Study title: Open Study to determine the concentration of telithromycin in middle ear fluid and plasma in infants/children with acute otitis media or otitis media with effusion after single oral administration of 20mg/kg or 30mg/kg 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/1004 | |||||
EudraCT number: | |||||
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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