Study title: Open Study to determine the concentration of telithromycin in the extracellular and intracellular compartments of middle ear fluid in children with acute otitis media or otitis media with spontaneous effusion after single oral administration of a telithromycin pediatric suspension
Type of medicine: Centrally authorised medicines | |||||
Therapeutic area: Bacterial Infections and Mycoses | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: telithromycin | |||||
ATC code: J01FA15 | |||||
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Document date: | |||||
Study number: HMR 3647B/1007 | |||||
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Scope of study: CLINICAL | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
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