LENVIMA CAPSULE

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

LENVATINIB (LENVATINIB MESYLATE)

Dostopno od:

EISAI LIMITED

Koda artikla:

L01EX08

INN (mednarodno ime):

LENVATINIB

Odmerek:

8MG

Farmacevtska oblika:

CAPSULE

Sestava:

LENVATINIB (LENVATINIB MESYLATE) 8MG

Pot uporabe:

ORAL

Enote v paketu:

60X4MG

Tip zastaranja:

Prescription

Terapevtsko območje:

ANTINEOPLASTIC AGENTS

Povzetek izdelek:

Active ingredient group (AIG) number: 0157671005; AHFS:

Status dovoljenje:

APPROVED

Datum dovoljenje:

2017-09-13

Lastnosti izdelka

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