ACT PAROXETINE TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

PAROXETINE (PAROXETINE HYDROCHLORIDE)

Предлага се от:

ACTAVIS PHARMA COMPANY

АТС код:

N06AB05

INN (Международно Name):

PAROXETINE

дозиране:

10MG

Лекарствена форма:

TABLET

Композиция:

PAROXETINE (PAROXETINE HYDROCHLORIDE) 10MG

Начин на приложение:

ORAL

Броя в опаковка:

30/100

Вид предписание :

Prescription

Терапевтична област:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Каталог на резюме:

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

Статус Оторизация:

CANCELLED POST MARKET

Дата Оторизация:

2020-10-21

Данни за продукта

_ACT Paroxetine Page 1 of 55 _
PRODUCT MONOGRAPH
PR
ACT PAROXETINE
Paroxetine tablets BP
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
Actavis Pharma Company Date of Revision:
6733 Mississauga Road, Suite 400
June 13, 2017
Mississauga, Ontario
L5N 6J5
Submission Control No: 206032
_ACT Paroxetine Page 2 of 55 _
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
..............................……………................
24
DOSAGE AND ADMINISTRATION .............…............................
29
OVERDOSAGE
.......................................………….........................
32
ACTION AND CLINICAL PHARMACOLOGY…..........................
33
STORAGE AND STABILITY
........................................……..........
35
DOSAGE FORMS, COMPOSITION AND PACKAGING…….......
35
PART II:
SCIENTIFIC INFORMATION
..........................…………….….......
37
PHARMACEUTICAL INFORMATION .........................….............
37
CLINICAL TRIALS
...............................................……………......
38
DETAILED PHARMACOLOGY ..............................……………..
41
TOXICOLOGY
.............................…………………………............
43
REFERENCES
.....................................………………………….....
45
PART III:
CONSUMER
INFORMATION.....................…………………..........
50
_ACT Paroxetine Page 3 of 55 _
PR
ACT PAROXETINE
Paroxetin