Study title: Open label, single arm, multicentric Phase IV
Type of medicine: Centrally authorised medicines | |||||
Therapeutic area: Pathological Conditions, Signs and Symptoms | |||||
Brands: | |||||
MAH holders: | |||||
Assessment: | |||||
Active substance: rasburicase | |||||
ATC code: V03AF07 | |||||
Document link: | |||||
Document date: 2011-09-22 | |||||
Study number: L8588 | |||||
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 |