RIVA-PAROXETINE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE)

Pieejams no:

LABORATOIRE RIVA INC.

ATĶ kods:

N06AB05

SNN (starptautisko nepatentēto nosaukumu):

PAROXETINE

Deva:

10MG

Zāļu forma:

TABLET

Kompozīcija:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) 10MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

30/100/250

Receptes veids:

Prescription

Ārstniecības joma:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Produktu pārskats:

Active ingredient group (AIG) number: 0123131003; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2004-01-09

Produkta apraksts

_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
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
2
1
INDICATIONS
..............................................................................................................
4
1.1
Pediatrics
...................................................................................................................
4
1.2
Geriatrics
...................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
............................................................ 5
4
DOSAGE AND ADMINISTRATI