NAT-GEFITINIB TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

GEFITINIB

Available from:

NATCO PHARMA (CANADA) INC

ATC code:

L01EB01

INN (International Name):

GEFITINIB

Dosage:

250MG

Pharmaceutical form:

TABLET

Composition:

GEFITINIB 250MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

ANTINEOPLASTIC AGENTS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2019-08-23

Summary of Product characteristics

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