JAMP PAROXETINE TABLETS

Страна: Канада

Язык: английский

Источник: Health Canada

Активный ингредиент:

PAROXETINE (PAROXETINE HYDROCHLORIDE)

Доступна с:

JAMP PHARMA CORPORATION

код АТС:

N06AB05

ИНН (Международная Имя):

PAROXETINE

дозировка:

30MG

Фармацевтическая форма:

TABLET

состав:

PAROXETINE (PAROXETINE HYDROCHLORIDE) 30MG

Администрация маршрут:

ORAL

Штук в упаковке:

15G/50G

Тип рецепта:

Prescription

Терапевтические области:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Обзор продуктов:

Active ingredient group (AIG) number: 0123131001; AHFS:

Статус Авторизация:

APPROVED

Дата Авторизация:

2020-11-17

Характеристики продукта

_JAMP Paroxetine Tablets ( paroxetine hydrochloride) _
_Page 1 of 64_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP PAROXETINE TABLETS
Paroxetine Tablets
Tablets, 10 mg, 20 mg and 30 mg paroxetine (as paroxetine
hydrochloride), Oral
USP
Selective Serotonin Reuptake Inhibitor
JAMP Pharma Corporation
1310, rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
November 17, 2020
Date of Revision:
April 27, 2023
Submission Control Number: 269630
_JAMP Paroxetine Tablets ( paroxetine hydrochloride) _
_Page 2 of 64_
_ _
RECENT MAJOR LABEL CHANGES
SECTION
DATE
7 WARNINGS AND PRECAUTIONS, Cardiovascular
04/2023
7 WARNINGS AND PRECAUTIONS, Hematologic
09/2022
7 WARNINGS AND PRECAUTIONS, Immune
09/2022
7 WARNINGS AND PRECAUTIONS, Neurologic
09/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
09/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
09/2022
2 CONTRAINDICATIONS
09/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
..............................................................................................
2
TABLE OF CONTENTS
................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
5
1
INDICATIONS
................................................................................................................
5
1.1
Pediatrics
................................................................................................................
5
1.2
Geriatrics
................................................................................................................
5
2
CONTRAINDICATIONS
...................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...