Study title: A randomized, open label, parallel, single dose study of the antipyretic efficacy, safety, and blood levels of ibuprofen 6 mg/kg in febrile children with acetaminophen 10-15 mg/kg as a positive control for efficacy. CSR 106. Protocol 86-642, Unpublished Report 232.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Pathological Conditions, Signs and Symptoms | |||||
Brands: | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: IBUPROFEN AND PARACETAMOL | |||||
ATC code: | |||||
Document link: ibuprofen_paracetamol 86-642.pdf | |||||
Document date: 2011-09-27 | |||||
Study number: 86-642 | |||||
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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