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EMEA/H/W/002495/WS0922/0059/G<br />
Hexyon-<br />
EMEA/H/C/002796/WS0922/0055/G<br />
MAH: Sanofi Pasteur SA, Lead Rapporteur: Jan<br />
Mueller-Berghaus<br />
Request for Supplementary Information adopted<br />
on 13.10.2016.<br />
WS0969<br />
Infanrix hexa-<br />
EMEA/H/C/000296/WS0969/0204<br />
MAH: GSK Biologicals SA, Lead Rapporteur: Bart<br />
Van der Schueren<br />
Opinion adopted on 24.11.2016.<br />
Request for Supplementary Information adopted<br />
on 13.10.2016.<br />
Positive Opinion adopted by consensus on<br />
24.11.2016. The Icelandic and Norwegian CHMP<br />
Members were in agreement with the CHMP<br />
recommendation.<br />
WS0976/G<br />
Infanrix hexa-<br />
EMEA/H/C/000296/WS0976/0205/G<br />
MAH: GSK Biologicals SA, Lead Rapporteur: Bart<br />
Van der Schueren<br />
Request for Supplementary Information adopted<br />
on 13.10.2016.<br />
WS1003<br />
HyQvia-EMEA/H/C/002491/WS1003/0031<br />
Kiovig-EMEA/H/C/000628/WS1003/0075<br />
MAH: Baxter AG, Lead Rapporteur: Jan Mueller-<br />
Berghaus<br />
WS1043/G<br />
Helixate NexGen-<br />
EMEA/H/C/000276/WS1043/0182/G<br />
KOGENATE Bayer-<br />
EMEA/H/C/000275/WS1043/0189/G<br />
MAH: Bayer Pharma AG, Lead Rapporteur: Jan<br />
Mueller-Berghaus<br />
Request for Supplementary Information adopted<br />
on 24.11.2016.<br />
Weekly start timetable. The Committee<br />
adopted a Request for Supplementary<br />
information together with a specific timetable.<br />
WS1061/G<br />
Humalog-<br />
EMEA/H/C/000088/WS1061/0151/G<br />
Liprolog-<br />
EMEA/H/C/000393/WS1061/0115/G<br />
MAH: Eli Lilly Nederland B.V., Lead Rapporteur:<br />
Robert James Hemmings<br />
B.5.2. CHMP assessed procedures scope: Non-Clinical and Clinical aspects<br />
Arzerra - ofatumumab -<br />
EMEA/H/C/001131/II/0048, Orphan<br />
Annex to December 2016 CHMP Agenda<br />
EMA/CHMP/819197/2016 Page 14/55
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