PAXIL CR TABLET (EXTENDED-RELEASE)

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

PAROXETINE (PAROXETINE HYDROCHLORIDE)

Dostupné s:

GLAXOSMITHKLINE INC

ATC kód:

N06AB05

INN (Mezinárodní Name):

PAROXETINE

Dávkování:

12.5MG

Léková forma:

TABLET (EXTENDED-RELEASE)

Složení:

PAROXETINE (PAROXETINE HYDROCHLORIDE) 12.5MG

Podání:

ORAL

Jednotky v balení:

30

Druh předpisu:

Prescription

Terapeutické oblasti:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Přehled produktů:

Active ingredient group (AIG) number: 0123131005; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2003-11-27

Charakteristika produktu

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_PAXIL CR, paroxetine hydrochloride Page 1 of 66 _
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
PAXIL CR
Paroxetine Tablets
Controlled release tablets, 12.5 mg and 25 mg paroxetine (as
paroxetine hydrochloride), Oral
USP
Selective Serotonin Reuptake Inhibitor
GlaxoSmithKline Inc.
100 Milverton Drive
Suite 800
Mississauga, Ontario
L5R 4H1
Date of Initial Authorization:
January 05, 2004
Date of Revision:
September 22, 2022
Submission Control Number: 263624
_©_
_2022 GSK group of companies or its licensor _
_Trademarks are owned by or licensed to the GSK group of companies_
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_PAXIL CR, paroxetine hydrochloride Page 2 of 66 _
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RECENT MAJOR LABEL CHANGES
SECTION
DATE
7 WARNINGS AND PRECAUTIONS, Cardiovascular
09/2022
7 WARNINGS AND PRECAUTIONS, Hematologic
10/2021
7 WARNINGS AND PRECAUTIONS, Neurologic
10/2021
7 WARNINGS AND PRECAUTIONS, Psychiatric
10/2021
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female
and Male Potential
06/2020
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
10/2021
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL
CHANGES............................................................................................
2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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5
1
INDICATIONS
..............................................................................................................
5
1.1
Pediatrics
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5
1.2
Geriatrics...........................................................................................................
5
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS A