Study title: Demonstration of the Analgesic Efficacy and Safety of Liquid Formulations of Ibuprofen (10mg/kg), Acetaminophen (15mg/kg), and Placebo in the relief of Orthodontic Pain in Children
Type of medicine: Medicines containing chemical active substances | |||||
Therapeutic area: Anesthesia and Analgesia | |||||
Brands: Please see report, Please see report | |||||
MAH holders: Please see report, Please see report, Please see report | |||||
Assessment: | |||||
Active substance: PARACETAMOL | |||||
ATC code: NO2BE01 | |||||
Document link: Paracetamol Clinical Trial Summaries.pdf | |||||
Document date: 2013-07-25 | |||||
Study number: WM-390 | |||||
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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