JAMP PAROXETINE TABLETS

国家: 加拿大

语言: 英文

来源: Health Canada

有效成分:

PAROXETINE (PAROXETINE HYDROCHLORIDE)

可用日期:

JAMP PHARMA CORPORATION

ATC代码:

N06AB05

INN（国际名称）:

PAROXETINE

剂量:

30MG

药物剂型:

TABLET

组成:

PAROXETINE (PAROXETINE HYDROCHLORIDE) 30MG

给药途径:

ORAL

每包单位数:

15G/50G

处方类型:

Prescription

治疗领域:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

產品總結:

Active ingredient group (AIG) number: 0123131001; AHFS:

授权状态:

APPROVED

授权日期:

2020-11-17

产品特点

_JAMP Paroxetine Tablets ( paroxetine hydrochloride) _
_Page 1 of 64_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
JAMP PAROXETINE TABLETS
Paroxetine Tablets
Tablets, 10 mg, 20 mg and 30 mg paroxetine (as paroxetine
hydrochloride), Oral
USP
Selective Serotonin Reuptake Inhibitor
JAMP Pharma Corporation
1310, rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
November 17, 2020
Date of Revision:
April 27, 2023
Submission Control Number: 269630
_JAMP Paroxetine Tablets ( paroxetine hydrochloride) _
_Page 2 of 64_
_ _
RECENT MAJOR LABEL CHANGES
SECTION
DATE
7 WARNINGS AND PRECAUTIONS, Cardiovascular
04/2023
7 WARNINGS AND PRECAUTIONS, Hematologic
09/2022
7 WARNINGS AND PRECAUTIONS, Immune
09/2022
7 WARNINGS AND PRECAUTIONS, Neurologic
09/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
09/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health:
Female and Male Potential
09/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
09/2022
2 CONTRAINDICATIONS
09/2022
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
.......................................................................
5
1
INDICATIONS
................................................................................................................
5
1.1
Pediatrics
................................................................................................................
5
1.2
Geriatrics
................................................................................................................
5
2
CONTRAINDICATIONS
...................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...