010 schreef op 26 februari 2018 11:55:
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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 opinion
Other
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.
www.ema.europa.eu/docs/en_GB/document...