AG-CITALOPRAM TABLET

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Disponibil de la:

ANGITA PHARMA INC.

Codul ATC:

N06AB04

INN (nume internaţional):

CITALOPRAM

Dozare:

10MG

Forma farmaceutică:

TABLET

Compoziție:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 10MG

Calea de administrare:

ORAL

Unități în pachet:

100

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2014-09-02

Caracteristicilor produsului

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
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2
TABLE OF
CONTENTS.........................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
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1 INDICATIONS
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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
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5
4.1 Dosing Considerations
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5
4.2 Recommended Dose and Dosage Adjustment
......................................................... 6
4.4
Administration
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