NORTRIPTYLINE CAPSULE

Land: Canada

Sprog: engelsk

Kilde: Health Canada

Aktiv bestanddel:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE)

Tilgængelig fra:

APOTEX INC

ATC-kode:

N06AA10

INN (International Name):

NORTRIPTYLINE

Dosering:

10MG

Lægemiddelform:

CAPSULE

Sammensætning:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) 10MG

Indgivelsesvej:

ORAL

Enheder i pakken:

100

Recept type:

Prescription

Terapeutisk område:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2021-04-06

Produktets egenskaber

_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
_ _
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
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
..............................