Investigation assessing the publicly available evidence supporting postmarketing withdrawals, revocations and suspensions of marketing authorisations in the EU since 2012

OBJECTIVES: To assess the sources of publicly available evidence supporting withdrawal, revocation or suspension of marketing authorisations (‘regulatory actions’) due to safety reasons in the EU since 2012 and to investigate the time taken since initial marketing authorisation to reach these regula...

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Detalles Bibliográficos
Autores principales: Lane, Samantha, Lynn, Elizabeth, Shakir, Saad
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BMJ Publishing Group 2018
Materias:
Pharmacology and Therapeutics
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5786078/
https://www.ncbi.nlm.nih.gov/pubmed/29362275
http://dx.doi.org/10.1136/bmjopen-2017-019759

Internet

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5786078/
https://www.ncbi.nlm.nih.gov/pubmed/29362275
http://dx.doi.org/10.1136/bmjopen-2017-019759

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