Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: Ameluz   
Auth. number : EU/1/11/740
Active substance : 5-Aminolaevulinic acid
ATC: Anatomical main group: L - Antineoplastic and immunomodulating agents
Therapeutic subgroup: L01 - Antineoplastic agents
Pharmacological subgroup: L01X - Other antineoplastic agents
Chemical subgroup: L01XD - Sensitizers used in photodynamic/radiation therapy
Chemical substance: L01XD04 - aminolevulinic acid
(See WHO ATC Index)
Indication: Treatment of actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2) 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.
Marketing Authorisation Holder: Biofrontera Bioscience GmbH
Hemmelrather Weg 201, 51377 Leverkusen, Deutschland
EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.

European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
19/12/2011 Centralised - Authorisation EMEA/H/C/2204 (2011)9739 of 14/12/2011
24/01/2012 Corrigendum (2011)9739 of 14/12/2011
03/08/2012 Centralised - Notification EMEA/H/C/2204/N/1
Updated with Decision(2014)338 of 17/01/2014
04/01/2013 Centralised - Variation EMEA/H/C/2204/IB/3/G
Updated with Decision(2014)338 of 17/01/2014
23/05/2013 Centralised - Notification EMEA/H/C/2204/N/5
Updated with Decision(2014)338 of 17/01/2014
18/12/2013 Centralised - Notification EMEA/H/C/2204/N/8
Updated with Decision(2014)338 of 17/01/2014
21/01/2014 Centralised - Yearly update (2014)338 of 17/01/2014
26/01/2015 Centralised - Notification EMEA/H/C/2204/N/14
Updated with Decision(2016)5862 of 09/09/2016
31/03/2016 Centralised - Variation EMEA/H/C/2204/IB/21
Updated with Decision(2016)5862 of 09/09/2016
13/09/2016 Centralised - 2-Monthly update EMEA/H/C/2204/II/20 (2016)5862 of 09/09/2016
23/11/2016 Centralised - Renewal EMEA/H/C/2204/R/23 (2016)7679 of 21/11/2016
31/01/2017 Centralised - 2-Monthly update EMEA/H/C/2204/II/24 (2017)582 of 27/01/2017
05/03/2018 Centralised - 2-Monthly update EMEA/H/C/2204/II/27G (2018)1424 of 01/03/2018