NORTRIPTYLINE CAPSULE

Country: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE)

Доступно од:

APOTEX INC

АТЦ код:

N06AA10

INN (Међународно име):

NORTRIPTYLINE

Дозирање:

10MG

Фармацеутски облик:

CAPSULE

Састав:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) 10MG

Пут администрације:

ORAL

Јединице у пакету:

100

Тип рецептора:

Prescription

Терапеутска област:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Резиме производа:

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

Статус ауторизације:

APPROVED

Датум одобрења:

2021-04-06

Карактеристике производа

_NORTRIPTYLINE (_
_Nortriptyline Hydrochloride Capsules_
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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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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
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