QUVIVIQ TABLET

Quốc gia: Canada

Ngôn ngữ: Tiếng Anh

Nguồn: Health Canada

Thành phần hoạt chất:

DARIDOREXANT (DARIDOREXANT HYDROCHLORIDE)

Sẵn có từ:

IDORSIA PHARMACEUTICALS LTD

Mã ATC:

N05CJ03

INN (Tên quốc tế):

DARIDOREXANT

Liều dùng:

50MG

Dạng dược phẩm:

TABLET

Thành phần:

DARIDOREXANT (DARIDOREXANT HYDROCHLORIDE) 50MG

Tuyến hành chính:

ORAL

Các đơn vị trong gói:

15G/50G

Loại thuốc theo toa:

Prescription

Tóm tắt sản phẩm:

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

Tình trạng ủy quyền:

APPROVED

Ngày ủy quyền:

2023-04-28

Đặc tính sản phẩm

_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
......................................................................................................