NORTRIPTYLINE CAPSULE

Riik: Kanada

keel: inglise

Allikas: Health Canada

Osta kohe

Toote omadused Toote omadused (SPC)
05-04-2023

Toimeaine:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE)

Saadav alates:

APOTEX INC

ATC kood:

N06AA10

INN (Rahvusvaheline Nimetus):

NORTRIPTYLINE

Annus:

10MG

Ravimvorm:

CAPSULE

Koostis:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) 10MG

Manustamisviis:

ORAL

Ühikuid pakis:

100

Retsepti tüüp:

Prescription

Terapeutiline ala:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Toote kokkuvõte:

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

Volitamisolek:

APPROVED

Loa andmise kuupäev:

2021-04-06

Toote omadused

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