IBRANCE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

PALBOCICLIB

Предлага се от:

PFIZER CANADA ULC

АТС код:

L01EF01

INN (Международно Name):

PALBOCICLIB

дозиране:

125MG

Лекарствена форма:

TABLET

Композиция:

PALBOCICLIB 125MG

Начин на приложение:

ORAL

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Терапевтична област:

ANTINEOPLASTIC AGENTS

Каталог на резюме:

Active ingredient group (AIG) number: 0157970003; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2019-10-31

Данни за продукта

_IBRANCE (Palbociclib) – Product Monograph _
_Page 1 of 55_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
IBRANCE
®
Palbociclib
Capsules, 75 mg, 100 mg and 125 mg, oral
Tablets, 75 mg, 100 mg and 125 mg, oral
Protein Kinase Inhibitor
Pfizer Canada ULC
17300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Initial Authorization:
MAR 15, 2016
Date of Revision:
MAR 07, 2024
Submission Control Number: 273901
®
Pfizer Inc.
Pfizer Canada ULC, Licensee
_ _
_IBRANCE (Palbociclib) – Product Monograph _
_Page 2 of 55_
RECENT MAJOR LABEL CHANGES
1 INDICATIONS
03/2024
4 DOSAGE AND ADMINISTRATION
03/2024
7 WARNINGS AND PRECAUTIONS
03/2024
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
......................................................................
4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
................................................................................................................
4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.......................