NAPROSYN TABLET (ENTERIC-COATED)

País: Canadá

Idioma: inglés

Fuente: Health Canada

Ingredientes activos:

NAPROXEN

Disponible desde:

ATNAHS PHARMA UK LIMITED

Código ATC:

M01AE02

Designación común internacional (DCI):

NAPROXEN

Dosis:

500MG

formulario farmacéutico:

TABLET (ENTERIC-COATED)

Composición:

NAPROXEN 500MG

Vía de administración:

ORAL

Unidades en paquete:

100/500

tipo de receta:

Prescription

Área terapéutica:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Resumen del producto:

Active ingredient group (AIG) number: 0109634003; AHFS:

Estado de Autorización:

APPROVED

Fecha de autorización:

2015-11-05

Ficha técnica

_Product Monograph Master Template _
_Template Date: September 2020 _
_NAPROSYN_
_ _
_(NAPROXEN)_
_ _ _Page 1 of 44 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
NAPROSYN
®
Naproxen
Enteric-Coated Tablet, 375 & 500 mg, for oral use
Sustained-Release Tablet, 750 mg, for oral use
USP
ATC Code: M01AE02
Non-Steroidal Anti-Inflammatory Drug (NSAID)
Atnahs Pharma UK Limited
Sovereign House, Miles Gray Road
Basildon, Essex SS14 3FR
United Kingdom
https://pharmanovia.com/
Date of Initial Authorization:
December 31, 1995
Date of Revision:
January 10, 2022
Distributed by: Methapharm Inc.
Brantford, Ontario N3S 7X6
Canada
Submission Control No: 255330
NAPROSYN® is a registered trademark of Atnahs Pharma UK Limited, used
under license.
_ _
_Product Monograph Master Template _
_Template Date: September 2020 _
_NAPROSYN (NAPROXEN)_
_Page 2 of 44_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
01/2022
3 SERIOUS WARNING AND PRECAUTIONS BOX
01/2022
7 WARNINGS AND PRECAUTIONS
01/2022
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
01/2022
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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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics...........................................................................................................
4
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNIN