PMS-AMITRIPTYLINE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

AMITRIPTYLINE HYDROCHLORIDE

Доступна з:

PHARMASCIENCE INC

Код атс:

N06AA09

ІПН (Міжнародна Ім'я):

AMITRIPTYLINE

Дозування:

10MG

Фармацевтична форма:

TABLET

Склад:

AMITRIPTYLINE HYDROCHLORIDE 10MG

Адміністрація маршрут:

ORAL

Одиниць в упаковці:

100/1000

Тип рецепту:

Prescription

Терапевтична области:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Огляд продуктів:

Active ingredient group (AIG) number: 0101524001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

1998-12-11

Характеристики продукта

_pms-AMITRIPTYLINE (amitriptyline chlorhydrate) _
_Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-AMITRIPTYLINE
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg, Oral
USP
Antidepressant
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada H4P 2T4
www.pharmascience.com
Submission Control Number: 277374
Date of Initial Authorization:
December 11, 1998
Date of Revision:
January 5, 2024
_pms-AMITRIPTYLINE (amitriptyline chlorhydrate) _
_Page 2 of 44 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
01/2024
7 WARNINGS AND PRECAUTIONS
01/2024
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
01/2024
7 WARNINGS AND PRECAUTIONS, Neurologic
02/2023
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
...............................................................................
4
1
INDICATIONS
.............................................................................................................................
4
1.1
Pediatrics
.................................................................................................................................
4
1.2
Geriatrics
..................................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...........................................................................
5
4
DOSAGE AND ADMINISTRATION
..............................................................................