Study title: Evaluation of the Safety, Pharmacokinetics, Efficacy and Acceptability of HMR 3647 20mg/kg QD for 5-7 Days with Community Acquired Pneumonia (CAP) in children. (Multicenter, open label, non comparative study)
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 | |||||
Document link: | |||||
Document date: | |||||
Study number: HMR3647B/3101 | |||||
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) |
- | - | - | - | - |