REDDY-POMALIDOMIDE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

POMALIDOMIDE

Available from:

DR REDDY'S LABORATORIES LTD

ATC code:

L04AX06

INN (International Name):

POMALIDOMIDE

Dosage:

2MG

Pharmaceutical form:

CAPSULE

Composition:

POMALIDOMIDE 2MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Product summary:

Active ingredient group (AIG) number: 0155290002; AHFS:

Authorization status:

APPROVED

Authorization date:

2023-02-20

Summary of Product characteristics

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
...............................................................................