IBRANCE CAPSULE

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

PALBOCICLIB

Mevcut itibaren:

PFIZER CANADA ULC

ATC kodu:

L01EF01

INN (International Adı):

PALBOCICLIB

Doz:

125MG

Farmasötik formu:

CAPSULE

Kompozisyon:

PALBOCICLIB 125MG

Uygulama yolu:

ORAL

Paketteki üniteler:

21

Reçete türü:

Prescription

Terapötik alanı:

ANTINEOPLASTIC AGENTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2016-03-16

Ürün özellikleri

_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
..............................................................................................................
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
............................................................ 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
.......................