Study title: Randomized study to investigate the effects on growth and the safety of the treatment with recombinant growth hormone in 1 to 2-year-old children with growth retardation due to chronic kidney failure
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Endocrine System Diseases [C19] | |||||
Brands: Please see report | |||||
MAH holders: Please see report, Please see report, Please see report | |||||
Assessment: | |||||
Active substance: Somatropin | |||||
ATC code: H01AC01 | |||||
Document link: GHCRF-E-2_Norditropin.pdf | |||||
Document date: 2011-09-22 | |||||
Study number: GHCRF/E/2 | |||||
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 | - | - |