GD-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)

זמין מ:

GENMED A DIVISION OF PFIZER CANADA ULC

קוד ATC:

N06AX23

INN (שם בינלאומי):

DESVENLAFAXINE

כמות:

50MG

טופס פרצבטיות:

TABLET (EXTENDED-RELEASE)

הרכב:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 50MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

7/14/28/30/90

סוג מרשם:

Prescription

איזור תרפויטי:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

leaflet_short:

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

מצב אישור:

CANCELLED PRE MARKET

תאריך אישור:

2020-04-02

מאפייני מוצר

PRODUCT MONOGRAPH
Pr
GD
*
-DESVENLAFAXINE
Desvenlafaxine Succinate
Extended Release Tablets 50 and 100 mg desvenlafaxine as
desvenlafaxine succinate
Antidepressant
GenMed, a Division of Pfizer Canada Inc.
17,300 Trans-Canada Highway
Kirkland, Quebec
H9J 2M5
Date of Preparation:
January 24, 2018
Submission Control No.: 212741
*
GD is a trademark of Pfizer Canada Inc.
GenMed, a division of Pfizer Canada Inc., Licensee
©
Pfizer Canada Inc. 2017
_GD-Desvenlafaxine (desvenlafaxine succinate) 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
....................................................................................................12
DRUG INTERACTIONS
....................................................................................................22
DOSAGE AND ADMINISTRATION
................................................................................26
OVERDOSAGE
...................................................................................................................29
ACTION AND CLINICAL PHARMACOLOGY
...............................................................31
STORAGE AND STABILITY
............................................................................................35
SPECIAL HANDLING INSTRUCTIONS
..........................................................................35
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................35
PART II: SCIENTIFIC INFORMATION
.....................