TEVA-CITALOPRAM TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Beszerezhető a:

TEVA CANADA LIMITED

ATC-kód:

N06AB04

INN (nemzetközi neve):

CITALOPRAM

Adagolás:

10MG

Gyógyszerészeti forma:

TABLET

Összetétel:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 10MG

Az alkalmazás módja:

ORAL

db csomag:

100

Recept típusa:

Prescription

Terápiás terület:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Termék összefoglaló:

Active ingredient group (AIG) number: 0136243003; AHFS:

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2010-11-02

Termékjellemzők

TEVA-CITALOPRAM_ _
_Page 1 of 56 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-CITALOPRAM
Citalopram Hydrobromide Tablets
Tablets, 10 mg, 20 mg and 40 mg citalopram (as citalopram
hydrobromide), Oral
Teva Standard
Antidepressant
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Canada
www.tevacanada.com
Submission Control Number: 280059
Date of Initial Authorization:
October 24, 2008
Date of Revision:
February 26, 2024
TEVA-CITALOPRAM_ _
_Page 2 of 56 _
RECENT MAJOR LABEL CHANGES
3 SERIOUS WARNINGS AND PRECAUTIONS
02/2024
7 WARNINGS AND PRECAUTIONS, Hematologic
10/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
10/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
10/2022
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
...................................................