Study title: AN OPEN-LABEL, MULTICENTER STUDY ASSESSING THE SAFETY AND TOLERANCE OF AN INTRAMUSCULARLY ADMINISTERED LOADING DOSE OF FOSPHENYTOIN IN PATIENTS REQUIRING A LOADING DOSE OF PHENYTOIN.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Nervous System Diseases [C10] | |||||
Brands: Please see report, Please see report, Please see report, Please see report | |||||
MAH holders: Please see report, Please see report | |||||
Assessment: | |||||
Active substance: FOSPHENYTOIN | |||||
ATC code: | |||||
Document link: EMA Pediatrics Web Synopsis.pdf | |||||
Document date: 2013-06-07 | |||||
Study number: 982-022 | |||||
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) |
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