LENVIMA CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

LENVATINIB (LENVATINIB MESYLATE)

Διαθέσιμο από:

EISAI LIMITED

Φαρμακολογική κατηγορία (ATC):

L01EX08

INN (Διεθνής Όνομα):

LENVATINIB

Δοσολογία:

20MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

LENVATINIB (LENVATINIB MESYLATE) 20MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

60

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANTINEOPLASTIC AGENTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0157671002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2015-12-22

Αρχείο Π.Χ.Π.

_Product Monograph _
_Template Date: September 2020 _
_LENVIMA_
_®_
_ lenvatinib capsules _
_Page 1 of 110_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
LENVIMA®
Lenvatinib capsules
4 mg and 10 mg Lenvatinib (as lenvatinib mesylate)
Multiple Receptor Tyrosine Kinase Inhibitor
Antineoplastic Agent, ATC code: L01EX08
Eisai Limited
6925 Century Avenue, Suite 701
Mississauga, Ontario
L5N 7K2
Date of Initial Authorization:
DEC 22, 2015
Date of Revision:
JUL 19, 2023
Submission Control Number: 267356
_LENVIMA_
_®_
_ lenvatinib capsules _
_Page 2 of 110_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
[07/2023]
1 INDICATIONS, 1.2 Geriatrics
[07/2023]
4 DOSAGE AND ADMINISTRATION, 4.2 Recommended Dose and
Dosage Adjustment
[05/2022]
7 WARNINGS AND PRECAUTIONS
[07/2023]
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 (<18 years of age)
....................................................................................
4
1.2
Geriatrics (≥ 65 years of age)
...................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 5
4
DOSAGE AND ADMINISTRATION
................................................................................
6
4.1
Dosing Considerations
.................................................................