RIVA-PAROXETINE TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE)

제공처:

LABORATOIRE RIVA INC.

ATC 코드:

N06AB05

INN (국제 이름):

PAROXETINE

복용량:

20MG

약제 형태:

TABLET

구성:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) 20MG

관리 경로:

ORAL

패키지 단위:

100/500

처방전 유형:

Prescription

치료 영역:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

제품 요약:

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

승인 상태:

APPROVED

승인 날짜:

2004-01-09

제품 특성 요약

_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