Study title: Open, uncontrolled study on the safety and efficacy of Gd-DTPA (SH L 451 AA) in magnetic resonance imaging of musculo-skeletal lesions in children and teenage patients, 16-18 years (phase III)
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Diagnosis [E01] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: GADOPENTETIC ACID | |||||
ATC code: | |||||
Document link: Bayer Pharma_Gadopentetate Dimeglumine_87191_study_synopsis.pdf | |||||
Document date: 2011-09-07 | |||||
Study number: 87191 | |||||
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 |