Study title: A phase III, randomised, double blind comparison of Iodixanol (VISIPAQUE; 270 mgI/mL and 320 mgI/mL) and OMNIPAQUE 300 (Iohexol) in pediatric patients requiring computed tomography (CT) scanning of the bodyStudy Report 1967 (Date Dec 1995)
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Diagnosis | |||||
Brands: Please see report, Please see report | |||||
MAH holders: Please see report, Please see report, Please see report | |||||
Assessment: | |||||
Active substance: IODIXANOL | |||||
ATC code: V08AB09 | |||||
Document link: Study Report 1967 Redacted.pdf | |||||
Document date: 2013-10-07 | |||||
Study number: 39998-012 | |||||
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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