APO-NAPROXEN EC TABLETS TABLET (ENTERIC-COATED)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

NAPROXEN

Dostępny od:

APOTEX INC

Kod ATC:

M01AE02

INN (International Nazwa):

NAPROXEN

Dawkowanie:

250MG

Forma farmaceutyczna:

TABLET (ENTERIC-COATED)

Skład:

NAPROXEN 250MG

Droga podania:

ORAL

Sztuk w opakowaniu:

100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0109634001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2002-11-13

Charakterystyka produktu

_APO-NAPROXEN, APO-NAPROXEN SR, APO-NAPROXEN EC (Naproxen Tablets) _
_Page 1 of 53_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-NAPROXEN
Naproxen Tablets
Tablets, 125 mg, 250 mg, 375 mg and 500 mg, Oral
USP
PR
APO-NAPROXEN SR
Naproxen Sustained-Release Tablets
Sustained-Release Tablets, 750 mg, Oral
Apotex Standard
PR
APO-NAPROXEN EC
Naproxen Enteric-Coated Tablets
Enteric-Coated Tablets, 250 mg, 375 mg and 500 mg, Oral
Apotex Standard
ATC Code: M01AE02
Non-Steroidal Anti-Inflammatory Drug (NSAID)
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Initial Authorization:
December 31, 1982
Date of Revision
July 26, 2023
_ _
Submission Control Number: 272842
_APO-NAPROXEN, APO-NAPROXEN SR, APO-NAPROXEN EC (Naproxen Tablets) _
_Page 2 of 53_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
07/2023
3 SERIOUS WARNING AND PRECAUTIONS BOX
07/2023
7 WARNINGS AND PRECAUTIONS
07/2023
7 WARNINGS AND PRECAUTIONS, 7.1.1 Pregnant Women
07/2023
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
.............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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