ongoing

on 17.11.2016, 12.05.2016, 03.03.2016.
Elocta - efmoroctocog alfa -
EMEA/H/C/003964/II/0008/G
MAH: Swedish Orphan Biovitrum AB (publ),
Rapporteur: Jan Mueller-Berghaus
Request for Supplementary Information adopted
on 13.10.2016.
Empliciti - elotuzumab -
EMEA/H/C/003967/II/0003
MAH: Bristol-Myers Squibb Pharma EEIG,
Rapporteur: Paula Boudewina van Hennik
Opinion adopted on 24.11.2016.
Request for Supplementary Information adopted
on 13.10.2016.
Esbriet - pirfenidone -
EMEA/H/C/002154/II/0039, Orphan
MAH: Roche Registration Limited, Rapporteur:
Greg Markey
Request for Supplementary Information adopted
on 27.10.2016.
Foclivia - influenza virus surface antigens
(inactivated) of strain
A/Vietnam/1194/2004 (H5N1) -
EMEA/H/C/001208/II/0023/G
MAH: Seqirus S.r.l, Rapporteur: Daniela
Melchiorri
Request for Supplementary Information adopted
on 27.10.2016.
Gazyvaro - obinutuzumab -
EMEA/H/C/002799/II/0013/G, Orphan
MAH: Roche Registration Limited, Rapporteur:
Sinan B. Sarac
Request for Supplementary Information adopted
on 13.10.2016.
Ixiaro - japanese encephalitis vaccine
(inactivated, adsorbed) -
EMEA/H/C/000963/II/0083
MAH: Valneva Austria GmbH, Rapporteur: Jan
Mueller-Berghaus
Nulojix - belatacept -
EMEA/H/C/002098/II/0034/G
MAH: Bristol-Myers Squibb Pharma EEIG,
Rapporteur: Filip Josephson
Opinion adopted on 17.11.2016.
Request for Supplementary Information adopted
on 15.09.2016, 09.06.2016.
Positive Opinion adopted by consensus on
24.11.2016. The Icelandic and Norwegian CHMP
Members were in agreement with the CHMP
recommendation.
Weekly start timetable.
Weekly start timetable.
Weekly start timetable.
Weekly start timetable.
Positive Opinion adopted by consensus on
17.11.2016. The Icelandic and Norwegian CHMP
Members were in agreement with the CHMP
recommendation.
Annex to December 2016 CHMP Agenda
EMA/CHMP/819197/2016 Page 11/55