Committee for medicinal products for human use (CHMP)

eference medicinal product) through variation
EMEA/H/C/004066/X/0007/G.”
Request for Supplementary Information adopted
on 15.09.2016.
Zoely - nomegestrol / estradiol -
EMEA/H/C/001213/II/0037
MAH: Teva B.V., Rapporteur: Joseph Emmerich,
“Update of section 4.2 of the SmPC concerning
reduced efficacy with regard to concomitant
medications and section 4.5 of the SmPC
concerning hepatic metabolism and HIV/HCV
interactions. The Package Leaflet has been
updated accordingly.”
Zoely - nomegestrol / estradiol -
EMEA/H/C/001213/II/0038
MAH: Teva B.V., Rapporteur: Joseph Emmerich,
“Update of sections 4.4 and 4.5 of the SmPC
concerning Hepatitis C and the risk of elevated
ALT due to treatment with the HCV combination
regimen ombitasvir/paritaprevir/ritonavir
co-administered with ethinylestradiol-containing
products. The Package Leaflet has been updated
accordingly. In addition, the MAH took the
opportunity to make minor editorial changes in
the SmPC and Package Leaflet.”
Zydelig - idelalisib -
EMEA/H/C/003843/II/0025
MAH: Gilead Sciences International Ltd,
Rapporteur: Filip Josephson, “Submission of the
final report for a study of mechanisms of
resistance to idelalisib in patients with chronic
lymphocytic leukemia (CLL) in fulfilment of
post-authorization measure (PAM) 013 for
Zydelig.”
Request for Supplementary Information adopted
on 15.09.2016.
Weekly start timetable.
Weekly start timetable.
Weekly start timetable.
WS0919
Exviera-EMEA/H/C/003837/WS0919/0015
Viekirax-EMEA/H/C/003839/WS0919/001
5
MAH: AbbVie Ltd., Lead Rapporteur: Filip
Josephson, “Update of sections 4.2, 4.8, 5.1 and
5.2 of the SmPC in order to reflect the findings of
study M14-226 in patients with HCV infection and
several renal impairment or End Stage Renal
Disease.”
Request for Supplementary Information adopted
on 15.09.2016, 01.04.2016.
Annex to November 2016 CHMP Agenda
EMA/CHMP/682759/2016 Page 18/43