ongoing

EEIG, Rapporteur: Bruno Sepodes, PRAC
Rapporteur: Claire Ferard, “14 January 2016 -
28 July 2016”
EMEA/H/C/PSUSA/00010447/201607
(brivaracetam)
CAPS:
Briviact (EMEA/H/C/003898) (brivaracetam),
MAH: UCB Pharma S.A., Rapporteur: Filip
Josephson, PRAC Rapporteur: Adam
Przybylkowski, “15/01/2016-14/07/2016”
B.4. EPARs / WPARs
AMGEVITA - adalimumab -
EMEA/H/C/004212
Applicant: Amgen Europe B.V., treatment of
rheumatoid arthritis, juvenile idiopathic arthritis,
axial spondyloarthritis, psoriatic arthritis,
psoriasis, paediatric plaque psoriasis,
hidradenitis suppurativa, Crohn's disease,
paediatri Crohn's disease and Ulcerative colitis,
Similar biological application (Article 10(4) of
Directive No 2001/83/EC)
Daptomycin Hospira - daptomycin -
EMEA/H/C/004310
Applicant: Hospira UK Limited, treatment of
complicated skin and soft-tissue infections,
Generic, Generic of Cubicin, Generic application
(Article 10(1) of Directive No 2001/83/EC)
Jylamvo - methotrexate -
EMEA/H/C/003756
Applicant: Therakind Limited, treatment of
rheumatological and dermatological diseases,
Hybrid application (Article 10(3) of Directive No
2001/83/EC)
LifeGlobal Media - human serum albumin -
EMEA/H/D/004287
Applicant: BSI Group, washing, handling,
manipulation and/or cryopreservation of
gametes and embryos for assisted human
reproductive technology
vitamins which may be present in trace
quantities and acts as a carrier of these
substances to support
growth and maintenance of gametes and/or
embryos. Scavenges embryotoxic components
generated
prevents adsorption to the container of various
Annex to February 2017 CHMP Agenda
EMA/CHMP/117606/2017 Page 7/66