AG-CITALOPRAM TABLET

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Commercializzato da:

ANGITA PHARMA INC.

Codice ATC:

N06AB04

INN (Nome Internazionale):

CITALOPRAM

Dosaggio:

40MG

Forma farmaceutica:

TABLET

Composizione:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 40MG

Via di somministrazione:

ORAL

Confezione:

30/100

Tipo di ricetta:

Prescription

Area terapeutica:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Dettagli prodotto:

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

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2014-09-02

Scheda tecnica

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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