Committee for medicinal products for human use (CHMP)

to the existing ADR table footnote that indicates
that they originated from spontaneous
post-marketing reports.
2. C.I.4 – Update of section 4.4 to include
Hypertension as one of the risk factors for atrial
fibrillation/flutter.
The Package Leaflet is updated accordingly.
Updated version 6.2 of the RMP has been
submitted.”
Jetrea - ocriplasmin -
EMEA/H/C/002381/II/0026
MAH: ThromboGenics NV, Rapporteur: Greg
Markey, PRAC Rapporteur: Julie Williams,
“Update of sections 4.4, 4.8 and 5.1 of the SmPC
to reflect new long-term safety and efficacy data
based on the final CSR for study TG-MV-014 in
fulfilment of the post-authorisation measure MEA
002. The Package Leaflet has been updated
accordingly. In addition, the MAH took the
opportunity to implement editorial changes in the
annexes, to align the annexes with the latest QRD
templates (v9.1 and 10) and to update the
contact details of the local representative in
Spain in the Package Leaflet. An updated RMP
version 7 was included as part of the application.”
Request for Supplementary Information adopted
on 13.10.2016, 26.05.2016.
Jevtana - cabazitaxel -
EMEA/H/C/002018/II/0034
MAH: Sanofi-Aventis Groupe, Rapporteur: Pierre
Demolis, PRAC Rapporteur: Claire Ferard,
“Update of sections 4.2, 4.8 and 5.1 of the SmPC
in order to add information from completed study
EFC11785 (Randomized, open-label multicenter
study comparing cabazitaxel at 20 mg/m2 and at
25 mg/m2 every 3 weeks in combination with
prednisone for the treatment of metastatic
castration-resistant prostate cancer previously
treated with a docetaxel-containing regimen). In
addition, the MAH is proposing to modify the
wording in section 4.1 of the indication from
“hormone refractory” to “castration resistant”
prostate cancer to reflect current terminology of
the disease in the clinical practice. The RMP is
updated accordingly and in accordance with the
request from the latest PSUR procedure
(EMEA/C/H/002018/PSUSA/000476/201506)”
Request for Supplementary Information adopted
on 15.09.2016.
Annex to November 2016 CHMP Agenda
EMA/CHMP/682759/2016 Page 24/43