Traceability of Biologics in The Netherlands: An Analysis of Information-Recording Systems in Clinical Practice and Spontaneous ADR Reports

INTRODUCTION AND OBJECTIVE: Pharmacovigilance requirements for biologics mandate that EU Member States shall ensure that any biologic that is the subject of a suspected adverse drug reaction (ADR) is identifiable by brand name and batch number. Recent studies showed that brand name identification is...

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Detalhes bibliográficos
Publicado no:Drug Saf
Main Authors: Klein, Kevin, Scholl, Joep H. G., Vermeer, Niels S., Broekmans, André W., Van Puijenbroek, Eugène P., De Bruin, Marie L., Stolk, Pieter
Formato: Artigo
Idioma:Inglês
Publicado em: Springer International Publishing 2015
Assuntos:
Original Research Article
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC4735237/
https://ncbi.nlm.nih.gov/pubmed/26719190
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s40264-015-0383-8
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