Classification of Recombinant Biologics in the EU: Divergence Between National Pharmacovigilance Centers

BACKGROUND AND OBJECTIVE: Biological medicinal products (biologics) are subject to specific pharmacovigilance requirements to ensure that biologics are identifiable by brand name and batch number in adverse drug reaction (ADR) reports. Since Member States collect ADR data at the national level befor...

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Detalles Bibliográficos
Autores principales: Klein, Kevin, De Bruin, Marie L., Broekmans, Andre W., Stolk, Pieter
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2015
Materias:
Short Communication
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4684580/
https://www.ncbi.nlm.nih.gov/pubmed/26621793
http://dx.doi.org/10.1007/s40259-015-0149-y

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4684580/
https://www.ncbi.nlm.nih.gov/pubmed/26621793
http://dx.doi.org/10.1007/s40259-015-0149-y

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