ODOMZO CAPSULE

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

SONIDEGIB (SONIDEGIB PHOSPHATE)

Fáanlegur frá:

SUN PHARMACEUTICAL INDUSTRIES LIMITED

ATC númer:

L01XJ02

INN (Alþjóðlegt nafn):

SONIDEGIB

Skammtar:

200MG

Lyfjaform:

CAPSULE

Samsetning:

SONIDEGIB (SONIDEGIB PHOSPHATE) 200MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

15G/50G

Gerð lyfseðils:

Prescription

Lækningarsvæði:

ANTINEOPLASTIC AGENTS

Vörulýsing:

Active ingredient group (AIG) number: 0162314001; AHFS:

Leyfisstaða:

APPROVED

Leyfisdagur:

2022-01-04

Vara einkenni

_ODOMZO_
_®_
_ Product Monograph _
_Page 1 of 35_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ODOMZO
®
Sonidegib Capsules
200 mg sonidegib (as phosphate), oral
Antineoplastic agent (ATC code: L01XX48)
Sun Pharmaceutical Industries Ltd.
Sun House, Plot 201 B/1
Western Express Highway, Goregaon (E)
Mumbai - 400 063
Maharashtra, India
Distributed by:
Sun Pharma Canada Inc.
Brampton, Ontario
L6T 1C1
Submission Control No.: 259210
ODOMZO
®
is a registered trademark of Sun Pharmaceutical Industries Ltd.
Date of Initial Approval:
June
11, 2020
Date of Revision:
December 31, 2021
_ _
_ODOMZO_
_®_
_ Product Monograph _
_Page 2 of 35_
RECENT MAJOR LABEL CHANGES
Not applicable
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 ...............................................................................5
4.1
Dosing Considerations
...........................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
....................................................... 5
4.3
Administration
........................................................................................................
8
4.4
Reconstitution
........................................................................................................
8
4.5
Missed Dose
................................