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| |  European Union Approves Nasonex Nasal Spray For Kids With Allergies MADISON, N.J. -- November 4 -- Schering-Plough’s Nasonex® (mometasone furoate monohydrate) Aqueous Nasal Spray has been approved in the European Union (EU) through the Mutual Recognition Procedure for use in children six to 11 years of age in the once-daily treatment of symptoms of seasonal allergic or perennial allergic rhinitis. The approval will result in individual marketing authorizations in the 13 European Union-Member States that participated in the Mutual Recognition Procedure, with the United Kingdom as the reference member state. Marketing authorization for this indication is also being sought in France and Sweden. Nasonex Aqueous Nasal Spray had previously been approved in the United States and in all 15 EU countries for the treatment of nasal symptoms of seasonal and/or perennial rhinitis in adults and children 12 years of age and older. "We are pleased with the approval through the Mutual Recognition Procedure of Nasonex in patients 6 to 11 years of age," said Hans-Jorg Kummer, president Europe/Canada, Schering-Plough Pharmaceuticals. "Physicians in European Union countries now have another therapeutic option for treating allergy in this important patient population." The approval was supported by clinical studies that assessed the activity and tolerance of Nasonex in over 1,000 pediatric patients. The EU product labeling notes that, in a placebo-controlled clinical trial in which pediatric patients were administered Nasonex 100 micrograms daily for one year, no reduction in growth was observed. In another study, 48 children aged 3 to 5 years were treated with Nasonex 50, 100 or 200 micrograms per day for 14 days. Results indicated no significant differences from placebo in the mean change in plasma cortisol level in response to the tetracosatrin stimulation test (low potential for systemic side effects). Nasonex Aqueous Nasal Spray is marketed in more than 35 countries worldwide, including major European countries, the United States and Canada. Mometasone furoate monohydrate is an anti-inflammatory corticosteroid discovered and developed by Schering-Plough Research Institute, the pharmaceutical research and development arm of Schering-Plough Corporation. In clinical trials, using the recommended dose, adverse events reported were headache, viral infection, pharyngitis, epistaxis (blood-tinged mucous) and coughing.
Related Links: Nasonex® and Schering-Plough.
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