Committee for medicinal products for human use (CHMP)

WS0998
OFEV-EMEA/H/C/003821/WS0998/0011
Vargatef-EMEA/H/C/002569/WS0998/001
3
MAH: Boehringer Ingelheim International GmbH,
Lead Rapporteur: Sinan B. Sarac, “Update of
section 4.8 of the SmPC in order to include
‘thrombocytopenia’ as new ADR with a ‘common’
frequency for Vargated and an ‘uncommon’
frequency for Ofev. The Package Leaflet is
updated accordingly.
In addition, the Worksharing applicant (WSA)
took the opportunity to introduce minor
corrections to the English, Croatian and Slovak
Annexes for Vargated and to the Slovak Annexes
for Ofev and to bring the Product Information in
line with the latest QRD template version 10.”
WS1004
Ultibro
Breezhaler-EMEA/H/C/002679/WS1004/0
012
Ulunar
Breezhaler-EMEA/H/C/003875/WS1004/0
012
Xoterna
Breezhaler-EMEA/H/C/003755/WS1004/0
014
MAH: Novartis Europharm Ltd, Lead Rapporteur:
Hanne Lomholt Larsen, “Update of section 5.1 of
the summary of product characteristics (SmPC)
to reflect the final results of study
CQVA149A2318 “A 52-week treatment,
multi-center, randomised, double-blind, double
dummy, parallel-group, active controlled study to
compare the effect of QVA149 (indacaterol
maleate/glycopyrronium bromide) with
salmeterol/fluticasone (salm/flut) on the rate of
exacerbations in subjects with moderate to very
severe COPD”.
In addition, the MAH took this opportunity to
more accurately reflect the mean pre-dose values
at week 64 from clinical study CQVA149A2304
report, included in the original marketing
authorisation application.”
Request for Supplementary Information adopted
on 15.09.2016.
Weekly start timetable.
Weekly start timetable.
WS1010
Descovy-EMEA/H/C/004094/WS1010/000
6
Genvoya-EMEA/H/C/004042/WS1010/001
Annex to November 2016 CHMP Agenda
EMA/CHMP/682759/2016 Page 19/43