In further evidence of recent incremental gains for Clinuvel, I found this from the European Medicines Agency meeting agenda for this week. IMO there could be some good growth still to come for EPP if Europe start to give out 6 or more implants instead of 3 or 4. More implants gives EPP sufferers year round peace of mind, hopefully the kids get this too if implemented.
SCENESSE
Applicant: Clinuvel Europe Limited
Scope: 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 editorial change to the product information
Action: For adoption of PRAC RMP AR, PRAC RMP assessment overview and advice to CHMP
In further evidence of recent incremental gains for Clinuvel, I...
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