Study title: A Phase 1111 Study of the Safety. Tolerance and Pharmacokinetics ofMEDI-493. a Humanized Monoclonal Antibody to Respiratory Syncytial Virus. Administered Intramuscularly in Children with a History of Prematurity or Bronchopulmonary Dysplasia
Type of medicine: Centrally authorised medicines | |||||
Therapeutic area: Virus Diseases | |||||
Brands: Please see report, Please see report | |||||
MAH holders: Please see report, Please see report, Please see report, Please see report | |||||
Assessment: | |||||
Active substance: palivizumab | |||||
ATC code: | |||||
Document link: palivizumab-mi-cp012.pdf | |||||
Document date: 2013-07-25 | |||||
Study number: Mi-cp012 | |||||
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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