TEVA-DESVENLAFAXINE TABLET (EXTENDED-RELEASE)

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)

Доступно од:

TEVA CANADA LIMITED

АТЦ код:

N06AX23

INN (Међународно име):

DESVENLAFAXINE

Дозирање:

100MG

Фармацеутски облик:

TABLET (EXTENDED-RELEASE)

Састав:

DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 100MG

Пут администрације:

ORAL

Јединице у пакету:

30/100

Тип рецептора:

Prescription

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2022-02-14

Карактеристике производа

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
.......