Articles with "marketing authorisations" as a keyword



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

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Published in 2018 at "BMJ Open"

DOI: 10.1136/bmjopen-2017-019759

Abstract: 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… read more here.

Keywords: marketing authorisations; evidence supporting; since 2012; publicly available ... See more keywords