MAR-AMITRIPTYLINE TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

AMITRIPTYLINE HYDROCHLORIDE

Beschikbaar vanaf:

MARCAN PHARMACEUTICALS INC

ATC-code:

N06AA09

INN (Algemene Internationale Benaming):

AMITRIPTYLINE

Dosering:

25MG

farmaceutische vorm:

TABLET

Samenstelling:

AMITRIPTYLINE HYDROCHLORIDE 25MG

Toedieningsweg:

ORAL

Eenheden in pakket:

100/1000

Prescription-type:

Prescription

Therapeutisch gebied:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Product samenvatting:

Active ingredient group (AIG) number: 0101524002; AHFS:

Autorisatie-status:

MARKETED

Autorisatie datum:

2015-04-24

Productkenmerken

MAR-AMITRIPTYLINE (Amitriptyline Hydrochlodride Tablets)
Page 1 of 47
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MAR-AMITRIPTYLINE
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral
House Standard
Antidepressant
Marcan Pharmaceuticals Inc.
2 Gurdwara Road, Suite# 112
Ottawa, ON K2E 1A2
Date of Initial Authorization:
AUG 12, 2014
Date of Revision:
JAN 02, 2024
Submission Control Number: 282059
MAR-AMITRIPTYLINE (Amitriptyline Hydrochlodride Tablets)
Page 2 of 47
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
01/2024
7 WARNINGS AND PRECAUTIONS
01/2024
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
01/2024
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
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
....................................................................................................................
4
1.2
Geriatrics
....................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................... 5
4
DOSAGE AND ADMINISTRATION
.................................................................................
5
4.1
Dosing Considerations
...............................................................................................
5
4.2
Recommended Dose and Dosag