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 20.10.2016.<br />
WS1035/G<br />
Epclusa-EMEA/H/C/004210/WS1035/000<br />
2/G<br />
Harvoni-EMEA/H/C/003850/WS1035/003<br />
6/G<br />
Sovaldi-EMEA/H/C/002798/WS1035/0034<br />
/G<br />
MAH: Gilead Sciences International Ltd, Lead<br />
Rapporteur: Filip Josephson<br />
WS1036<br />
Helixate<br />
NexGen-EMEA/H/C/000276/WS1036/018<br />
1<br />
KOGENATE<br />
Bayer-EMEA/H/C/000275/WS1036/0188<br />
MAH: Bayer Pharma AG, Lead Rapporteur: Jan<br />
Mueller-Berghaus<br />
Weekly start timetable.<br />
Weekly start timetable.<br />
WS1054<br />
Humalog-EMEA/H/C/000088/WS1054/01<br />
49<br />
Liprolog-EMEA/H/C/000393/WS1054/011<br />
3<br />
MAH: Eli Lilly Nederland B.V., Lead Rapporteur:<br />
Robert James Hemmings, “To update sections 1,<br />
2.2, 4.2, 4.4, 5.1, 6.6 of the SmPC with minor<br />
amendments, e.g. to change “u/ml” to<br />
“units/ml”. The package leaflet and labelling were<br />
updated accordingly and minor editorial changes<br />
were also included in annex II.<br />
In addition a newly <strong>for</strong>matted <strong>use</strong>r manual <strong>for</strong><br />
insulin lispro KwikPen 100 units/ml was<br />
introduced. The new <strong>for</strong>mat aims to present the<br />
in<strong>for</strong>mation related to the operating the pen in a<br />
simpler manner and to reduce the repetition of<br />
in<strong>for</strong>mation as compared to the previous<br />
version.”<br />
B.5.9. In<strong>for</strong>mation on withdrawn type II variation / WS procedure<br />
B.5.10. In<strong>for</strong>mation on type II variation / WS procedure with revised timetable<br />
B.5.11. Worksharing variations according to Article 20 of Commission Regulation (EC) No<br />
1234/2008 (listing intended submissions of type II variations <strong>for</strong> CAPs and NAPS with the<br />
outcome regarding the Lead Rapporteur)<br />
Annex to November 2016 <strong>CHMP</strong> Agenda<br />
EMA/<strong>CHMP</strong>/682759/2016 Page 38/43
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