Study title: An open, non-comparative, phase III study of gadodiamide injection (Omniscan®) 0.1 mmol/kg b.w. used for magnetic resonance examinations of the CNS in children from 6 months to 14 years of age in a 0.5 T Esaote MR unit
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Diagnosis | |||||
Brands: Please see report, Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: GADODIAMIDE | |||||
ATC code: | |||||
Document link: SOV031 Redacted.pdf | |||||
Document date: 2011-09-30 | |||||
Study number: SOV031 | |||||
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 |