NAT-GEFITINIB TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

GEFITINIB

Boleh didapati daripada:

NATCO PHARMA (CANADA) INC

Kod ATC:

L01EB01

INN (Nama Antarabangsa):

GEFITINIB

Dos:

250MG

Borang farmaseutikal:

TABLET

Komposisi:

GEFITINIB 250MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

15G/50G

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2019-08-23

Ciri produk

_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
.....................................................................................