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What is nimesulide?

Nimesulide is a non-steroidal anti-inflammatory drug (NSAID) developed by Helsinn Healthcare indicated for the treatment of acute pain and primary dysmenorrhoea.

 

Who is Helsinn?

Helsinn Healthcare is a privately owned Swiss pharmaceutical company founded in 1976. Helsinn’s strategy focuses on developing and licensing innovative drugs, including nimesulide (Original Nimesulide). Helsinn distributes original nimesulide under licences through an international network of selected partners.

 

How should nimesulide be used?

Nimesulide must be prescribed by a licensed physician as second line treatment in the approved indications and in compliance with the recommendations expressed in the Summary of Product Characteristics.

Daily dose is 100mg twice-a-day.

The maximum duration of a treatment course is 15 days and, as for other NSAIDs, treatment should be as short as possible. Nimesulide is not indicated in children younger than 12.

 

Is nimesulide available over the counter?

Nimesulide is a prescription-only drug and must be prescribed by a licensed physician after careful evaluation of the patient’s characteristics and needs.

Except for the topical gel formulation, it is not available “over the counter”.

 

How long has nimesulide been on the market?

Nimesulide has been on the market for more than 25 years and it is estimated that more than 9.18 billion treatment days have been prescribed world-wide so far.

 

Is nimesulide a safe drug?

Recent evaluations on the safety profile of nimesulide confirm that nimesulide has a favourable benefit/risk profile in the approved indications.

The overall safety profile of nimesulide is in line with that of all other NSAIDs.

As with all drugs, it must be used in the most appropriate way to guarantee its best therapeutic value.

 

Why is nimesulide not available in countries such as USA, UK and Germany?

Helsinn has never applied for marketing authorisation to the regulatory authorities in these countries.

Lack of registration does not result from concerns about nimesulide safety profile.

Why in 2010 did the EU commission ask the CHMP to start an evaluation procedure under Article 31?

As the previous Article 107 procedure (which concluded that nimesulide has a favourable benefit/risk profile) focused on the hepatic safety, only limited information regarding the gastrointestinal toxicity profile of nimesulide vis‑à‑vis the gastrointestinal risk of other NSAIDs was taken into account. This new procedure was initiated in February 2010in order to assess the overall benefit/risk profile of nimesulide. For more details see news section.

 

 

 

What was  the outcome of the last referral under Article 31 for nimesulide containing medicinal products for systemic use ?

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of systemic nimesulide-containing medicines continue to outweigh their risks in the treatment of acute pain and primary dysmenorrhoea.

In accordance with the measure adopted in 2009 regarding the treatment duration no longer than 15 days, the CHMP considered that the use of systemic nimesulide for the treatment of chronic conditions would increase the risk of liver injury.

For this reason, the CHMP recommended that systemic nimesulide should no longer be used for the treatment of osteoarthritis.

This Opinion was adopted by the European Commission in January 2012

 

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HELSINN Last Update: 22.02.2013
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