AG-AMITRIPTYLINE TABLET

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

AMITRIPTYLINE HYDROCHLORIDE

Доступна з:

ANGITA PHARMA 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:

2018-09-19

Характеристики продукта

_AG-Amitriptyline (Amitriptyline Hydrochloride Tablets)_
_ _
_Page 1 of 32 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-AMITRIPTYLINE
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral
House Standard
Antidepressant
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Québec
J4B 5H3, Canada
Date of Initial Authorization:
June 26, 2018
Date of Revision:
March 21, 2023
Submission Control Number: 272524
_AG-Amitriptyline (Amitriptyline _
_Hydrochloride Tablets)_
_ _
_)_
_ _
_Page 2 of 32 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
03/2023
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
..................................................................................
5
4.1
Dosing Considerations
...............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...................................................