Ameluz

RSS

5-aminolevulinic acid hydrochloride

Authorised
This medicine is authorised for use in the European Union.

Overview

Ameluz is a medicine used in adults to treat mild to moderate actinic keratoses on the face and scalp as well as the surrounding areas of the skin affected by the condition. Actinic keratoses are 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 03/08/2018

Authorisation details

Product details
Name
Ameluz
Agency product number
EMEA/H/C/002204
Active substance
5-aminolevulinic acid hydrochloride
International non-proprietary name (INN) or common name
5-aminolevulinic acid hydrochloride
Therapeutic area (MeSH)
Keratosis, Actinic
Anatomical therapeutic chemical (ATC) code
L01XD04
Publication details
Marketing-authorisation holder
Biofrontera Bioscience GmbH
Revision
12
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

23/07/2018 Ameluz - EMEA/H/C/002204 - N/0030

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

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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

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