TEVA-CITALOPRAM TABLET

Land: Kanada

Språk: engelska

Källa: Health Canada

Aktiva substanser:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Tillgänglig från:

TEVA CANADA LIMITED

ATC-kod:

N06AB04

INN (International namn):

CITALOPRAM

Dos:

20MG

Läkemedelsform:

TABLET

Sammansättning:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG

Administreringssätt:

ORAL

Enheter i paketet:

30/100/500

Receptbelagda typ:

Prescription

Terapiområde:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produktsammanfattning:

Active ingredient group (AIG) number: 0136243001; AHFS:

Bemyndigande status:

APPROVED

Tillstånd datum:

2010-11-02

Produktens egenskaper

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
...................................................