APO-NAPROXEN TABLET

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

NAPROXEN

Available from:

APOTEX INC

ATC code:

M01AE02

INN (International Name):

NAPROXEN

Dosage:

250MG

Pharmaceutical form:

TABLET

Composition:

NAPROXEN 250MG

Administration route:

ORAL

Units in package:

100/1000

Prescription type:

Prescription

Therapeutic area:

OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS

Product summary:

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

Authorization status:

MARKETED

Authorization date:

1982-12-31

Summary of Product characteristics

_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
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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
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4
2
CONTRAINDICATIONS
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5
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
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