SCENESSE - Afamelanotide -
EMEA/H/C/002548/II/0052, Orphan
Clinuvel Europe Limited, Rapporteur: Janet
Koenig, PRAC Rapporteur: Martin Huber ,
“Update of section 4.2 of the SmPC in order to
update the posology recommendations by
removing the current recommendation of a
maximum of four implants per year, based on a
literature review and analysis of safety data.
The Package Leaflet is updated accordingly. The
RMP version 9.8 has also been submitted. In
addition, the MAH took the opportunity to
introduce a minor editoria
https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-27-30-may-2024_en.pdf
Scenesse expanding to 4+ implants annually in the EU?
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