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In addition, the Marketing authorisation holder<br />
(MAH) took the opportunity to bring the PI in<br />
line with the latest QRD template version.”<br />
Request for Supplementary Information adopted<br />
on 21.07.2016.<br />
Tecfidera - dimethyl fumarate -<br />
EMEA/H/C/002601/II/0034<br />
MAH: Biogen Idec Ltd, Rapporteur: Martina<br />
Weise, “To update Section 5.3 (Preclinical<br />
Safety Data) of the Summary of Product<br />
Characteristics (SmPC) to reflect that exposure<br />
margins have been re-calculated based on the<br />
area under the concentration-time curve (AUC)<br />
rather than based on body surface area<br />
(mg/m2).”<br />
Opinion adopted on 17.11.2016.<br />
Positive Opinion adopted by consensus on<br />
17.11.2016. The Icelandic and Norwegian CHMP<br />
Members were in agreement with the CHMP<br />
recommendation.<br />
Viekirax - ombitasvir / paritaprevir /<br />
ritonavir - EMEA/H/C/003839/II/0025<br />
MAH: AbbVie Ltd., Rapporteur: Filip Josephson,<br />
“Update of sections 4.3 and 4.5 of the SmPC to<br />
add three additional contraindication<br />
medications with dronedarone, lurasidone and<br />
ranolazine. The Package Leaflet is updated<br />
accordingly.”<br />
Vimpat - lacosamide -<br />
EMEA/H/C/000863/II/0066/G<br />
MAH: UCB Pharma S.A., Rapporteur: Filip<br />
Josephson, “Update of section 4.2 of the SmPC<br />
in order to update the safety information<br />
regarding the use of lacosamide in patients with<br />
hepatic impairment, section 4.8 to add a new<br />
adverse drug reaction (hepatic enzyme<br />
increased (> 2x ULN)) and section 4.9 regarding<br />
lacosamide overdose based on postmarketing<br />
reports. The Package Leaflet is updated<br />
accordingly.<br />
In addition, the Marketing authorisation holder<br />
(MAH) took the opportunity to update the list of<br />
local representatives in the Package Leaflet and<br />
to make minor editorial change in the SmPC.”<br />
Zydelig - idelalisib -<br />
EMEA/H/C/003843/II/0029<br />
MAH: Gilead Sciences International Ltd,<br />
Rapporteur: Filip Josephson, “Submission of the<br />
final study report for the clinical study 101-07<br />
"A Phase I Study To Investigate the Safety and<br />
Clinical Activity of Idelalisib in Combination with<br />
Chemotherapeutic Agents, Immunomodulatory<br />
Agents and Anti-CD-20 mAb in Subjects with<br />
Weekly start timetable.<br />
Annex to December 2016 CHMP Agenda<br />
EMA/CHMP/819197/2016 Page 23/55
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