-GEFITINIB Product Monograph _
_Page 2 of 41_
RECENT MAJOR LABEL CHANGES
Not Applicable.
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
................................................................................................................2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................4
1
INDICATIONS
................................................................................................................4
1.1
Pediatrics...........................................................................................................4
1.2
Geriatrics
...........................................................................................................4
2
CONTRAINDICATIONS
...................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..............................................................4
4
DOSAGE AND
ADMINISTRATION...................................................................................5
4.2
Recommended Dose and Dosage Adjustment
.....................................................5
4.4
Administration
...................................................................................................6
4.5
Missed Dose
.....................................................................................