SUNOSI TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

SOLRIAMFETOL (SOLRIAMFETOL HYDROCHLORIDE)

Tilgjengelig fra:

AXSOME MALTA LTD.

ATC-kode:

N06BA14

INN (International Name):

SOLRIAMFETOL

Dosering :

150MG

Legemiddelform:

TABLET

Sammensetning:

SOLRIAMFETOL (SOLRIAMFETOL HYDROCHLORIDE) 150MG

Administreringsrute:

ORAL

Enheter i pakken:

15G/50G

Resept typen:

Prescription

Terapeutisk område:

Wakefulness-Promoting Agents

Produkt oppsummering:

Active ingredient group (AIG) number: 0162888002; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2021-05-13

Preparatomtale

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_Page 1 of 38_
_SUNOSI (solriamfetol)_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SUNOSI®
solriamfetol tablets
Film-coated Tablet, 75 mg and 150 mg solriamfetol (as solriamfetol
hydrochloride), Oral
Psychoanaleptic
Date of Initial Authorization:
August 24, 2022
Axsome Malta
Ltd.
93
Mill Street, Zone 5, Central Business District
Qormi
CBD 5090, Malta
Imported by:
Innomar Strategies Inc.
3470 Superior Crt.
Oakville, Ontario
L6L 0C4
Submission Control Number: 266452
SUNOSI® is a registered trademark of Axsome Malta Ltd. or its
affiliates
©2021 Axsome Malta Ltd. All rights reserved.
_ _
_SUNOSI (solriamfetol) _
_Page 2 of 38 _
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
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
................................................................................
5
4.1
Dosing Considerations
.............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.3
Administration
.........................................................................................................
6
4.4
Missed Dose
...........................................