Land: Kanada
Språk: engelska
Källa: Health Canada
POMALIDOMIDE
DR REDDY'S LABORATORIES LTD
L04AX06
POMALIDOMIDE
4MG
CAPSULE
POMALIDOMIDE 4MG
ORAL
15G/50G
Prescription
Active ingredient group (AIG) number: 0155290004; AHFS:
APPROVED
2023-02-20
Page 1 of 59 PRODUCT MONOGRAPH INCLUDING PATIENT MEDICATION INFORMATION PR REDDY-POMALIDOMIDE Pomalidomide Capsules Capsules, 1 mg, 2 mg, 3 mg and 4 mg, for oral use Antineoplastic Agent Immunomodulatory Agent ATC Code: L04AX06 Manufactured By: Date of Initial Approval: DR. REDDY’S LABORATORIES LTD., August 21, 2020 Bachupally - 500090 India Imported and Distributed By: Date of Revision: DR. REDDY’S LABORATORIES CANADA INC. December 7, 2022 Mississauga ON L4W 4Y1 Canada Submission Control Number: 265686 Page 2 of 59 RECENT MAJOR LABEL CHANGES 7 Warnings and Precautions, Infections 08/2021 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 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 ..................................................................................... 6 4.1 Dosing Considerations ....................................................................................................... 6 4.2 Recommended Dose and Dosage Adjustment ................................................................. 6 4.3 Administration ............................................................................... Läs hela dokumentet