Study title: Multicentre, within patient controlled trial to assess the efficacy of the contrast agent MultiHance, at a dose of 0.1 mmol/kg in MRI of the CNS in paediatric patients.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Diagnosis | |||||
Brands: Please see report, Please see report, Please see report, Please see report, Please see report, Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: GADOBENIC ACID | |||||
ATC code: V08CA08 | |||||
Document link: EUdraCT-datafields for publication-Bracco-MultiHanceMH110.xls | |||||
Document date: 2011-09-29 | |||||
Study number: MH-110 | |||||
EudraCT number: 2005-004170... | |||||
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 |