AURO-CITALOPRAM TABLET

Land: Kanada

Tungumál: enska

Heimild: Health Canada

Virkt innihaldsefni:

CITALOPRAM (CITALOPRAM HYDROBROMIDE)

Fáanlegur frá:

AURO PHARMA INC

ATC númer:

N06AB04

INN (Alþjóðlegt nafn):

CITALOPRAM

Skammtar:

40MG

Lyfjaform:

TABLET

Samsetning:

CITALOPRAM (CITALOPRAM HYDROBROMIDE) 40MG

Stjórnsýsluleið:

ORAL

Einingar í pakka:

30/100/300

Gerð lyfseðils:

Prescription

Lækningarsvæði:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Vörulýsing:

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

Leyfisstaða:

APPROVED

Leyfisdagur:

2006-02-16

Vara einkenni

_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_
_ _
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
.............................................................................................................
6
1.2 Geriatrics
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6
2 CONTRAINDICATIONS
........................................................................................................
6
4 DOSAGE AND ADMINISTRATION
........................................................................................
7
4.1 Dosing Considerations
..........................................................................................
7
4.2 Recommended Dose and Dosage Adjustment
....................................................... 8
4.4 Administration
.