NORTRIPTYLINE CAPSULE

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ixtrih issa

Ingredjent attiv:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE)

Disponibbli minn:

APOTEX INC

Kodiċi ATC:

N06AA10

INN (Isem Internazzjonali):

NORTRIPTYLINE

Dożaġġ:

10MG

Għamla farmaċewtika:

CAPSULE

Kompożizzjoni:

NORTRIPTYLINE (NORTRIPTYLINE HYDROCHLORIDE) 10MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2021-04-06

Karatteristiċi tal-prodott

                                _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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