Effect of safety issues with HIV drugs on the approval process of other drugs in the same class: an analysis of European Public Assessment Reports.

Background: Knowledge on the safety of new medicines is limited at the time of market entry. Nearly half of all drugs used to treat HIV registered in the EU required ≥1 Direct Healthcare Professional Communication (DHPC) in the past 10 years for safety issues identified post-approval.Objective: The...

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Publicado en:	Drug Safety Vol. 34; no. 11; pp. 1101 - 1115
Autores principales:	Arnardottir AH, Haaijer-Ruskamp FM, Straus SM, de Graeff PA, Mol PG, Arnardottir, Arna H, Haaijer-Ruskamp, Flora M, Straus, Sabine M J, de Graeff, Pieter A, Mol, Peter G M
Formato:	research Journal Article
Publicado:	Springer Nature 2011
Acceso en línea:	Ver este registro en EBSCOhost