Committee for medicinal products for human use (CHMP)

template version 10.”
OPDIVO - nivolumab -
EMEA/H/C/003985/II/0023
MAH: Bristol-Myers Squibb Pharma EEIG,
Rapporteur: Aranzazu Sancho-Lopez, “Update of
sections 4.8 and 5.1 of the SmPC in order to
update the safety and pharmacological
information with the 24 months data from the
completed NSCLC studies CA209017 and
CA209057.”
Travatan - travoprost -
EMEA/H/C/000390/II/0053
MAH: Alcon Laboratories (UK) Ltd, Rapporteur:
Concepcion Prieto Yerro, “Following the
submission of final CSR for study C-01-79 and a
review of supporting clinical studies and
post-marketing data, update to SmPC section 4.8
is proposed. The package leaflet is updated
accordingly.
In addition, MAH took the opportunity to update
number of the Spanish representative in the PL.”
Triumeq - dolutegravir / abacavir /
lamivudine - EMEA/H/C/002754/II/0035
MAH: ViiV Healthcare UK Limited, Rapporteur:
Kristina Dunder, “Update of section 5.1 of the
SmPC to include Week 48 data from the Phase
IIIb clinical study ING117172 (ARIA) to support
the use of Triumeq in HIV-infected antiretroviral
(ART)-naïve women.”
Triumeq - dolutegravir / abacavir /
lamivudine - EMEA/H/C/002754/II/0036
MAH: ViiV Healthcare UK Limited, Rapporteur:
Kristina Dunder, “Update of section 5.1 of the
SmPC to include Week 24 (primary analysis) and
Week 48 data from the Phase IIIb clinical study
201147 (STRIIVING), to support the use of
Triumeq in HIV-infected antiretroviral
(ART)-experienced adults.”
Xagrid - anagrelide -
EMEA/H/C/000480/II/0074, Orphan
MAH: Shire Pharmaceutical Contracts Ltd.,
Rapporteur: Pierre Demolis, , “Submission of the
final Clinical Study Report of the study
SPD422-403, a phase IIIb, randomised,
open-label study conducted as a specific
obligation to compare the safety, efficacy, and
tolerability of anagrelide hydrochloride versus
hydroxyurea in high-risk essential
Annex to November 2016 CHMP Agenda
EMA/CHMP/682759/2016 Page 40/43