Study title:
A phase III, double-blind, parallel-group, randomized, comparative, two-centre study on gadodiamide injection (Omniscan) and Magnevist® at 0.1 mmol/kg b.w. in MR examinations of the CNS in children and adolescents in a 0.5 T Philips Gyroscan MR unit at the University Hospital Eppendorf, Hamburg, Germany, and in a 1.5T Philips Gyroscan S15 MR unit at the Department of Diagnostic Radiology, University of Cologne, Cologne, Germany
Type of medicine: Medicines containing chemical active substances
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Therapeutic area: Diagnosis
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Brands: Please see report, Please see report |
MAH holders: Please see report |
Assessment: |
Active substance: GADODIAMIDE |
ATC code: |
Document link:
SOV033 Redacted.pdf
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Document date: 2011-09-30
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Study number: SOV033 |
EudraCT number:
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Scope of study: CLINICAL |
Population of study subjects:
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Preterm newborn Infants
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Newborn infants
(1 to 27 days)
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Infants and toddlers
(28 days to 24 months)
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Children
(2 to 11 years)
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Adolescents
(12 to 18 years)
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