ongoing

present time as these contain commercially confidential information.
B.5.1. CHMP assessed procedures scope: Pharmaceutical aspects
Adcetris - brentuximab vedotin -
EMEA/H/C/002455/II/0041/G, Orphan
MAH: Takeda Pharma A/S, Rapporteur: Paula
Boudewina van Hennik
Advate - octocog alfa -
EMEA/H/C/000520/II/0082/G
MAH: Baxter AG, Rapporteur: Jan Mueller-
Berghaus
Weekly start timetable.
Weekly start timetable.
Bemfola - follitropin alfa -
EMEA/H/C/002615/II/0011
MAH: Gedeon Richter Plc., Rapporteur: Paula
Boudewina van Hennik
Cerezyme - imiglucerase -
EMEA/H/C/000157/II/0099/G
MAH: Genzyme Europe BV, Rapporteur: Johann
Lodewijk Hillege
Request for Supplementary Information adopted
on 16.02.2017.
Cimzia - certolizumab pegol -
EMEA/H/C/001037/II/0058/G
MAH: UCB Pharma S.A., Rapporteur: Kristina
Dunder
Colobreathe - colistimethate sodium -
EMEA/H/C/001225/II/0023
MAH: Teva B.V., Rapporteur: Nithyanandan
Nagercoil
Request for Supplementary Information adopted
on 17.11.2016, 12.05.2016, 03.03.2016.
Cosentyx - secukinumab -
EMEA/H/C/003729/II/0017
MAH: Novartis Europharm Ltd, Rapporteur:
Tuomo Lapveteläinen
Darzalex - daratumumab -
EMEA/H/C/004077/II/0004, Orphan
MAH: Janssen-Cilag International NV,
Rapporteur: Sinan B. Sarac
Darzalex - daratumumab -
EMEA/H/C/004077/II/0005/G, Orphan
MAH: Janssen-Cilag International NV,
Rapporteur: Sinan B. Sarac
Emtricitabine/Tenofovir disoproxil Zentiva
- emtricitabine / tenofovir disoproxil -
Weekly start timetable. The Committee
adopted a Request for Supplementary
information together with a specific timetable.
Weekly start timetable.
Weekly start timetable.
Weekly start timetable.
Weekly start timetable.
Weekly start timetable.
Weekly start timetable.
Annex to February 2017 CHMP Agenda
EMA/CHMP/117606/2017 Page 9/66