NAT-GEFITINIB TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

GEFITINIB

متاح من:

NATCO PHARMA (CANADA) INC

ATC رمز:

L01EB01

INN (الاسم الدولي):

GEFITINIB

جرعة:

250MG

الشكل الصيدلاني:

TABLET

تركيب:

GEFITINIB 250MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

15G/50G

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ANTINEOPLASTIC AGENTS

ملخص المنتج:

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

الوضع إذن:

APPROVED

تاريخ الترخيص:

2019-08-23

خصائص المنتج

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