RIVA-PAROXETINE TABLET

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE)

Disponível em:

LABORATOIRE RIVA INC.

Código ATC:

N06AB05

DCI (Denominação Comum Internacional):

PAROXETINE

Dosagem:

20MG

Forma farmacêutica:

TABLET

Composição:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) 20MG

Via de administração:

ORAL

Unidades em pacote:

100/500

Tipo de prescrição:

Prescription

Área terapêutica:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Resumo do produto:

Active ingredient group (AIG) number: 0123131002; AHFS:

Status de autorização:

APPROVED

Data de autorização:

2004-01-09

Características técnicas

_Page 1 of 56_
_RIVA-PAROXETINE – Product Monograph_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
RIVA-PAROXETINE
Paroxetine Tablets
Tablets, 10 mg, 20 mg and 30 mg paroxetine (as paroxetine
hydrochloride hemihydrate), Oral
USP
Selective Serotonin Reuptake Inhibitor
LABORATOIRE RIVA INC.
660 Boul. Industriel
Blainville, Quebec
J7C 3V4
www.labriva.com
Submission Control No.: 276263
Date of Initial Authorization:
JAN
9, 2004
Date of Revision:
JUL 10, 2023
_RIVA-PAROXETINE – Product Monograph _
_Page 2 of 56_
RECENT MAJOR LABEL CHANGES
SECTION
DATE
7 WARNINGS AND PRECAUTIONS, Cardiovascular
7 WARNINGS AND PRECAUTIONS, Hematologic
07/2022
7 WARNINGS AND PRECAUTIONS, Immune
05/2021
7 WARNINGS AND PRECAUTIONS, Neurologic
07/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female and
Male Potential
05/2021
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
07/2022
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
.....................................................................
2
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATI