Study title: An open phase III study of gadodiamide injection (Omniscan®) 0.1 mmol/kg b.w. used for MR examinations of the body (including the CNS) in children
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: SOV032 Redacted.pdf | |||||
Document date: 2011-09-30 | |||||
Study number: SOV032 | |||||
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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