PMS-AMITRIPTYLINE TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

AMITRIPTYLINE HYDROCHLORIDE

Mevcut itibaren:

PHARMASCIENCE INC

ATC kodu:

N06AA09

INN (International Adı):

AMITRIPTYLINE

Doz:

50MG

Farmasötik formu:

TABLET

Kompozisyon:

AMITRIPTYLINE HYDROCHLORIDE 50MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100/1000

Reçete türü:

Prescription

Terapötik alanı:

TRICYCLICS AND OTHER NOREPINEPHRINE-REUPTAKE INHIBITORS

Ürün özeti:

Active ingredient group (AIG) number: 0101524003; AHFS:

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

1998-12-11

Ürün özellikleri

_pms-AMITRIPTYLINE (amitriptyline chlorhydrate) _
_Page 1 of 44 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PMS-AMITRIPTYLINE
Amitriptyline Hydrochloride Tablets
Tablets, 10 mg, 25 mg, 50 mg, 75 mg and 100 mg, Oral
USP
Antidepressant
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada H4P 2T4
www.pharmascience.com
Submission Control Number: 277374
Date of Initial Authorization:
December 11, 1998
Date of Revision:
January 5, 2024
_pms-AMITRIPTYLINE (amitriptyline chlorhydrate) _
_Page 2 of 44 _
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
7 WARNINGS AND PRECAUTIONS, Neurologic
02/2023
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
..................................................................................................................................
4
2
CONTRAINDICATIONS
................................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...........................................................................
5
4
DOSAGE AND ADMINISTRATION
..............................................................................