Study title: The preoperative sedation of children.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Anesthesia and Analgesia [E03] | |||||
Brands: Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: HYDROXYZINE | |||||
ATC code: N05BB01 | |||||
Document link: ADRE92D1302.pdf | |||||
Document date: 2011-09-06 | |||||
Study number: ADRE92D1302 | |||||
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 | - |