GÖTEBORG, Sweden--(BUSINESS WIRE)-- Regulatory News: MEDA AB (publ)(STO:MEDAA) Dymista has received medical approval in Europe via the decentralized registration procedure. Dymista is approved for the treatment of seasonal and perennial allergic rhinitis. National registration processes, including negotiations regarding pricing and reimbursement, will now follow in each country prior to launch. Launches are anticipated in 2013 in several countries.
"Patients in Europe that suffer from allergic rhinitis will soon have access to a better treatment option than the current standard therapy. The faster and more complete effect offers significant benefit to the growing numbers of patients suffering from this difficult and inhibiting disease", said Anders Lönner, CEO of Meda AB.
Dymista is a novel nasal formulation of azelastine and fluticasone. The efficacy and safety of Dymista has been documented in several studies with more than 4,000 patients, including a long-term safety study with more than 600 patients. Dymista has consistently showed faster and more complete symptom relief than standard treatment. Dymista has been available in the US since September 2012.
MEDA AB (publ) is a leading international specialty pharma company. Meda’s products are sold in 120 countries worldwide and the company is represented by its own organizations in 50 countries. The Meda share is listed under Large Cap on the Nasdaq OMX Nordic Stock Exchange in Stockholm. Find out more, visit www.meda.se.
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