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| | | ![]() Grass Pollens Desensitisation Tablets Approved in Germany for Paediatric Use NEW YORK -- January 20, 2009 -- The Paul Ehrlich Institute has approved an additional indication for Oralair Grasses sublingual tablets to include desensitisation to grass pollens in children. The approval is based on results from the phase 3 paediatric trial, VO 52.06, conducted in 278 allergic rhinoconjunctivitis-sufferers aged between 5 and 17 years in 5 European countries (Denmark, France, Germany, Poland, and Spain). The study confirmed the results of the adult trial: an excellent tolerance profile and a statistically and clinically significant reduction in symptoms. The paediatric and adult dosages are identical. The drug has been shown to be effective in rhinoconjunctivitis caused by allergy to grass pollens from the first season, throughout the entire pollen season and during pollen peaks in poly- and mono-sensitised patients and asthmatic patients, and on every individual symptom, and on nasal congestion and watery eyes. SOURCE: Stallergenes
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