Committee for medicinal products for human use (CHMP)
2eO29eq
2eO29eq
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MAH: Biogen Idec Ltd, Rapporteur: Jan<br />
Mueller-Berghaus, PRAC Rapporteur: Brigitte<br />
Keller-Stanislawski, “Update of section sections<br />
4.2, 4.3, 4.8, 5.1 and 5.2 of the SmPC based on<br />
the results of paediatric studies 101MS028 and<br />
101MS328, in accordance with<br />
paediatric investigation plan<br />
(EMEA-001095-PIP-12). An updated RMP version<br />
21 was provided as part of the application.”<br />
Request <strong>for</strong> Supplementary In<strong>for</strong>mation adopted<br />
on 15.09.2016, 23.06.2016.<br />
Tyverb - lapatinib -<br />
EMEA/H/C/000795/II/0048/G<br />
MAH: Novartis Europharm Ltd, Rapporteur: Filip<br />
Josephson, PRAC Rapporteur: Ulla Wändel<br />
Liminga“1) C.I.4 (type II): Update of sections<br />
4.4, 4.8, and 5.1 of the SmPC in order to add a<br />
warning on QTc prolongation and update safety<br />
in<strong>for</strong>mation following the submission of study<br />
report EGF114271 (A Phase IV placebo controlled<br />
single sequence crossover study to evaluate the<br />
effect of repeat oral doses of lapatinib on cardiac<br />
repolarization in patients with advanced cancer).<br />
The Package Leaflet is updated accordingly.<br />
2) C.I.4 (type II): Update of section 4.8 of the<br />
SmPC in order to further elaborate on the<br />
undesirable effect ‘serious cutaneous reactions’<br />
based on the review of the Novartis safety<br />
database. The Package Leaflet is updated<br />
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 10.<br />
Moreover, the MAH took the opportunity to<br />
update Annex II to delete an Annex II condition<br />
which has been fulfilled with procedure ANX.<br />
28.2.<br />
The RMP (version 32) is updated accordingly to<br />
the scopes presented above and also to introduce<br />
template-related changes, study milestones<br />
updates, and to upgrade ‘food effect’ to an<br />
important identified risk (from procedure<br />
EMEA/H/C/000795/II/0024).”<br />
Vectibix - panitumumab -<br />
EMEA/H/C/000741/II/0079<br />
MAH: Amgen Europe B.V., Rapporteur: Robert<br />
James Hemmings, PRAC Rapporteur: Julie<br />
Williams, “Update of section 4.6 of the SmPC in<br />
order to remove the references to the Pregnancy<br />
Surveillance Program (PSP) and Lactation<br />
Annex to November 2016 <strong>CHMP</strong> Agenda<br />
EMA/<strong>CHMP</strong>/682759/2016 Page 30/43
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