BELSOMRA TABLET

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

SUVOREXANT

Disponible desde:

MERCK CANADA INC

Código ATC:

N05CJ01

Designación común internacional (DCI):

SUVOREXANT

Dosis:

15MG

formulario farmacéutico:

TABLET

Composición:

SUVOREXANT 15MG

Vía de administración:

ORAL

Unidades en paquete:

30

tipo de receta:

Prescription

Área terapéutica:

MISCELLANEOUS ANXIOLYTICS SEDATIVES AND HYPNOTICS

Resumen del producto:

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

Estado de Autorización:

CANCELLED POST MARKET

Fecha de autorización:

2020-05-14

Ficha técnica

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