BELSOMRA TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

SUVOREXANT

Available from:

MERCK CANADA INC

ATC code:

N05CJ01

INN (International Name):

SUVOREXANT

Dosage:

15MG

Pharmaceutical form:

TABLET

Composition:

SUVOREXANT 15MG

Administration route:

ORAL

Units in package:

30

Prescription type:

Prescription

Therapeutic area:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Product summary:

Active ingredient group (AIG) number: 0160930003; AHFS:

Authorization status:

CANCELLED POST MARKET

Authorization date:

2020-05-14

Summary of Product characteristics

_BELSOMRA™ (suvorexant)_
_ _
_Page 1 of 37 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
BELSOMRA
®
Suvorexant
Tablet
10 mg, 15 mg, 20 mg
Oral
Hypnotic
Merck Canada Inc.
16750 route Transcanadienne
Kirkland, QC Canada H9H 4M7
www.merck.ca
Date of Initial Approval:
November 28, 2018
Date of Revision:
March 4, 2021
Submission Control No: 244781
_ _
_BELSOMRA_
_®_
_ (suvorexant)_
_ _
_Page 2 of 37_
RECENT MAJOR LABEL CHANGES
WARNINGS AND PRECAUTIONS
02/2021
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................... 3
1
INDICATIONS
...............................................................................................................
3
1.1
Pediatrics
.............................................................................................................
3
1.2
Geriatrics
.............................................................................................................
3
2
CONTRAINDICATIONS
................................................................................................
3
3
DOSAGE AND
ADMINISTRATION...............................................................................
3
3.1
Dosing Considerations
.........................................................................................
3
3.2
Recommended Dose and Dosage Adjustment
..................................................... 4
3.3
Missed Dose
........................................................................................................
5
4
OVERDOSAGE
.............................................................................................................
5
5
DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING
....................... 5
6
WARNINGS AND PRECAUTIONS
...............................................................................
6
6.1
Special Populations
.............................................................................................
9
6.1.1
Pregnant Women
.........................................................