ongoing

Lodewijk Hillege, “Update of sections 4.2 and
5.1 of the SmPC in order to update the
documented treatment effect currently limited
to 1 year. The proposed update of the current
labelling for long-term efficacy, safety and
tolerable use in the management of obesity is
based on 3-year data from trial 1839.
recommendation.
In addition, the Marketing authorisation holder
took the opportunity to bring the PI in line with
the latest QRD template version 10 and
implement minor linguistic updates.”
Opinion adopted on 01.12.2016.
Request for Supplementary Information adopted
on 29.09.2016.
Stivarga - regorafenib -
EMEA/H/C/002573/II/0018
MAH: Bayer Pharma AG, Rapporteur: Paula
Boudewina van Hennik, “Update the SmPC
section 4.2 and 5.2 based on results from phase
1 study which evaluated the pharmacokinetics
and safety of regorafenib in cancer subjets with
severe renal impairment compared to cancer
subjects without or mild renal impairment. The
package leaflet is updated accordingly.”
Request for Supplementary Information adopted
on 13.10.2016.
Strensiq - asfotase alfa -
EMEA/H/C/003794/II/0008, Orphan
MAH: Alexion Europe SAS, Rapporteur: Greg
Markey, PRAC Rapporteur: Almath Spooner,
“Update of sections 4.4 and 4.8 of the SmPC in
order to reinforce the wording on the risk of
anaphylaxis. The Package Leaflet is updated
accordingly. The MAH took th eopportunity to
include the Pharmacotherapeutic group in
section 5.1.”
Request for Supplementary Information adopted
on 13.10.2016, 21.07.2016.
Tamiflu - oseltamivir -
EMEA/H/C/000402/II/0122
MAH: Roche Registration Limited, Rapporteur:
Outi Mäki-Ikola, PRAC Rapporteur: Kirsti
Villikka, “Update of section 5.1 of the SmPC and
RMP to reflect the results of study IRIS
(NV20237) a prospective, multicenter,
information-gathering study, comprising
virological surveillance and assessment of
clinical outcomes, which enrolled patients over a
7-year period.
Annex to December 2016 CHMP Agenda
EMA/CHMP/819197/2016 Page 22/55