APO-POMALIDOMIDE CAPSULE

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

POMALIDOMIDE

Commercializzato da:

APOTEX INC

Codice ATC:

L04AX06

INN (Nome Internazionale):

POMALIDOMIDE

Dosaggio:

3MG

Forma farmaceutica:

CAPSULE

Composizione:

POMALIDOMIDE 3MG

Via di somministrazione:

ORAL

Confezione:

15G/50G

Tipo di ricetta:

Prescription

Dettagli prodotto:

Active ingredient group (AIG) number: 0155290003; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2023-02-22

Scheda tecnica

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
...........