CUV 1.02% $14.59 clinuvel pharmaceuticals limited

Scenesse expanding to 4+ implants annually in the EU?

  1. 68 Posts.
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    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
 
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