beurs en gevoelig... schreef op 20 maart 2018 15:40:
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hi Burdie, maar er zitten nog 2 momenten tussen, wat vind je daar van dan?
report of opinions op 18 januari 2018(zie papierwerk bij de december meetings):
Opinions on modifications to an agreed PIP The PDCO also adopts, every month, opinions on modifications to an agreed PIP, which can be requested by the applicant when the plan is no longer appropriate or when there are difficulties that render the plan unworkable.
The PDCO adopted positive opinions, agreeing change(s), for the following products:
Conestat alfa, EMEA-000367-PIP01-08-M07, from Pharming Group N.V., for the treatment of hereditary angioedema (HAE)de minutes van 22 februari 2018(zie papierwerk bij de december meetings):
2.3.19. Conestat alfa - EMEA-000367-PIP01-08-M07
Pharming Group N.V.; D84.1 Defects in the complement system C1 esterase inhibitor
(C1-INH) deficiency / Treatment of acute attacks of angioedema associated with
hereditary C1 esterase inhibitor deficiency
Day 60 opinionOther
Summary of committee discussion:
Based on the review of the rationale submitted by the applicant for modifying the agreed paediatric investigation plan, the PDCO considered that the majority of the proposed changes could be accepted.
The PDCO therefore adopted a favourable Opinion on the modification of the agreed PIP as set in the Agency’s latest decision (P/0052/2017 of 17/03/2017).
The new PDCO Opinion on the modified agreed PIP supersedes the previous PDCO
Opinion.