Investigation assessing the publicly available evidence supporting postmarketing withdrawals, revocations and suspensions of marketing authorisations in the EU since 2012.
| Author | |
|---|---|
| Abstract | :
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 regulatory decisions. |
| Year of Publication | :
2018
|
| Journal | :
BMJ open
|
| Volume | :
8
|
| Issue | :
1
|
| Number of Pages | :
e019759
|
| Date Published | :
2018
|
| URL | :
http://bmjopen.bmj.com/cgi/pmidlookup?view=long&pmid=29362275
|
| DOI | :
10.1136/bmjopen-2017-019759
|
| Short Title | :
BMJ Open
|
| Download citation |