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Labeling of Enalapril from Neonates up to Adolescents (LENA)

Date du début: 1 nov. 2013, Date de fin: 31 oct. 2018,

Children are often treated as small adults—not as the special patients they are. Regulations exist to encourage the development of drugs and formulation for children. However, off-patent drugs are often administered to children without appropriate formulations or systematic investigations. Therefore, the paediatric use marketing authorisation (PUMA) has been designed.The EMA Paediatric Working Par ...
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