NORTRIPTYLINE CAPSULE

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE)

Disponible des:

APOTEX INC

Codi ATC:

N06AA10

Designació comuna internacional (DCI):

NORTRIPTYLINE

Dosis:

25MG

formulario farmacéutico:

CAPSULE

Composición:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) 25MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0102630001; AHFS:

Estat d'Autorització:

APPROVED

Data d'autorització:

2021-04-06

Fitxa tècnica

_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
.................................................................................................................
4
2
CONTRAINDICATIONS
..................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS
.....................................................................
4
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
DOSING CONSIDERATIONS
............................................................................................
5
4.2
RECOMMENDED DOSE AND DOSAGE ADJUSTMENT
....................................................... 5
4.4
ADMINISTRATION
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