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EMA Greenlights Year-Round SCENESSE® for EPP, Lifting Dose Caps
8:42am on Tuesday 23rd of September, 2025 AEST
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Pharmaceuticals
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EMA Greenlights Year-Round SCENESSE® for EPP, Lifting Dose Caps
8:42am on Tuesday 23rd of September, 2025 AEST
Key Points
EMA removes maximum annual dose limit for SCENESSE®
Year-round treatment now approved for adult EPP patients in Europe
Approval based on over 15 years of clinical trial and real-world data
European label harmonised with US FDA dosing regimen
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Clinuvel Pharmaceuticals (ASX:CUV)
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