Committee for medicinal products for human use (CHMP)

Kalydeco - ivacaftor -
EMEA/H/C/002494/II/0049, Orphan
MAH: Vertex Pharmaceuticals (Europe) Ltd.,
Rapporteur: Concepcion Prieto Yerro, PRAC
Rapporteur: Dolores Montero Corominas,
“Submission of the final Clinical Study Report
(CSR) for Study VX11-770-109 (Study 109) to
fulfil the RMP commitment to address the
following safety concerns: hepatotoxicity,
cataracts, cardiac arrhythmias, use in children
between 2 to 5 years old, long-term safety. An
updated RMP (v5.1 updated from v4.9) is
included in this submission to include the final
data from Study 109.”
Request for Supplementary Information adopted
on 15.09.2016.
Kyprolis - carfilzomib -
EMEA/H/C/003790/II/0007/G, Orphan
MAH: Amgen Europe B.V., Rapporteur: Aranzazu
Sancho-Lopez, PRAC Rapporteur: Nikica
Mirošević Skvrce “Update of sections 4.2 and 5.2
of the SmPC to revise the guidance on use in
patients with renal and hepatic impairment with
the submission of studies relating to renal
impairment (CFZ001) and hepatic impairment
(CFZ002).
In addition, the Marketing Authorisation Holder
(MAH) took the opportunity to make editorial
changes to the Product information, which
includes a correction of a typographical omission
in section 4.4 to align the statement on sodium
content with that in section 2 and the package
leaflet by specifying levels given are per mL of
reconstituted product.
The RMP has been updated accordingly.”
Request for Supplementary Information adopted
on 15.09.2016.
Levetiracetam Hospira - levetiracetam -
EMEA/H/C/002783/II/0012
MAH: Hospira UK Limited, Generic, Generic of
Keppra, Rapporteur: Juris Pokrotnieks, PRAC
Rapporteur: Laurence de Fays, “Update the
product information (SmPC and PIL) for
Levetiracetam in line with company core safety
information (CSI) version 1.0.
A signal detection finding was included in the
Levetiracetam CSI, to include an adverse effect
Rhabdomyolysis & Blood creatine phosphokinase
increased. Subsequently, the SmPC and PIL have
been updated with this new information.”
Annex to November 2016 CHMP Agenda
EMA/CHMP/682759/2016 Page 25/43