JAMP PAROXETINE TABLETS

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

PAROXETINE (PAROXETINE HYDROCHLORIDE)

Available from:

JAMP PHARMA CORPORATION

ATC code:

N06AB05

INN (International Name):

PAROXETINE

Dosage:

30MG

Pharmaceutical form:

TABLET

Composition:

PAROXETINE (PAROXETINE HYDROCHLORIDE) 30MG

Administration route:

ORAL

Units in package:

15G/50G

Prescription type:

Prescription

Therapeutic area:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Product summary:

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

Authorization status:

APPROVED

Authorization date:

2020-11-17

Summary of Product characteristics

_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
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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
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5
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...