NORTRIPTYLINE CAPSULE

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE)

Предлага се от:

APOTEX INC

АТС код:

N06AA10

INN (Международно Name):

NORTRIPTYLINE

дозиране:

10MG

Лекарствена форма:

CAPSULE

Композиция:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) 10MG

Начин на приложение:

ORAL

Броя в опаковка:

100

Вид предписание :

Prescription

Терапевтична област:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Каталог на резюме:

Active ingredient group (AIG) number: 0102630002; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2021-04-06

Данни за продукта

_NORTRIPTYLINE (_
_Nortriptyline Hydrochloride Capsules_
_) _
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_ Page 1 of 33_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NORTRIPTYLINE
Nortriptyline Hydrochloride Capsules
Capsules, 10 mg and 25 mg, Oral
USP
Antidepressant
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
APR 01, 2021
Date of Revision:
APRIL 5, 2023
Submission Control Number: 269184
_NORTRIPTYLINE (_
_Nortriptyline Hydrochloride Capsules_
_) _
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_ Page 2 of 33_
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RECENT MAJOR LABEL CHANGES
N/A
N/A
TABLE OF CONTENTS
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SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED._ _
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
4
1
INDICATION
.................................................................................................................
4
1.1
PEDIATRICS
................................................................................................................
4
1.2
GERIATRICS
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS
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4
4
DOSAGE AND ADMINISTRATION
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5
4.1
DOSING CONSIDERATIONS
............................................................................................
5
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
....................................................... 5
4.4
ADMINISTRATION
..............................