AURO-CITALOPRAM TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Boleh didapati daripada:

AURO PHARMA INC

Kod ATC:

N06AB04

INN (Nama Antarabangsa):

CITALOPRAM

Dos:

40MG

Borang farmaseutikal:

TABLET

Komposisi:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 40MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/100/300

Jenis preskripsi:

Prescription

Kawasan terapeutik:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Ringkasan produk:

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

Status kebenaran:

APPROVED

Tarikh kebenaran:

2006-02-16

Ciri produk

_AURO-CITALOPRAM_
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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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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
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1 INDICATIONS
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6
1.1 Pediatrics
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6
1.2 Geriatrics
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6
2 CONTRAINDICATIONS
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4 DOSAGE AND ADMINISTRATION
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7
4.1 Dosing Considerations
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7
4.2 Recommended Dose and Dosage Adjustment
....................................................... 8
4.4 Administration
.