AG-CITALOPRAM TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

זמין מ:

ANGITA PHARMA INC.

קוד ATC:

N06AB04

INN (שם בינלאומי):

CITALOPRAM

כמות:

10MG

טופס פרצבטיות:

TABLET

הרכב:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 10MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

leaflet_short:

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

מצב אישור:

APPROVED

תאריך אישור:

2014-09-02

מאפייני מוצר

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