NAPROREX Tablet Ref.[28150] Active ingredients: Naproxen

Source: Υπουργείο Υγείας (CY)  Revision Year: 2018  Publisher: Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

Product name and form

Naprorex 250 mg Tablets.

Naprorex 500 mg Tablets.

Pharmaceutical Form

Tablets.

For Naprorex 250 mg tablets: White, concave, round tablets, 10 mm diameter in size, scored on one side.

For Naprorex 500 mg tablets: White, concave, round tablets, 12 mm diameter in size, scored on one side.

Qualitative and quantitative composition

For Naprorex 250 mg tablets: Each tablet contains 250 mg of naproxen.

For Naprorex 500 mg tablets: Each tablet contains 500 mg of naproxen.

For the 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

Magnesium stearate
Microcrystalline cellulose
Povidone
Sodium starch glycolate

Pack sizes and marketing

Naprorex 250 and 500 mg tablets are packed in Aluminum/PVC blisters of 1x10 and 2x10 tablets.

Not all pack sizes may be marketed.

Marketing authorization holder

Delorbis Pharmaceuticals Ltd., 17 Athinon Street, Ergates Industrial Area, 2643 Ergates, P.O. Box 28629, 2081 Lefkosia, Cyprus, European Union

Marketing authorization dates and numbers

Naprorex 250 tablets: 14662
Naprorex 500 tablets: 14664

Date of first authorisation: 4 April 1994

Drugs

Drug Countries
NAPROREX Cyprus

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