Study title: Evaluation of pharmacokinetics, safety, efficacy and acceptability of HMR3647 (20mg/kg and 30mg/kg q.d.) in pediatric patients with infection (a non-blind, randomised, parallel-group 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: HMR 3647B/2101 | |||||
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) |
- | - | - | - | - |