Study title: NDA 20-073 (USA) Romazicon ® (flumazenil) injection, S-008 NDA 20-073 (USA) Pediatric labelling supplement December 12,1996
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Nervous System Diseases | |||||
Brands: Please see report, Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: FLUMAZENIL | |||||
ATC code: V03AB25 | |||||
Document link: | |||||
Document date: | |||||
Study number: | |||||
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 |