Land: Kanada
Sprache: Englisch
Quelle: Health Canada
POMALIDOMIDE
NATCO PHARMA (CANADA) INC
L04AX06
POMALIDOMIDE
3MG
CAPSULE
POMALIDOMIDE 3MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0155290003; AHFS:
APPROVED
2023-02-22
_NAT-POMALIDOMIDE Product Monograph _ _ _ _ _ _Page 1 of 61_ PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR NAT-POMALIDOMIDE Pomalidomide Capsules 1 mg, 2 mg, 3 mg and 4 mg Antineoplastic Agent Immunomodulatory Agent ATC Code: L04AX06 Natco Pharma (Canada) Inc. Date of Initial Approval: 2000 Argentia Road, Plaza 1, Suite 200 October 08, 2020 Mississauga, Ontario L5N 1P7 Date of Revision: September 16, 2022 Submission Control No: 263035 _NAT-POMALIDOMIDE Product Monograph _ _ _ _ _ _Page 2 of 61_ RECENT MAJOR LABEL CHANGES Not applicable. 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..................................................... 6 4.3 Administration ........................................................................ Lesen Sie das vollständige Dokument