5-aminolevulinic acid hydrochloride

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 11/03/2021

Authorisation details

Product details
Agency product number
Active substance
5-aminolevulinic acid hydrochloride
International non-proprietary name (INN) or common name
5-aminolevulinic acid hydrochloride
Therapeutic area (MeSH)
  • Keratosis, Actinic
  • Carcinoma, Basal Cell
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Biofrontera Bioscience GmbH
Date of issue of marketing authorisation valid throughout the European Union
Contact address
Hemmelrather Weg 201
D-51377 Leverkusen

Product information

19/02/2021 Ameluz - EMEA/H/C/002204 - IB/0045/G


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Pharmacotherapeutic group

Antineoplastic agents

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.

Assessment history

Changes since initial authorisation of medicine

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