Study title: Follow up on Infants Treated with Porcine Surfactant Replacement for Severe Neonatal and Infant Respiratory Distress Syndrome: Antigenic Reactivity Evaluation(Marraro G.)
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: PORACTANT ALFA | |||||
ATC code: | |||||
Document link: 50.01-CT-02-93 publication.pdf | |||||
Document date: 2015-03-02 | |||||
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) |
- | - | Y | Y | Y |