Committee for medicinal products for human use (CHMP)
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Request <strong>for</strong> Supplementary In<strong>for</strong>mation adopted<br />
on 15.09.2016.<br />
Zaltrap - aflibercept -<br />
EMEA/H/C/002532/II/0025/G<br />
MAH: Sanofi-Aventis Groupe, Rapporteur: Filip<br />
Josephson<br />
Request <strong>for</strong> Supplementary In<strong>for</strong>mation adopted<br />
on 04.08.2016, 19.05.2016.<br />
WS0950<br />
Leganto-EMEA/H/C/002380/WS0950/002<br />
1<br />
Neupro-EMEA/H/C/000626/WS0950/0071<br />
MAH: UCB Manufacturing Ireland Ltd., Lead<br />
Rapporteur: Bruno Sepodes<br />
Request <strong>for</strong> Supplementary In<strong>for</strong>mation adopted<br />
on 04.08.2016.<br />
Weekly start timetable.<br />
Weekly start timetable.<br />
WS0954<br />
Filgrastim<br />
Hexal-EMEA/H/C/000918/WS0954/0033<br />
Zarzio-EMEA/H/C/000917/WS0954/0034<br />
MAH: SANDOZ GmbH, Lead Rapporteur: Greg<br />
Markey<br />
Hexacima-EMEA/H/C/002702/WS0964/00<br />
51/G<br />
Hexaxim-EMEA/H/W/002495/WS0964/00<br />
58/G<br />
Hexyon-EMEA/H/C/002796/WS0964/005<br />
4/G<br />
MAH: Sanofi Pasteur SA, Lead Rapporteur: Jan<br />
Mueller-Berghaus<br />
Request <strong>for</strong> Supplementary In<strong>for</strong>mation adopted<br />
on 15.09.2016.<br />
B.5.2. <strong>CHMP</strong> assessed procedures scope: Non-Clinical and Clinical aspects<br />
Ambirix - hepatitis A (inactivated) and<br />
hepatitis B(rDNA) (HAB) vaccine<br />
(adsorbed) - EMEA/H/C/000426/II/0077<br />
MAH: GSK Biologicals SA, Rapporteur: Robert<br />
James Hemmings, “Update of section 6.6 of the<br />
SmPC in order to update the re-suspension<br />
instructions, based on <strong>use</strong>r testing results. The<br />
Package Leaflet is updated 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 9.1, to<br />
include some corrections and to align the wording<br />
across combined hepatitis A and hepatitis B<br />
Annex to November 2016 <strong>CHMP</strong> Agenda<br />
EMA/<strong>CHMP</strong>/682759/2016 Page 11/43
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