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valent, adsorbed) -<br />
EMEA/H/C/001104/II/0146<br />
MAH: Pfizer Limited, Rapporteur: Kristina<br />
Dunder, “Update of the SmPC section 4.5 to<br />
include information on Prevenar 13 coadministration<br />
with the tetanus toxoid<br />
conjugated meningococcal polysaccharide<br />
serogroups A, C, W and Y vaccine based on the<br />
results of study MenACWY-TT-104. Minor<br />
editorial changes have been introduced<br />
throughout the PI. Additionally the MAH took<br />
the opportunity to align the PI with the latest<br />
QRD template version 10.0.”<br />
Opinion adopted on 17.11.2016.<br />
Ranexa - ranolazine -<br />
EMEA/H/C/000805/II/0051<br />
MAH: Menarini International Operations<br />
Luxembourg S.A., Rapporteur: Kristina Dunder,<br />
“Update of section 5.1 of the SmPC in order to<br />
include the data from the final CSR of study<br />
RIVER-PCI. In addition, the Marketing<br />
authorisation holder (MAH) took the opportunity<br />
to update the details of local representative in<br />
Bulgaria in the Package Leaflet and to bring the<br />
Annex II in line with the latest QRD template<br />
version 9.1.”<br />
Request for Supplementary Information adopted<br />
on 21.07.2016, 14.04.2016.<br />
Rapamune - sirolimus -<br />
EMEA/H/C/000273/II/0163/G<br />
MAH: Pfizer Limited, Rapporteur: Kristina<br />
Dunder, “Update of section 4.4 of the SmPC to<br />
update the current warning on angioedema to<br />
include a possible dose-dependent effect<br />
between sirolimus and angioedema based on<br />
post-marketing data. Update of section 4.8 of<br />
the SmPC to include neuroendocrine carcinoma<br />
of the skin and malignant carcinoma as new<br />
ADRs and to include squamous cell carcinoma of<br />
the skin and basal cell carcinoma as part of the<br />
ADR ‘skin cancer’ based on post-marketing<br />
data. The Package Leaflet is updated<br />
accordingly. In addition, the Marketing<br />
authorisation holder (MAH) took the opportunity<br />
to combine the 0.5 mg, 1 mg and 2 mg tablets<br />
SmPC, to fully detail all components of the<br />
Rapamune printing ink in section 6.1 of the<br />
SmPC and in the Package Leaflet, to align the<br />
wording in section 4 of the Package Leaflet with<br />
section 4.8 of the SmPC regarding Clostridium<br />
Members were in agreement with the CHMP<br />
recommendation.<br />
Weekly start timetable.<br />
Weekly start timetable. The Committee<br />
adopted a Request for Supplementary<br />
information together with a specific timetable.<br />
Annex to December 2016 CHMP Agenda<br />
EMA/CHMP/819197/2016 Page 20/55
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