AMITRIPTYLINE-50 TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

AMITRIPTYLINE HYDROCHLORIDE

Предлага се от:

PRO DOC LIMITEE

АТС код:

N06AA09

INN (Международно Name):

AMITRIPTYLINE

дозиране:

50MG

Лекарствена форма:

TABLET

Композиция:

AMITRIPTYLINE HYDROCHLORIDE 50MG

Начин на приложение:

ORAL

Броя в опаковка:

100/1000

Вид предписание :

Prescription

Терапевтична област:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Каталог на резюме:

Active ingredient group (AIG) number: 0101524003; AHFS:

Статус Оторизация:

MARKETED

Дата Оторизация:

1978-12-31

Данни за продукта

_AMITRIPTYLINE (amitriptyline chlorhydrate) _
_Page 1 of 43 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR AMITRIPTYLINE - 10
PR AMITRIPTYLINE - 25
PR AMITRIPTYLINE - 50
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg and 50 mg, Oral
USP
Antidepressant
PRO DOC LTÉE.
2925 boul. Industriel
Laval, Quebec
H7L 3W9
Submission Control Number: 283162
Date of Initial Authorization:
AUG
09,
2012
Date of Revision:
FEB
16, 2024
_AMITRIPTYLINE (amitriptyline chlorhydrate) _
_Page 2 of 43 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
02/2024
7 WARNINGS AND PRECAUTIONS
02/2024
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
02/2024
7 WARNINGS AND PRECAUTIONS, Neurologic
04/2023
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
D