QUVIVIQ TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

DARIDOREXANT (DARIDOREXANT HYDROCHLORIDE)

Tersedia dari:

IDORSIA PHARMACEUTICALS LTD

Kode ATC:

N05CJ03

INN (Nama Internasional):

DARIDOREXANT

Dosis:

50MG

Bentuk farmasi:

TABLET

Komposisi:

DARIDOREXANT (DARIDOREXANT HYDROCHLORIDE) 50MG

Rute administrasi :

ORAL

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Ringkasan produk:

Active ingredient group (AIG) number: 0164601002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2023-04-28

Karakteristik produk

_QUVIVIQ_
_TM_
_ (daridorexant) _
_Page 1 of 28_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
QUVIVIQ
TM
Daridorexant tablets
Tablets, 25 mg and 50 mg tablets daridorexant (as daridorexant
hydrochloride), Oral
Hypnotic
Idorsia Pharmaceuticals Ltd
Hegenheimermattweg 91
4123 Allschwil
Switzerland
Imported and distributed in Canada by
Innomar Strategies Inc.
Oakville, ON L6L 0C4
Canada
Date of Initial Authorization:
April 26, 2023
Date of Revision:
January 08, 2024
Submission Control Number: 276525
_ _
_QUVIVIQ_
_TM_
_ (daridorexant) _
_Page 2 of 28_
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
4.5
Missed Dose
......................................................................................................