IBRANCE TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

PALBOCICLIB

Commercializzato da:

PFIZER CANADA ULC

Codice ATC:

L01EF01

INN (Nome Internazionale):

PALBOCICLIB

Dosaggio:

75MG

Forma farmaceutica:

TABLET

Composizione:

PALBOCICLIB 75MG

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Area terapeutica:

ANTINEOPLASTIC AGENTS

Dettagli prodotto:

Active ingredient group (AIG) number: 0157970001; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2019-10-31

Scheda tecnica

_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
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4
1
INDICATIONS
...............................................................................................................
4
1.1
Pediatrics
................................................................................................................
4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATION
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5
4.1
Dosing Considerations
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5
4.2
Recommended Dose and Dosage Adjustment
.......................