DESVENLAFAXINE TABLET (EXTENDED-RELEASE)

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

DESVENLAFAXINE

Disponible des:

SANIS HEALTH INC

Codi ATC:

N06AX23

Designació comuna internacional (DCI):

DESVENLAFAXINE

Dosis:

50MG

formulario farmacéutico:

TABLET (EXTENDED-RELEASE)

Composición:

DESVENLAFAXINE 50MG

Vía de administración:

ORAL

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Resumen del producto:

Active ingredient group (AIG) number: 0152509001; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2023-02-06

Fitxa tècnica

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_DESVENLAFAXINE PRODUCT MONOGRAPH PAGE 1 OF 51 _
PRODUCT MONOGRAPH
PR
DESVENLAFAXINE
Desvenlafaxine Extended-Release Tablets
Extended-release tablets, 50 mg and 100 mg Desvenlafaxine, Oral
Antidepressant
SANIS HEALTH INC.
1 PRESIDENT'S CHOICE CIRCLE
BRAMPTON, ONTARIO
L6Y 5S5
SUBMISSION CONTROL NUMBER: 270697
DATE OF
PREPARATION:
FEB
06, 2023
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_DESVENLAFAXINE PRODUCT MONOGRAPH PAGE 2 OF 51 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
11
DRUG INTERACTIONS
.........................................................................................................
21
DOSAGE AND ADMINISTRATION
.....................................................................................
24
OVERDOSAGE
........................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
28
STORAGE AND STABILITY
.................................................................................................
31
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
31
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 31
PART II: SCIENTIFIC INFORMATION
...............................................................................
33
P