Ameluz
5-aminolevulinic acid hydrochloride
Table of contents
Overview
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.
Authorisation details
Product details | |
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Name |
Ameluz
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Agency product number |
EMEA/H/C/002204
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Active substance |
5-aminolevulinic acid hydrochloride
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International non-proprietary name (INN) or common name |
5-aminolevulinic acid hydrochloride
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01XD04
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Publication details | |
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Marketing-authorisation holder |
Biofrontera Bioscience GmbH
|
Revision |
19
|
Date of issue of marketing authorisation valid throughout the European Union |
13/12/2011
|
Contact address |
Hemmelrather Weg 201
D-51377 Leverkusen Germany |
Product information
22/03/2022 Ameluz - EMEA/H/C/002204 - N/0052
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
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
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 202031/01/2020
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16/12/2016
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22/07/2016