Committee for medicinal products for human use (CHMP)
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Surveillance Programs (LSP). The Package<br />
Leaflet is updated accordingly.<br />
The RMP was also submitted in order to remove<br />
references to PSP and LSP.<br />
In addition, the Marketing authorisation holder<br />
(MAH) took the opportunity to make further<br />
administrative updates to the RMP.”<br />
Vectibix - panitumumab -<br />
EMEA/H/C/000741/II/0080<br />
MAH: Amgen Europe B.V., Rapporteur: Robert<br />
James Hemmings, PRAC Rapporteur: Julie<br />
Williams, “Update of Annex II in order to provide<br />
the results of biomarker analyses from the<br />
Vectibix clinical programme including Study<br />
20080763 (according to Supplementary<br />
Statistical Analysis Plan dated 20 September<br />
2013), Study 20070820 and Study 20060447.<br />
The data submitted are in fulfilment of Annex II<br />
obligation ANX017.<br />
The Risk Management Plan (version 21.0) has<br />
been updated accordingly.<br />
The requested variation proposed amendments<br />
to Annex II and the Risk Management Plan.”<br />
Voncento - <strong>human</strong> coagulation factor VIII /<br />
<strong>human</strong> von willebrand factor -<br />
EMEA/H/C/002493/II/0017/G<br />
MAH: CSL Behring GmbH, Rapporteur: Paula<br />
Boudewina van Hennik, PRAC Rapporteur:<br />
Sabine Straus“C.I.4 (type II): Update of section<br />
4.8 of the SmPC in order to update the<br />
frequencies of undesirable effects to reflect the<br />
final clinical study data from study<br />
CSLCT-BIO-08-53 in haemophilia A paediatric<br />
patients. The Package Leaflet is updated<br />
accordingly. The submission of the final CSR<br />
CSLCT-BIO-08-53 also leads to changes to the<br />
RMP (ver. 6.1) in order update the Company Core<br />
Safety In<strong>for</strong>mation (CCSI).<br />
C.I.11.z (type IB): Submission of a revised RMP<br />
in order to remove the commitment to conduct a<br />
post-marketing study <strong>for</strong> haemophilia A patients<br />
(CSLCT-BIO-12-78) <strong>for</strong> Voncento as<br />
consequence of new data from study<br />
CSLCT-BIO-08-53.<br />
In addition, the Marketing authorisation holder<br />
(MAH) took the opportunity to combine different<br />
strengths in the SmPC and Package Leaflet.”<br />
Request <strong>for</strong> Supplementary In<strong>for</strong>mation adopted<br />
on 01.04.2016, 19.11.2015.<br />
Annex to November 2016 <strong>CHMP</strong> Agenda<br />
EMA/<strong>CHMP</strong>/682759/2016 Page 31/43
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