APO-NAPROXEN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

NAPROXEN

Предлага се от:

APOTEX INC

АТС код:

M01AE02

INN (Международно Name):

NAPROXEN

дозиране:

250MG

Лекарствена форма:

TABLET

Композиция:

NAPROXEN 250MG

Начин на приложение:

ORAL

Броя в опаковка:

100/1000

Вид предписание :

Prescription

Терапевтична област:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Каталог на резюме:

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

Статус Оторизация:

MARKETED

Дата Оторизация:

1982-12-31

Данни за продукта

_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
.................................................................................................................
4
1.1
Pediatrics
......................................................................................................................
4
1.2
Geriatrics
......................................................................................................................
4
2
CONTRAINDICATIONS
.....................................................................................................
5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
..................................