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EMA approval · 2026-06-03

EMA Authorised: Ameluz (5-aminolevulinic acid hydrochloride) — Biofrontera Bioscience GmbH

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Summary

EMA authorised Ameluz (5-aminolevulinic acid hydrochloride) for actinic keratosis and basal cell carcinoma.

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Diseases / indications

Drugs mentioned

  • AMELUZ (AMINOLEVULINIC ACID HYDROCHLORIDE)

Snippet

Status: Authorised. Therapeutic area: Keratosis, Actinic;Carcinoma, Basal Cell. MAH: Biofrontera Bioscience GmbH. Decision date: 03/06/2026