NAT-GEFITINIB TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

GEFITINIB

Διαθέσιμο από:

NATCO PHARMA (CANADA) INC

Φαρμακολογική κατηγορία (ATC):

L01EB01

INN (Διεθνής Όνομα):

GEFITINIB

Δοσολογία:

250MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

GEFITINIB 250MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2019-08-23

Αρχείο Π.Χ.Π.

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