NAPROSYN TABLET (ENTERIC-COATED)

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

NAPROXEN

Διαθέσιμο από:

ATNAHS PHARMA UK LIMITED

Φαρμακολογική κατηγορία (ATC):

M01AE02

INN (Διεθνής Όνομα):

NAPROXEN

Δοσολογία:

500MG

Φαρμακοτεχνική μορφή:

TABLET (ENTERIC-COATED)

Σύνθεση:

NAPROXEN 500MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2015-11-05

Αρχείο Π.Χ.Π.

_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