PRIVA-PAROXETINE TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE)

Доступно од:

PHARMAPAR INC

АТЦ код:

N06AB05

INN (Међународно име):

PAROXETINE

Дозирање:

10MG

Фармацеутски облик:

TABLET

Састав:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) 10MG

Пут администрације:

ORAL

Јединице у пакету:

100/500

Тип рецептора:

Prescription

Терапеутска област:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Резиме производа:

Active ingredient group (AIG) number: 0123131003; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2022-07-29

Карактеристике производа

_Priva-PAROXETINE _
_Page 1 of 53 _
PRODUCT MONOGRAPH
PR PRIVA-PAROXETINE
Paroxetine Tablets USP
10 mg, 20 mg, 30 mg paroxetine (as paroxetine hydrochloride
hemihydrate)
ANTIDEPRESSANT – ANTIOBSESSIONAL – ANTIPANIC – ANXIOLYTIC AGENT
–
SOCIAL PHOBIA (SOCIAL ANXIETY DISORDER) - POSTTRAUMATIC STRESS
DISORDER THERAPY
PHARMAPAR INC.
100-5950, Ch. de la Côte de Liesse
DATE OF PREPARATION:
August 18, 2015
Mont-Royal
QC, H4T 1E2
Control # 186135
_Priva-PAROXETINE _
_Page 2 of 53 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL
INFORMATION.................................................................
3
SUMMARY PRODUCT INFORMATION
.....................................................................................
3
INDICATIONS AND CLINICAL USE
...........................................................................................
3
CONTRAINDICATIONS
................................................................................................................
5
WARNINGS AND PRECAUTIONS
...............................................................................................
6
ADVERSE REACTIONS
...............................................................................................................
13
DRUG INTERACTIONS
...............................................................................................................
23
DOSAGE AND ADMINISTRATION
...........................................................................................
28
OVERDOSAGE
.............................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
.........................................................................
31
STORAGE AND STABILITY
.......................................................................................................
33
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................................... 34
PART II: SCIENTIFIC INFORMATION
........................................