País: Canadá
Idioma: inglés
Fuente: Health Canada
NAPROXEN
ATNAHS PHARMA UK LIMITED
M01AE02
NAPROXEN
750MG
TABLET (EXTENDED-RELEASE)
NAPROXEN 750MG
ORAL
100
Prescription
OTHER NONSTEROIDAL ANTIIMFLAMMATORY AGENTS
Active ingredient group (AIG) number: 0109634005; AHFS:
APPROVED
2015-11-05
_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 .............................................................................................................. 2 PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 4 1 INDICATIONS .............................................................................................................. 4 1.1 Pediatrics .......................................................................................................... 4 1.2 Geriatrics........................................................................................................... 4 2 CONTRAINDICATIONS ................................................................................................. 5 3 SERIOUS WARNIN Leer el documento completo