NAPROSYN Tablet Ref.[50769] Active ingredients: Naproxen

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2018  Publisher: Atnahs Pharma UK Limited, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom

Product name and form

Naprosyn 500mg Tablets.

Pharmaceutical Form

Tablet.

Naprosyn 500mg Tablets: Oblong, yellow uncoated tablet embossed “NPR LE 500” on one face with a breakline on the other.

Qualitative and quantitative composition

Naprosyn 500mg Tablets: Each tablet contains 500mg naproxen.

For full list of excipients, see section 6.1.

Active Ingredient Description
Naproxen

Naproxen is a non-steroidal anti-inflammatory analgesic compound with antipyretic properties as has been demonstrated in classical animal test systems. Naproxen exhibits its anti-inflammatory effect even in adrenalectomised animals, indicating that its action is not mediated through the pituitary-adrenal axis.

List of Excipients

Povidone
Croscarmellose sodium
Magnesium stearate
Iron oxide E 172
Water

Pack sizes and marketing

Clear or opaque PVC blister packaging with aluminium lidding in cartons, containing 56 tablets.

Marketing authorization holder

Atnahs Pharma UK Limited, Sovereign House, Miles Gray Road, Basildon, Essex, SS14 3FR, United Kingdom

Marketing authorization dates and numbers

PL 43252/0005

Date of first authorisation: 31 May 1996
Date of latest renewal: 09 February 2009

Drugs

Drug Countries
NAPROSYN Australia, Canada, Ecuador, Estonia, Spain, Ireland, Italy, Malta, New Zealand, Turkey, United Kingdom, United States, South Africa

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