AG-AMITRIPTYLINE TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

AMITRIPTYLINE HYDROCHLORIDE

Beschikbaar vanaf:

ANGITA PHARMA INC.

ATC-code:

N06AA09

INN (Algemene Internationale Benaming):

AMITRIPTYLINE

Dosering:

10MG

farmaceutische vorm:

TABLET

Samenstelling:

AMITRIPTYLINE HYDROCHLORIDE 10MG

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: 0101524001; AHFS:

Autorisatie-status:

APPROVED

Autorisatie datum:

2018-09-19

Productkenmerken

_AG-Amitriptyline (Amitriptyline Hydrochloride Tablets)_
_ _
_Page 1 of 32 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-AMITRIPTYLINE
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg, 50 mg and 75 mg, Oral
House Standard
Antidepressant
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Québec
J4B 5H3, Canada
Date of Initial Authorization:
June 26, 2018
Date of Revision:
March 21, 2023
Submission Control Number: 272524
_AG-Amitriptyline (Amitriptyline _
_Hydrochloride Tablets)_
_ _
_)_
_ _
_Page 2 of 32 _
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Neurologic
03/2023
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
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4
2
CONTRAINDICATIONS
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4
3
SERIOUS WARNINGS AND PRECAUTIONS
BOX...................................................................
5
4
DOSAGE AND ADMINISTRATION
..................................................................................
5
4.1
Dosing Considerations
...............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
...................................................