SANDOZ FLUVOXAMINE TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

FLUVOXAMINE MALEATE

Доступно од:

SANDOZ CANADA INCORPORATED

АТЦ код:

N06AB08

INN (Међународно име):

FLUVOXAMINE

Дозирање:

50MG

Фармацеутски облик:

TABLET

Састав:

FLUVOXAMINE MALEATE 50MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Резиме производа:

Active ingredient group (AIG) number: 0122450002; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2019-08-01

Карактеристике производа

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_Sandoz Fluvoxamine _
_Page 1 of 50 _
PRODUCT MONOGRAPH
PR
SANDOZ FLUVOXAMINE
Fluvoxamine maleate
50 mg and 100 mg film-coated tablets, BP
Antidepressant/Antiobsessional agent
Sandoz Canada Inc.
Date of Revision: April 13, 2018
145 Jules-Léger
Boucherville, QC
J4B 7K8
Submission Control No: 199622
_ _
_Sandoz Fluvoxamine _
_Page 2 of 50 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
........................................................ 3
SUMMARY PRODUCT
INFORMATION........................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
12
DRUG INTERACTIONS
.................................................................................................
18
DOSAGE AND ADMINISTRATION
.............................................................................
24
OVERDOSAGE
................................................................................................................
26
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 26
STORAGE AND STABILITY
.........................................................................................
28
DOSAGE FORMS, COMPOSITION AND
PACKAGING............................................. 29
PART II: SCIENTIFIC INFORMATION
..............................................................................
30
PHARMACEUTICAL INFORMATION
.........................................................................
30
CLINICAL TRIALS
.........................................................................................................
31
DETAILED PHARMACOLOGY
........