AG-CITALOPRAM TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Boleh didapati daripada:

ANGITA PHARMA INC.

Kod ATC:

N06AB04

INN (Nama Antarabangsa):

CITALOPRAM

Dos:

40MG

Borang farmaseutikal:

TABLET

Komposisi:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 40MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0136243002; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2014-09-02

Ciri produk

AG-Citalopram (Citalopram Tablets, USP) Page 1 of
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-CITALOPRAM
AG-Citalopram Tablets
Tablet, 10 mg, 20 mg and 40 mg citalopram (as citalopram
hydrobromide), Oral
USP
Antidepressant
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3 Canada
Date of Initial Authorisation :
FEB 10, 2010
Date of Revision:
JUL 10, 2023
Submission Control No: 276339
AG-Citalopram (Citalopram Tablets, USP) Page 2 of
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hematologic
07/2023
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential
07/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
07/2023
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
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4
1.2
Geriatrics
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4
2 CONTRAINDICATIONS
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4
4 DOSAGE AND ADMINISTRATION
....................................................................................
5
4.1 Dosing Considerations
.............................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
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