Sharen schreef op 28 januari 2025 10:46:
Volledig aan ieders zicht ontrokken was er op 16 januari zowaar weer eens een 'positive opinion' for Ruconest bij EMA:
www.ema.europa.eu/en/documents/agenda...------
PRAC Led
Ruconest - Conestat alfa -
EMEA/H/C/001223/II/0088/G
Pharming Group N.V, PRAC Rapporteur: Jan
Neuhauser, PRAC-CHMP liaison: Daniela
Positive Opinion adopted by consensus on
16.01.2025.
EMA/CHMP/585933/2024 Page 44/84
Philadelphy, “Submission of an updated RMP
version 20.0 in order to request the early
termination of the EU registry study C1 1412, as
well as to update safety information based on
cumulative data from clinical trials, the EU
registry data, post-marketing data and
literature. A request for the extension of the due
date for the European survey of educational
materials for Ruconest is also included.”
Opinion adopted on 16.01.2025.
Request for Supplementary Information adopted
on 03.10.2024.
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