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Published on 30 September 2016

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EU marketing authorisation granted for Teva’s Aerivio Spiromax®

Teva Pharmaceutical Industries Ltd has announced that it has received EU marketing authorisation for Aerivio Spiromax® (fluticasone/salmeterol 500/50)1 as a maintenance bronchodilator treatment for adult patients with severe asthma and chronic obstructive pulmonary disease (COPD).

 

Teva Pharmaceutical Industries Ltd has announced that it has received EU marketing authorisation for Aerivio Spiromax® (fluticasone/salmeterol 500/50)1 as a maintenance bronchodilator treatment for adult patients with severe asthma and chronic obstructive pulmonary disease (COPD).

 

Aerivio Spiromax®contains a fixed dose combination of fluticasone propionate, an inhaled corticosteroid to treat the underlying inflammation in asthma and COPD, and salmeterol xinafoate, a long-acting beta-agonist, being delivered via the award-winning2 Spiromax® inhaler.

 

We are excited about the European approval of Aerivio Spiromax® that can give patients with severe asthma and COPD the possibility to benefit from this widely used fixed dose combination in the award-winning Spiromax® inhaler,” said Luca Frangoni, VP Head of Respiratory Europe. “It is an important goal of our growing respiratory franchise to bring a wide range of new treatment options to patients and healthcare professionals; from innovative treatments and value-adding services to advanced inhalers such as Spiromax®.”

 

The Spiromax® inhaler has received a Medical Design Excellence Award that recognises significant advances in medical product design. The inhaler is primed by opening the cover and a click confirms it is ready for use. It provides dosing confirmation for patients through a subtle taste and precise dose indicator. Spiromax®delivers consistent dosing of the medicines from first dose to last.

 

With the approval of Aerivio Spiromax® Teva adds another established fixed dose combination of ICS/LABA (inhaled corticosteroid with long-acting beta-agonist) to its inhaler family. DuoResp Spiromax®, the combination of budesonide and formoterol fumarate dihydrate, already received EU marketing authorisation for the treatment of asthma and COPD in May 2014.

 

References

  1. European Medicines Agency, Aerivio Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002752/WC500212329.pdf  Date accessed: September 2016
  2. Medical Design Excellence Awards 2015. Silver award winner, Drug-Delivery Devices and Combination Products category. Available from: http://mdeawards.mddionline.com/2015-winners . Date accessed: September 2016


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