Committee for medicinal products for human use (CHMP)
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ased on <strong>use</strong>r testing results. The Package<br />
Leaflet is updated accordingly.<br />
In addition, the Marketing authorisation holder<br />
(MAH) took the opportunity to bring the PI in line<br />
with the latest QRD template version 9.1, to<br />
include some corrections, to align the wording<br />
across combined hepatitis A and B vaccines (i.e.<br />
Twinrix Adult, Twinrix Paediatric and Ambirix)<br />
and to combine the SmPC of the vial and<br />
pre-filled syringe presentations.”<br />
Request <strong>for</strong> Supplementary In<strong>for</strong>mation adopted<br />
on 21.07.2016.<br />
Vokanamet - canagliflozin / met<strong>for</strong>min -<br />
EMEA/H/C/002656/II/0016<br />
MAH: Janssen-Cilag International N.V.,<br />
Rapporteur: Martina Weise, PRAC Rapporteur:<br />
Menno van der Elst, “Submission of a revise RMP<br />
in order to update the following in<strong>for</strong>mation:<br />
Article 20 procedure on DKA including updates to<br />
reflect discussions with PRAC on renal<br />
impairment/renal failure; hypersensitivity and<br />
DKA, update the in<strong>for</strong>mation related to revisions<br />
to proposed dates <strong>for</strong> completion of clinical<br />
studies and to include additional studies<br />
requested as part of the Article 20 DKA review<br />
procedure.”<br />
Request <strong>for</strong> Supplementary In<strong>for</strong>mation adopted<br />
on 15.09.2016.<br />
Votrient - pazopanib -<br />
EMEA/H/C/001141/II/0039<br />
MAH: Novartis Europharm Ltd, Rapporteur: Sinan<br />
B. Sarac, “Update of section 4.8 to add the<br />
adverse reaction Polycythaemia. This variation,<br />
based on cumulative review of all cases, is<br />
provided following the PRAC request on the signal<br />
assessment report EPITT no 18660. The Package<br />
Leaflet is updated accordingly.”<br />
Xeplion - paliperidone -<br />
EMEA/H/C/002105/II/0030<br />
MAH: Janssen-Cilag International N.V.,<br />
Rapporteur: Kristina Dunder, “Update of section<br />
4.8 of the SmPC in order to update the safety<br />
in<strong>for</strong>mation after assessment of study<br />
R092670-SCA-3004. The Package Leaflet is<br />
updated accordingly. In addition, the Marketing<br />
authorisation holder (MAH) took the opportunity<br />
to Align the Product in<strong>for</strong>mation of Xeplion with<br />
safety updates implemented <strong>for</strong> TREVICTA<br />
Product In<strong>for</strong>mation (<strong>for</strong> which XEPLION is the<br />
Weekly start timetable.<br />
Weekly start timetable.<br />
Annex to November 2016 <strong>CHMP</strong> Agenda<br />
EMA/<strong>CHMP</strong>/682759/2016 Page 17/43
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