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NAPROXEN Tablet (2018)

Product Name and Form

Naproxen 250mg Tablets.

Pharmaceutical form

Tablet.

White to off white circular flat faced bevelled edge, uncoated tablet with inscription ‘AP’ on one side and breakline on the other side.

Qualitative and Quantitative Composition

Each tablet contains 250 mg naproxen.

Excipient with known effect: Lactose monohydrate.

Each tablet contains 72 mg of lactose monohydrate.

For a full list of excipients, see section 6.1.

List of excipients

Lactose monohydrate
Maize Starch
Polyvinylpyrollidone (povidone K30)
Magnesium stearate (E572)

Pack sizes and Marketing

White polypropylene containers with LDPE closure having tamper evident seal: 1000, 500, 250, 100, 84,70, 56,42, 28, 21, 15 and 14 tablets.

Blister Strips (composed of PVC film and aluminium foil): 84, 70, 56, 42, 28, 21, 15 and 14 tablets.

Marketing authorization holder
Authorization dates

Accord Healthcare Limited, Sage House, 319 Pinner Road, North Harrow, Middlesex, HA1 4HF, United Kingdom

03/09/2007

Marketing authorization number:

PL 20075-0058