Study title: Open label study of Gadopentetate Dimeglumine as a magnetic resonance imaging (MRI) contrast agent in pediatric patients presenting with symptoms of central nervous system (CNS) lesions.
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_88492_study_synopsis.pdf | |||||
Document date: 2011-09-07 | |||||
Study number: 88492 | |||||
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 |