NAT-POMALIDOMIDE CAPSULE

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

POMALIDOMIDE

Διαθέσιμο από:

NATCO PHARMA (CANADA) INC

Φαρμακολογική κατηγορία (ATC):

L04AX06

INN (Διεθνής Όνομα):

POMALIDOMIDE

Δοσολογία:

3MG

Φαρμακοτεχνική μορφή:

CAPSULE

Σύνθεση:

POMALIDOMIDE 3MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

15G/50G

Τρόπος διάθεσης:

Prescription

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2023-02-22

Αρχείο Π.Χ.Π.

_NAT-POMALIDOMIDE Product Monograph _
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_Page 1 of 61_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NAT-POMALIDOMIDE
Pomalidomide Capsules
1 mg, 2 mg, 3 mg and 4 mg
Antineoplastic Agent
Immunomodulatory Agent
ATC Code: L04AX06
Natco Pharma (Canada) Inc.
Date of Initial Approval:
2000 Argentia Road, Plaza 1, Suite 200
October 08, 2020
Mississauga, Ontario
L5N 1P7
Date of Revision:
September 16, 2022
Submission Control No: 263035
_NAT-POMALIDOMIDE Product Monograph _
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_Page 2 of 61_
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
4.3 Administration
........................................................................