Study title:
Multicenter, Phase II, open-label study of
the efficacy, safety, acceptability, and
pharmacokinetics of telithromycin,
following administration of 15mg/kg twice
daily, for 5 days in the treatment of acute
otitis media in children
Type of medicine: Centrally authorised medicines
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Therapeutic area: Bacterial Infections and Mycoses
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Brands: Please see report |
MAH holders: Please see report |
Assessment: |
Active substance: telithromycin |
ATC code: J01FA15 |
Document link:
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Document date:
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Study number: HMR
3647B/B2006 |
EudraCT number:
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Scope of study: CLINICAL |
Population of study subjects:
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Preterm newborn Infants
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Newborn infants
(1 to 27 days)
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Infants and toddlers
(28 days to 24 months)
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Children
(2 to 11 years)
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Adolescents
(12 to 18 years)
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