Committee for medicinal products for human use (CHMP)

Ebymect-EMEA/H/C/004162/WS0968/001
2
Edistride-EMEA/H/C/004161/WS0968/00
09
Forxiga-EMEA/H/C/002322/WS0968/002
8
Xigduo-EMEA/H/C/002672/WS0968/0023
MAH: AstraZeneca AB, Lead PRAC Rapporteur:
Qun-Ying Yue, “To provide a revised RMP in order
to implement the recommendations given in the
Article 20 assessment report dated 18th February
(EMA/PRAC/50218/2016). The changes
introduced are the following:
- The inclusion of atypical DKA as an identified
Risk.
- Upgrade of a DUS from category 4 to 3 'required
additional pharmacovigilance activities to
address specific safety concerns or to measure
effectiveness of risk minimisation measures'.
- Addition of a description of an ongoing
mechanistic study. This is a short description as it
is an ongoing post-doctorate research project
and no protocol will be reviewed.
- Addition of a description of a DKA
epidemiological study assessing the incidence of
DKA to the RMP.”
Request for Supplementary Information adopted
on 15.09.2016.
PRAC Led
WS1005
Ultibro
Breezhaler-EMEA/H/C/002679/WS1005/0
013
Ulunar
Breezhaler-EMEA/H/C/003875/WS1005/0
013
Xoterna
Breezhaler-EMEA/H/C/003755/WS1005/0
015
MAH: Novartis Europharm Ltd, Lead Rapporteur:
Hanne Lomholt Larsen, Lead PRAC Rapporteur:
Torbjorn Callreus, “Update of the SmPC section
4.8 to add Dysphonia and revise the ADRs
selection and frequencies based on the MAH’s
review of all safety data. As a consequence,
section 4.4 was updated.
The Package Leaflet is updated accordingly.
The MAH took the opportunity of this procedure
to update the Product Information as per the
latest QRD template.
Annex to November 2016 CHMP Agenda
EMA/CHMP/682759/2016 Page 36/43