AG-PAROXETINE TABLET

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE)

Dostupné s:

ANGITA PHARMA INC.

ATC kód:

N06AB05

INN (Mezinárodní Name):

PAROXETINE

Dávkování:

20MG

Léková forma:

TABLET

Složení:

PAROXETINE (PAROXETINE HYDROCHLORIDE HEMIHYDRATE) 20MG

Podání:

ORAL

Jednotky v balení:

15G/50G

Druh předpisu:

Prescription

Terapeutické oblasti:

SELECTIVE-SEROTONIN REUPTAKE INHIBITORS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2018-05-09

Charakteristika produktu

_AG-Paroxetine, paroxetine hydrochloride_
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_Page 1 of 57_
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
AG-PAROXETINE
Paroxetine Tablets
Tablets, 10 mg, 20 mg and 30 mg paroxetine (as paroxetine
hydrochloride hemihydrate), Oral
USP
Selective Serotonin Reuptake Inhibitor
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Date of Initial Authorization:
May 09, 2018
Date of Revision:
September 29, 2023
Submission Control Number: 278985
_AG-Paroxetine, paroxetine hydrochloride_
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_Page 2 of 57_
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RECENT MAJOR LABEL CHANGES
SECTION
DATE
7 WARNINGS AND PRECAUTIONS, Cardiovascular
09/2023
7 WARNINGS AND PRECAUTIONS, Hematologic
08/2022
7 WARNINGS AND PRECAUTIONS, Immune
08/2022
7 WARNINGS AND PRECAUTIONS, Neurologic
08/2022
7 WARNINGS AND PRECAUTIONS, Psychiatric
08/2022
7 WARNINGS AND PRECAUTIONS, Reproductive Health: Female
and Male Potential
08/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
08/2022
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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5
1
INDICATIONS
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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
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