POMALIDOMIDE CAPSULE

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

POMALIDOMIDE

Available from:

NATCO PHARMA (CANADA) INC

ATC code:

L04AX06

INN (International Name):

POMALIDOMIDE

Dosage:

2MG

Pharmaceutical form:

CAPSULE

Composition:

POMALIDOMIDE 2MG

Administration route:

ORAL

Units in package:

100

Prescription type:

Prescription

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2023-02-22

Summary of Product characteristics

_POMALIDOMIDE Product Monograph _
_ _
_ _
_Page 1 of 49_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
POMALIDOMIDE
Pomalidomide
1 mg, 2 mg, 3 mg and 4 mg Capsules for Oral Use
Antineoplastic Agent
Immunomodulatory Agent
ATC Code: L04AX06
Natco Pharma (Canada) Inc.
Date of Preparation:
2000 Argentia Road, Plaza 1, Suite 200
June 15, 2021
Mississauga, Ontario
L5N 1P7
Submission Control No: 245625
_POMALIDOMIDE Product Monograph _
_ _
_ _
_Page 2 of 49_
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
4.4
Administration...................................................................................................
8
4.5
Missed Dose