NINLARO CAPSULE

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

IXAZOMIB (IXAZOMIB CITRATE)

Tersedia dari:

TAKEDA CANADA INC

Kode ATC:

L01XG03

INN (Nama Internasional):

IXAZOMIB

Dosis:

3MG

Bentuk farmasi:

CAPSULE

Komposisi:

IXAZOMIB (IXAZOMIB CITRATE) 3MG

Rute administrasi :

ORAL

Unit dalam paket:

3

Jenis Resep:

Prescription

Area terapi:

ANTINEOPLASTIC AGENTS

Ringkasan produk:

Active ingredient group (AIG) number: 0158410002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2016-08-04

Karakteristik produk

_NINLARO (as ixazomib citrate) capsules _
_Page 1 of 42_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NINLARO
®
Ixazomib capsules
Capsules, 4 mg, 3 mg and 2.3 mg ixazomib (as ixazomib citrate), Oral
Antineoplastic Agent
Takeda Canada Inc.
22 Adelaide Street West, Suite 3800
Toronto Ontario M5H 4E3
Date of Initial Authorization:
Aug 3, 2016
Date of Revision:
Feb 02, 2024
Submission Control Number: 279731
NINLARO® and the NINLARO Logo® are registered trademarks of
Millennium Pharmaceuticals,
Inc.
TAKEDA™ and the TAKEDA Logo® are registered trademarks of Takeda
Pharmaceutical Company
Limited, used under license.
_NINLARO (as ixazomib citrate) capsules _
_Page 2 of 42_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Skin
02/2024
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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2.
CONTRAINDICATIONS
...................................................................................................
4
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX
.............................................................. 4
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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