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EMEA/H/C/004264/II/0005/G<br />
MAH: Techdow Europe AB, Duplicate, Duplicate<br />
of Thorinane, Rapporteur: Andrea Laslop<br />
Kanuma - sebelipase alfa -<br />
EMEA/H/C/004004/II/0006/G, Orphan<br />
MAH: Alexion Europe SAS, Rapporteur: Bart Van<br />
der Schueren<br />
Request for Supplementary Information adopted<br />
on 10.11.2016.<br />
Lantus - insulin glargine -<br />
EMEA/H/C/000284/II/0107/G<br />
MAH: Sanofi-aventis Deutschland GmbH,<br />
Rapporteur: Johann Lodewijk Hillege<br />
Nimenrix - meningococcal group A, C,<br />
W135 and Y conjugate vaccine -<br />
EMEA/H/C/002226/II/0062<br />
MAH: Pfizer Limited, Rapporteur: Greg Markey<br />
Opinion adopted on 09.02.2017.<br />
Weekly start timetable.<br />
Positive Opinion adopted by consensus on<br />
09.02.2017. The Icelandic and Norwegian CHMP<br />
Members were in agreement with the CHMP<br />
recommendation.<br />
Onivyde - irinotecan hydrochloride<br />
trihydrate - EMEA/H/C/004125/II/0002,<br />
Orphan<br />
MAH: Baxalta Innovations GmbH, Rapporteur:<br />
Filip Josephson<br />
OPDIVO - nivolumab -<br />
EMEA/H/C/003985/II/0022/G<br />
MAH: Bristol-Myers Squibb Pharma EEIG,<br />
Rapporteur: Aranzazu Sancho-Lopez<br />
Opinion adopted on 02.02.2017.<br />
Request for Supplementary Information adopted<br />
on 01.12.2016.<br />
Orencia - abatacept -<br />
EMEA/H/C/000701/II/0106/G<br />
MAH: Bristol-Myers Squibb Pharma EEIG,<br />
Rapporteur: Outi Mäki-Ikola<br />
Request for Supplementary Information adopted<br />
on 02.02.2017.<br />
Pheburane - sodium phenylbutyrate -<br />
EMEA/H/C/002500/II/0014<br />
MAH: Lucane Pharma, Rapporteur: David Lyons<br />
Opinion adopted on 02.02.2017.<br />
Request for Supplementary Information adopted<br />
on 10.11.2016.<br />
Prevenar 13 - pneumococcal<br />
polysaccharide conjugate vaccine (13-<br />
valent, adsorbed) -<br />
EMEA/H/C/001104/II/0147/G<br />
Positive Opinion adopted by consensus on<br />
02.02.2017. The Icelandic and Norwegian CHMP<br />
Members were in agreement with the CHMP<br />
recommendation.<br />
Weekly start timetable. The Committee<br />
adopted a Request for Supplementary<br />
information together with a specific timetable.<br />
Positive Opinion adopted by consensus on<br />
02.02.2017. The Icelandic and Norwegian CHMP<br />
Members were in agreement with the CHMP<br />
recommendation.<br />
Positive Opinion adopted by consensus on<br />
02.02.2017. The Icelandic and Norwegian CHMP<br />
Members were in agreement with the CHMP<br />
recommendation.<br />
Annex to February 2017 CHMP Agenda<br />
EMA/CHMP/117606/2017 Page 11/66
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