JAMP PAROXETINE TABLETS

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

PAROXETINE (PAROXETINE HYDROCHLORIDE)

Disponibil de la:

JAMP PHARMA CORPORATION

Codul ATC:

N06AB05

INN (nume internaţional):

PAROXETINE

Dozare:

30MG

Forma farmaceutică:

TABLET

Compoziție:

PAROXETINE (PAROXETINE HYDROCHLORIDE) 30MG

Calea de administrare:

ORAL

Unități în pachet:

15G/50G

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2020-11-17

Caracteristicilor produsului

_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
................................................................................................................
5
1.2
Geriatrics
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5
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...