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🇪🇺EU · EMAAuthorisedATC: L01XD04

Ameluz(5-aminolevulinic acid hydrochloride)

Keratosis, Actinic;Carcinoma, Basal Cell

Marketing Authorisation Holder: Biofrontera Bioscience GmbH

EMA Authorisation: 13/12/2011

INN: 5-aminolevulinic acid hydrochloride

Indication

Treatment of actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2; see section 5.1) and of field cancerization in adults. Treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment due to possible treatment-related morbidity and/or poor cosmetic outcome in adults.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.