Basic Information
Ameluz
Regulatory Information
EMEA/H/C/002204
December 13, 2011
October 20, 2011
21
March 5, 2024
Company Information
Germany
Hemmelrather Weg 201 D-51377 Leverkusen
Biofrontera Bioscience GmbH
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic 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.
Overview Summary
Ameluz is a medicine used in adults to treat mild to moderate actinic keratoses, skin growths caused by exposure to sunlight, which can lead to skin cancer. It may also be used to treat an area of sun-induced skin damage with multiple actinic keratosis growths (field cancerisation). Ameluz can also be used in adults to treat certain types of basal cell carcinoma (a type of skin cancer) when it cannot be treated by surgery. Ameluz contains the active substance 5-aminolaevulinic acid.