Off-label use of medicines in children: can available evidence avoid useless paediatric trials?

Giovanni Tafuri (1, 2) , Francesco Trotta (2) , Hubert G. M. Leufkens (2, 3) , Nello Martini (2) , Luciano Sagliocca (4) , Giuseppe Traversa (2)

1 UIPS - Utrecht Institute for Pharmaceutical Sciences
2 Italian Medicines Agency (AIFA)
3 Medicines Evaluation Board (MEB)
4 Local Health Unit Salerno 1

Mots clés: Children; European Medicines Agency; Food and Drug Administration; Gastroesophageal reflux disease; Off-label; Proton pump inhibitors

Giovanni Tafuri, Francesco Trotta, Hubert G. M. Leufkens, Nello Martini, Luciano Sagliocca, et al.. Off-label use of medicines in children: can available evidence avoid useless paediatric trials?. European Journal of Clinical Pharmacology, 2008, 65 (2), pp.209-216. ⟨10.1007/s00228-008-0560-0⟩. ⟨hal-00477924⟩