TEVA-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)

ประเทศ: แคนาดา

ภาษา: อังกฤษ

แหล่งที่มา: Health Canada

สารออกฤทธิ์:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)

มีจำหน่ายจาก:

TEVA CANADA LIMITED

รหัส ATC:

N06AX23

INN (ชื่อสากล):

DESVENLAFAXINE

ปริมาณ:

100MG

แบบฟอร์มเภสัชกรรม:

TABLET (EXTENDED-RELEASE)

องค์ประกอบ:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 100MG

เส้นทางการบริหาร:

ORAL

หน่วยในแพ็คเกจ:

30/100

ประเภทใบสั่งยา:

Prescription

สรุปสินค้า:

Active ingredient group (AIG) number: 0152509002; AHFS:

สถานะการอนุญาต:

APPROVED

วันที่อนุญาต:

2022-02-14

สรุปลักษณะสินค้า

PRODUCT MONOGRAPH
Pr
TEVA-DESVENLAFAXINE
Desvenlafaxine Extended-Release Tablets
50 mg and 100 mg desvenlafaxine (as desvenlafaxine succinate)
Antidepressant
Teva Canada Limited
Date of Revision:
30 Novopharm Court
October 18, 2021
Toronto, Ontario
M1B 2K9
Control No.: 256177
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION..........................................................
3
SUMMARY PRODUCT INFORMATION
................................................................................3
INDICATIONS AND CLINICAL USE
.....................................................................................3
CONTRAINDICATIONS
.........................................................................................................3
WARNINGS AND PRECAUTIONS
.........................................................................................4
ADVERSE
REACTIONS........................................................................................................
11
DRUG INTERACTIONS
........................................................................................................
20
DOSAGE AND ADMINISTRATION
.....................................................................................
23
OVERDOSAGE
.....................................................................................................................
25
ACTION AND CLINICAL
PHARMACOLOGY.....................................................................
26
STORAGE AND STABILITY
................................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
29
DOSAGE FORMS, COMPOSITION AND
PACKAGING....................................................... 30
PART II: SCIENTIFIC INFORMATION
.............................................................................
31
PHARMACEUTICAL INFORMATION
.................................................................................
31
CLINICAL TRIALS
.......