AURO-CITALOPRAM TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Disponible depuis:

AURO PHARMA INC

Code ATC:

N06AB04

DCI (Dénomination commune internationale):

CITALOPRAM

Dosage:

20MG

forme pharmaceutique:

TABLET

Composition:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 20MG

Mode d'administration:

ORAL

Unités en paquet:

30/100/500

Type d'ordonnance:

Prescription

Domaine thérapeutique:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Descriptif du produit:

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

Statut de autorisation:

APPROVED

Date de l'autorisation:

2006-02-16

Résumé des caractéristiques du produit

_AURO-CITALOPRAM_
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Page 1 of 67
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-CITALOPRAM
citalopram hydrobromide
Tablets, 20 and 40 mg citalopram (base), Oral
Antidepressant
AURO PHARMA
INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
CANADA
Date of Initial Authorization:
March 11, 2011
Submission Control Number: 264092
Date of Revision:
October 13, 2022
_AURO-CITALOPRAM_
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Page 2 of 67
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_AURO-CITALOPRAM_
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Page 3 of 67
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RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Hematologic
10/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential
10/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
10/2022
TABLE OF CONTENTS
Sections or subsections that are not applicable at the time of
authorization are not listed.
RECENT MAJOR LABEL CHANGES
...........................................................................................
3
TABLE OF
CONTENTS.............................................................................................................
3
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 6
1 INDICATIONS
.....................................................................................................................
6
1.1 Pediatrics
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6
1.2 Geriatrics
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6
2 CONTRAINDICATIONS
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6
4 DOSAGE AND ADMINISTRATION
........................................................................................
7
4.1 Dosing Considerations
..........................................................................................
7
4.2 Recommended Dose and Dosage Adjustment
....................................................... 8
4.4 Administration
.