SANDOZ POMALIDOMIDE CAPSULE

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

POMALIDOMIDE

Beszerezhető a:

SANDOZ CANADA INCORPORATED

ATC-kód:

L04AX06

INN (nemzetközi neve):

POMALIDOMIDE

Adagolás:

1MG

Gyógyszerészeti forma:

CAPSULE

Összetétel:

POMALIDOMIDE 1MG

Az alkalmazás módja:

ORAL

db csomag:

15G/50G

Recept típusa:

Prescription

Termék összefoglaló:

Active ingredient group (AIG) number: 0155290001; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2023-02-22

Termékjellemzők

_SANDOZ POMALIDOMIDE (pomalidomide) _
_Page 1 of 70_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SANDOZ® POMALIDOMIDE
Pomalidomide capsules
Capsules, 1 mg, 2 mg, 3 mg and 4 mg, Oral
Antineoplastic Agent
Immunomodulatory Agent
ATC Code: L04AX06
Sandoz Canada Inc.
110 de Lauzon Street
Boucherville, Quebec
J4B 1E6
Date of Initial Authorization:
December 30, 2021
Submission Control Number: 246308
_ _
_SANDOZ POMALIDOMIDE (pomalidomide) _
_Page 2 of 70_
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...................................................................................6
4.1
Dosing Considerations
.........................................................................................6
4.2
Recommended Dose and Dosage
Adjustment.......................................................6
4.3
Administration
.....................................................................................................8
4.