Committee for medicinal products for human use (CHMP)

MAH: Janssen-Cilag International N.V.,
Rapporteur: Filip Josephson, Co-Rapporteur:
Karsten Bruins Slot, PRAC Rapporteur: Qun-Ying
Yue
Translarna - ataluren -
EMEA/H/C/002720/R/0022, Orphan
MAH: PTC Therapeutics International Limited,
Rapporteur: Johann Lodewijk Hillege, PRAC
Rapporteur: Sabine Straus
Request for Supplementary Information adopted
on 28.04.2016.
See main part of agenda points 2.3.1 and 9.1.2.
B.3. POST-AUTHORISATION PHARMACOVIGILANCE OUTCOMES
PSUR procedures for which PRAC adopted a
recommendation for variation of the terms of
the MA at its October 2016 meeting:
EMEA/H/C/PSUSA/00001353/201604
(febuxostat)
CAPS:
Adenuric (EMEA/H/C/000777) (febuxostat),
MAH: Menarini International Operations
Luxembourg S.A., Rapporteur: Andrea Laslop,
PRAC Rapporteur: Jan Neuhauser, “21/04/2015 -
20/04/2016”
EMEA/H/C/PSUSA/00010272/201603
(insulin degludec / liraglutide)
CAPS:
Xultophy (EMEA/H/C/002647) (insulin degludec
/ liraglutide), MAH: Novo Nordisk A/S,
Rapporteur: Kristina Dunder, PRAC Rapporteur:
Menno van der Elst, “01 Oct 2015 - 31 March
2016”
B.4. EPARs / WPARs
Cystadrops - mercaptamine -
EMEA/H/C/003769, Orphan
Applicant: Orphan Europe S.A.R.L., treatment of
cystinosis, Known active substance (Article 8(3)
of Directive No 2001/83/EC)
Emtricitabine/Tenofovir disoproxil Krka -
emtricitabine / tenofovir disoproxil -
EMEA/H/C/004215
Applicant: KRKA, d.d., Novo mesto, treatment of
HIV-1 infection, Generic, Generic of Truvada,
Generic application (Article 10(1) of Directive No
2001/83/EC)
Annex to November 2016 CHMP Agenda
EMA/CHMP/682759/2016 Page 6/43