EU Authorizes Teva’s Seffalair® Spiromax® and BroPair® Spiromax®

Teva Pharmaceuticals Europe reported that Seffalair Spiromax and its duplicate BroPair Spiromax (salmeterol xinafoate/fluticasone propionate, 12.75/100 and 12.75/202 micrograms administered doses) have been granted EU Marketing Authorization as a maintenance therapy for asthma in adults and teenagers aged 12 years and over. The first launches are planned to take place in Portugal, Switzerland, Spain and the United Kingdom.

Introducing Seffalair, Spiromax and BroPair Spiromax

Teva’s respiratory pipeline has been expanded with the introduction of Seffalair Spiromax and BroPair Spiromax, giving healthcare professionals another option for treating patients with asthma. The Spiromax® inhaler has been well received by healthcare practitioners and patients since the introduction of DuoResp® Spiromax® (budesonide/formoterol). Asthma patients, depending heavily on inhalers and medication to improve their outcomes are estimated to be approximately 28 million in the European Union.

Paul Blonk, Head of Teva Respiratory Europe says:

“We are excited about the European approval of Seffalair Spiromax and BroPair Spiromax, as an important goal of our respiratory franchise is to bring new treatment options to healthcare professionals who support people living with long-term conditions such as asthma. We want to empower patients to effectively manage their condition through the medicines we provide, whilst also offering cost-effective treatments to healthcare systems.”


About Seffalair Spiromax and BroPair Spiromax (salmeterol xinafoate / fluticasone propionate)

Seffalair Spiromax and BroPair Spiromax are indicated as a regular treatment for asthma in adults and adolescents aged 12 years and older insufficiently managed with corticosteroid inhalers and ‘as needed’ inhaled short-acting β2 agonists.

About Teva Respiratory

Teva Respiratory creates and delivers high-quality treatment solutions for respiratory disorders, such as asthma, COPD and cystic fibrosis. The Teva Respiratory arsenal is dedicated to sophisticated novel respiratory therapies for patients and healthcare professionals by developing revolutionary administration technologies and therapies that meet unmet needs.

Teva’s respiratory pipeline and clinical trial platform are built around drug molecules delivered in patented dry powder formulations, breath-actuated device systems, and tailored biologic therapy for acute asthma. Teva Respiratory works to extend, improve, and draw upon its drug arsenal through research and clinical development in order to create a significant positive impact on people’s lives.

About Teva Pharmaceuticals Europe

Teva Pharmaceuticals Europe makes life-saving and life-improving medicines more accessible for millions of people around the world. The company has a focus on treatments for migraine, conditions of the central nervous system including pain, as well as respiratory conditions like asthma and COPD and have a portfolio in oncology. Teva’s mission is to be a global leader in generics and biopharmaceuticals improving the lives of patients around the globe.

Headquartered in Israel, with production and research facilities around the globe, we employ 40,000 professionals, committed to improving the lives of millions of patients. Building on more than a century-old legacy Teva has an established presence in generics, specialty, over-the-counter (OTC) and active pharmaceutical ingredients (API). With a fully integrated R&D function, strong operational base and global infrastructure and scale the company invests millions of dollars to help its scientists find the next breakthrough.

Learn more at www.tevapharm.com.


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