Study title: Open, non-comparative study in angiocardiography in children, Angiocardiography: evaluate safety, tolerance and the radiographic properties of of iohexol in pediatric use. Systolic blood pressure, ECG parameters, body temperature, visualization and adverse reactions were recorded.Applicant's study report
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: IOHEXOL | |||||
ATC code: V08AB02 | |||||
Document link: Copy of List of studies Omnipaque- pediatric.xls | |||||
Document date: 2015-01-23 | |||||
Study number: Iohexol No. 32 | |||||
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) |
- | - | Y | Y | Y |