Committee for medicinal products for human use (CHMP)

Feraccru - iron -
EMEA/H/C/002733/II/0002/G
MAH: Shield TX (UK) Ltd, Rapporteur:
Concepcion Prieto Yerro, PRAC Rapporteur: Adam
Przybylkowski“Submission of two final study
reports for in vitro studies conducted as part of
post-authorisation measures MEA 001 and MEA
002 :
- One drug-drug interaction study to investigate
drug interactions with Feraccru
- One drug-drug interaction study to identify UGT
isoenzyme(s) that are responsible for metabolism
of ferric maltol.
Consequential changes have been made to the
RMP to reflect the completion of the studies.”
Request for Supplementary Information adopted
on 15.09.2016.
Firdapse - amifampridine -
EMEA/H/C/001032/II/0043, Orphan
MAH: BioMarin Europe Ltd, Rapporteur: Greg
Markey, PRAC Rapporteur: Julie Williams,
“Update of sections 4.4 and 5.3 of the SmPC
respectively in order to delete the statements
that amifampridine has not been fully tested in
carcinogenicity models and to provide the
findings from the carcinogenicity reports required
for the completion of SOB 004.
The RMP (v.9) is proposed to be updated
accordingly.
In addition, the Marketing authorisation holder
(MAH) took the opportunity to request the
removal of the requirement to complete
carcinogenicity testing in an appropriate model in
section E of the Annex II.”
Request for Supplementary Information adopted
on 15.09.2016.
Iclusig - ponatinib -
EMEA/H/C/002695/II/0032/G, Orphan
MAH: ARIAD Pharma Ltd, Rapporteur: Greg
Markey, PRAC Rapporteur: Rafe Suvarna“Update
of sections 4.2, 4.4, 4.8, 5.1 of the SmPC based
on data from the ongoing Study AP24534-07-101
with a median duration of follow‐up of
approximately 48 months for the CP‐CML patients
and 3.6 months for the advanced phase Ph+
leukemia patients, as well as 48-month follow-up
data from the ongoing Study AP24534-10-201
(PACE). The Package Leaflet has been updated
accordingly. In addition, the MAH took the
opportunity to make minor editorial changes in
Annex to November 2016 CHMP Agenda
EMA/CHMP/682759/2016 Page 22/43