Страна: Канада
мова: англійська
Джерело: Health Canada
PALBOCICLIB
PFIZER CANADA ULC
L01EF01
PALBOCICLIB
100MG
CAPSULE
PALBOCICLIB 100MG
ORAL
21
Prescription
ANTINEOPLASTIC AGENTS
Active ingredient group (AIG) number: 0157970002; AHFS:
APPROVED
2016-03-16
_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 ....................... Прочитайте повний документ