Ameluz
What Ameluz is used for
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.
Approved use, as published by the European Medicines Agency.
Key facts
- Brand
- Ameluz
- Active substance
- 5-aminolevulinic acid hydrochloride
- Disease area
- Keratosis, Actinic; Carcinoma, Basal Cell
- Medicine group
- Antineoplastic agents
- ATC code
- L01XD04
- Marketing authorisation holder
- Biofrontera Bioscience GmbH
- Authorised in the EU since
- 2011
Official information
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Ameluz used for?
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.
What is the active substance in Ameluz?
Ameluz contains 5-aminolevulinic acid hydrochloride.
Who makes Ameluz?
The EU marketing authorisation holder is Biofrontera Bioscience GmbH.
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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