DESVENLAFAXINE TABLET (EXTENDED-RELEASE)

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

DESVENLAFAXINE

Verfügbar ab:

SANIS HEALTH INC

ATC-Code:

N06AX23

INN (Internationale Bezeichnung):

DESVENLAFAXINE

Dosierung:

50MG

Darreichungsform:

TABLET (EXTENDED-RELEASE)

Zusammensetzung:

DESVENLAFAXINE 50MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2023-02-06

Fachinformation

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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
_ _
_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