Study title: A comparison of the efficacy and safety of ibuprofen suspension dosed at 5 mg/kg and 10 mg/kg and acetaminophen elixir dosed at 12.5 mg/kg to placebo in children with ear pain. CSR 161. Protocol 90-002, 90-003, Unpublished Report 287.
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Otorhinolaryngologic Diseases | |||||
Brands: | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: IBUPROFEN AND PARACETAMOL | |||||
ATC code: | |||||
Document link: ibuprofen_paracetamol 90-002_3.pdf | |||||
Document date: 2011-09-27 | |||||
Study number: 90-002_3 | |||||
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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