Committee for medicinal products for human use (CHMP)

vaccines (i.e. Twinrix Adult, Twinrix Paediatric
and Ambirix).”
Request for Supplementary Information adopted
on 21.07.2016.
Bydureon - exenatide -
EMEA/H/C/002020/II/0038
MAH: AstraZeneca AB, Rapporteur: Kristina
Dunder, , “Submission of the final results of study
2993LAR-105 to examine the effects of exenatide
once weekly on glucose control and safety in
subjects with type II diabetes mellitus managed
with diet modification and exercise and/or oral
anti-diabetic medications.”
Request for Supplementary Information adopted
on 15.09.2016.
Weekly start timetable.
Cervarix - human papillomavirus vaccine
[types 16, 18] (recombinant, adjuvanted,
adsorbed) - EMEA/H/C/000721/II/0080
MAH: GSK Biologicals SA, Rapporteur: Bart Van
der Schueren, “Submission of final Study report
for study HPV-060. Study HPV-060 is an
extension of the study HPV-014 (EXT 014 Y5-10).
Study HPV-014 with 4 years post-vaccination
data was submitted as a commitment in
November 2009 (EMEA/H/C/721/FU2 20.5)
The purpose of this variation is to fulfil the
Post-Authorization Measure (PAM) (MEA-082)
with the long term follow up (10 years
post-vaccination) data from study HPV-060.
GlaxoSmithKline Biologicals (GSK Biologicals)
considers that there is no need to change the
SmPC at this stage.”
Request for Supplementary Information adopted
on 15.09.2016.
Effentora - fentanyl -
EMEA/H/C/000833/II/0044
MAH: Teva B.V., Rapporteur: Martina Weise,
“Update of sections 4.4, 4.6 and 4.8 as applicable
of the SmPC in order to add a warning on adrenal
insufficiency, androgen deficiency and Neonatal
withdrawal syndrome following a request from
FDA to introduce a class label safety warning. The
PL was updated accordingly.
In addition, the Marketing authorisation holder
(MAH) took the opportunity to bring the PI in line
with the latest QRD template version 10.0 and to
apply a combined SmPC”
Fycompa - perampanel -
EMEA/H/C/002434/II/0030
Positive Opinion adopted by consensus on
20.10.2016. The Icelandic and Norwegian CHMP
Annex to November 2016 CHMP Agenda
EMA/CHMP/682759/2016 Page 12/43