Study title: Contrast Enhanced Magnetic Resonance Imaging of the Central Nervous System in Patients Between 2 and 18 Years of Age by Intravenous Administration: A Randomized Double-Blind Comparison of Gadodiamide Injection (Gd DTPA BMA) 0.1 mmol/kg with MAGNEVIST® (Gd DTPA) 0.1 mmol/kg (Protocol 50678-005, Study B)
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: SW1358 Redacted.pdf | |||||
Document date: 2011-09-30 | |||||
Study number: SW1358 | |||||
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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