PMS-PAROXETINE TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

PAROXETINE (PAROXETINE HYDROCHLORIDE)

Dostupné s:

PHARMASCIENCE INC

ATC kód:

N06AB05

INN (Mezinárodní Name):

PAROXETINE

Dávkování:

40MG

Léková forma:

TABLET

Složení:

PAROXETINE (PAROXETINE HYDROCHLORIDE) 40MG

Podání:

ORAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Přehled produktů:

Active ingredient group (AIG) number: 0123131007; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2007-04-17

Charakteristika produktu

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_pms-PAROXETINE (paroxetine) _
_Page 1 of 69_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PMS-PAROXETINE
Paroxetine Tablets
Tablets, 10 mg, 20 mg, 30 mg and 40 mg, paroxetine (as paroxetine
hydrochloride), Oral
USP
Selective Serotonin Reuptake Inhibitor
PHARMASCIENCE INC.
6111 Royalmount Ave., Suite 100
Montréal, Canada
H4P 2T4
www.pharmascience.com
Date of Initial Authorization:
OCT 28, 2003
Date of Revision:
December 6, 2022
Submission Control Number: 269920
_ _
_pms-PAROXETINE (paroxetine) _
_Page 2 of 69_
RECENT MAJOR LABEL CHANGES
7 WARNINGS AND PRECAUTIONS, Cardiovascular
12/2022
7 WARNINGS AND PRECAUTIONS, Hematologic
05/2022
7 WARNINGS AND PRECAUTIONS, Immune
05/2022
7 WARNINGS AND PRECAUTIONS, Neurologic
05/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
05/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and Male
Potential
05/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
05/2022
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
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2
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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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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4
DOSAGE AND ADMINISTRATION
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