KOSELUGO CAPSULE

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

SELUMETINIB (SELUMETINIB SULFATE)

Saatavilla:

ALEXION PHARMA GMBH

ATC-koodi:

L01EE04

INN (Kansainvälinen yleisnimi):

SELUMETINIB

Annos:

10MG

Lääkemuoto:

CAPSULE

Koostumus:

SELUMETINIB (SELUMETINIB SULFATE) 10MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0163981001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2023-09-06

Valmisteyhteenveto

_KOSELUGO_
_TM_
_(selumetinib) _
_Page 1 of 35_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
KOSELUGO
TM
Selumetinib capsules
Capsules,10 mg and 25 mg selumetinib (as selumetinib sulfate), Oral
use
Antineoplastic Agent
Alexion Pharma GmbH
Giesshübelstrasse 30
CH-8045 Zürich, Switzerland
Imported By:
Alexion Pharma Canada Corp.
1004 Middlegate Road, Suite #5000, Mississauga, ON L4Y 1M4
https://alexion.com/worldwide/canada
Submission Control No.: 278054
KOSELUGO
TM
is a trademark of AstraZeneca AB. Used with Permission.
© Alexion Pharma GmbH 2023
Date of Initial
Authorization:
SEP 06, 2023
_ _
_KOSELUGO_
_TM_
_(selumetinib) _
_Page 2 of 35_
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
4
DOSAGE AND ADMINISTRATION
................................................................................
4
4.1
Dosing Considerations
...........................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
....................................................... 4
4.4
Administration
..............