AG-CITALOPRAM TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Mevcut itibaren:

ANGITA PHARMA INC.

ATC kodu:

N06AB04

INN (International Adı):

CITALOPRAM

Doz:

20MG

Farmasötik formu:

TABLET

Kompozisyon:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG

Uygulama yolu:

ORAL

Paketteki üniteler:

30/100/500

Reçete türü:

Prescription

Terapötik alanı:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2014-09-02

Ürün özellikleri

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
.............................................................................................................
4
1.2
Geriatrics
.............................................................................................................
4
2 CONTRAINDICATIONS
....................................................................................................
4
4 DOSAGE AND ADMINISTRATION
....................................................................................
5
4.1 Dosing Considerations
.............................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
....................................