Study title: Evaluate the safety of ampicillin suppositories with special emphasis on local intolerance reactions in pediatric patients. The secondary objective was to evaluate the short term efficiacy in the treatment of acute otitis media. The study was comparative against amoxycillin suspension.Bagger-Sjöbäck et al. (1986-11-28)
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Bacterial Infections and Mycoses | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: AMPICILLIN | |||||
ATC code: J01CA01 | |||||
Document link: EUdraCT_reduced datafields for Interim publication Recip_Ampicillin_19.xlsx | |||||
Document date: 2015-02-23 | |||||
Study number: | |||||
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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