APO-POMALIDOMIDE CAPSULE
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
15-09-2021
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Active ingredient:
POMALIDOMIDE
Available from:
APOTEX INC
ATC code:
L04AX06
INN (International Name):
POMALIDOMIDE
Dosage:
3MG
Pharmaceutical form:
CAPSULE
Composition:
POMALIDOMIDE 3MG
Administration route:
ORAL
Units in package:
15G/50G
Prescription type:
Prescription
Product summary:
Active ingredient group (AIG) number: 0155290003; AHFS:
Authorization status:
APPROVED
Authorization date:
2023-02-22
Summary of Product characteristics
Page 1 of 66
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-POMALIDOMIDE
Pomalidomide Capsules
1 mg, 2 mg, 3 mg and 4 mg Capsules for Oral Use
Antineoplastic Agent
Immunomodulatory Agent
ATC Code: L04AX06
APOTEX INC.
150 Signet Drive
Toronto, Ontario
Canada M9L 1T9
Date of Initial Approval:
September 15, 2021
Submission Control No: 246958
Page 2 of 66
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 Recommended Dose:
......................................6
4.3
Administration
........................................................................................................................8
4.5
Missed Dose
.........................................................................................................................8
5
OVERDOSAGE
.....................................................................................................................9
6
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
..................................9
7
WARNINGS AND PRECAUTIONS
...........
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