QUVIVIQ TABLET

国: カナダ

言語: 英語

ソース: Health Canada

有効成分:

DARIDOREXANT (DARIDOREXANT HYDROCHLORIDE)

から入手可能:

IDORSIA PHARMACEUTICALS LTD

ATCコード:

N05CJ03

INN（国際名）:

DARIDOREXANT

投薬量:

50MG

医薬品形態:

TABLET

構図:

DARIDOREXANT (DARIDOREXANT HYDROCHLORIDE) 50MG

投与経路:

ORAL

パッケージ内のユニット:

15G/50G

処方タイプ:

Prescription

製品概要:

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

認証ステータス:

APPROVED

承認日:

2023-04-28

製品の特徴

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