THE European Medicines Agency
has embarked on a new level of
transparency by publishing
information on ongoing applications
for extensions of indication of
human medicines in the minutes of
the Pharmacovigilance Risk
Assessment Committee (PRAC).
This new transparency involves
the publication of information on
applications for changes to the
authorised use of medicines where
a change to the risk-management
plan (RMP) is needed.
The minutes from the PRAC's
most recent meeting (1-3 October
2012), include info on applications
for extensions of the indications for
the medicines Simponi, Onglyza
and Komboglyze.
Read the minutes at- ema.europa.eu.The above article was sent to subscribers in Pharmacy Daily's issue from 09 Nov 12 To see the full newsletter, see the embedded issue below or CLICK HERE to download Pharmacy Daily from 09 Nov 12
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