AULIN Gel Ref.[7325] Active ingredients: Nimesulide

Source: Health Products Regulatory Authority (IE)  Revision Year: 2010  Publisher: Helsinn Birex Pharm. Limited, Damastown, Mulhuddart, Dublin 15, Ireland

Product name and form

Aulin 3% w/w Gel.

Pharmaceutical Form

Gel.

Opalescent, pale yellow gel.

Qualitative and quantitative composition

Aulin 3% w/w gel contains 3% w/w nimesulide (1 g of gel contains 30 mg of nimesulide).

Excipients:

Methyl parahydroxybenzoate 0.80% w/w

Propyl parahydroxybenzoate 0.02% w/w

For a full list of excipients, see section 6.1.

Active Ingredient Description
Nimesulide

Nimesulide is a non-steroidal anti-inflammatory drug with analgesic and antipyretic properties which acts as an inhibitor of prostaglandin synthesis enzyme cyclo-oxygenase. Cyclo-oxygenase produces prostaglandins, some of them being implicated in the development and maintenance of inflammation.

List of Excipients

Purified Water
Diethylene glycol monoethyl ether
Caprylcaproyl macrogol glycerides
Carbomers
Disodium edetate
Triethanolamine
Methyl parahydroxybenzoate (E218)
Propyl parahydroxybenzoate (E216)

Pack sizes and marketing

15g, 30g, 50g and 100 g aluminium tubes lined with lacquer made of an epoxyphenolic resin and closed with a polypropylene cap.

Not all pack sizes may be marketed.

Marketing authorization holder

Helsinn Birex Pharm. Limited, Damastown, Mulhuddart, Dublin 15, Ireland

Marketing authorization dates and numbers

PA 0294/018/003

Date of first authorisation: 10 December 1999
Date of last renewal: 10 December 2009

Drugs

Drug Countries
AULIN Italy, Poland, Romania

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