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add drug-drug interaction information based<br />
upon the PK analysis of Study 3066K1-148-US<br />
and supportive literature. The Package Leaflet is<br />
updated accordingly.”<br />
Translarna - ataluren -<br />
EMEA/H/C/002720/II/0016/G, Orphan<br />
MAH: PTC Therapeutics International Limited,<br />
Rapporteur: Johann Lodewijk Hillege, PRAC<br />
Rapporteur: Sabine Straus, “Update of section<br />
4.4 to remove precautions for use relating to<br />
the co-administration of ataluren with<br />
substrates or inducers of UGT1A9 and section<br />
4.5 of the SmPC to remove statements relating<br />
to the potential effect of co-administration of<br />
ataluren with inducers or substrates of UGT1A9<br />
and to add results from studies PTC124-GD-<br />
026-HV and PTC124-GD-027-HV (MEA 011 and<br />
MEA 012). The Package Leaflet is updated<br />
accordingly.<br />
In addition, the Marketing authorisation holder<br />
(MAH) took the opportunity to make minor<br />
editorial changes to the SmPC. Moreover, the<br />
updated RMP version 4.2 has been submitted.”<br />
Request for Supplementary Information adopted<br />
on 10.11.2016, 15.09.2016, 23.06.2016,<br />
28.04.2016, 28.01.2016.<br />
Translarna - ataluren -<br />
EMEA/H/C/002720/II/0020, Orphan<br />
MAH: PTC Therapeutics International Limited,<br />
Rapporteur: Johann Lodewijk Hillege, PRAC<br />
Rapporteur: Sabine Straus, “Update of sections<br />
4.4, 4.8, 5.1 and 5.3 of the SmPC in order to<br />
reflect the results from the submitted study<br />
TC124-GD-020-DMD object of the specific<br />
obligation (SOB 001) for the conditional<br />
marketing authorisation. The Package Leaflet<br />
and the RMP are updated accordingly. In<br />
addition, the Marketing authorisation holder<br />
(MAH) took the opportunity to include some<br />
minor editorial changes throughout the Product<br />
information.”<br />
Opinion adopted on 23.11.2016.<br />
Request for Supplementary Information adopted<br />
on 13.10.2016, 21.07.2016, 23.06.2016,<br />
01.04.2016.<br />
SAG meeting held on 29.09.2016, 16.06.2016.<br />
Positive Opinion adopted by consensus on<br />
23.11.2016. The Icelandic and Norwegian CHMP<br />
Members were in agreement with the CHMP<br />
recommendation.<br />
Xgeva - denosumab -<br />
EMEA/H/C/002173/II/0046<br />
MAH: Amgen Europe B.V., Rapporteur: Kristina<br />
Annex to December 2016 CHMP Agenda<br />
EMA/CHMP/819197/2016 Page 38/55
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