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Variation in adverse drug reactions listed in product information for antidepressants and anticonvulsants, between the USA and Europe: a comparison review of paired regulatory documents

OBJECTIVE: To compare consistency of adverse drug reaction (ADR) data in publicly available product information documents for brand drugs, between the USA and Europe. To assess the usefulness of information for prescribers and patients. DESIGN: A comparison review of product information documents fo...

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Detalles Bibliográficos
Autores principales: Cornelius, Victoria R, Liu, Kun, Peacock, Janet, Sauzet, Odile
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2016
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4800139/
https://www.ncbi.nlm.nih.gov/pubmed/26996819
http://dx.doi.org/10.1136/bmjopen-2015-010599