Ameluz

5-aminolevulinic acid hydrochloride

Table of contents

Opinion

On 30 January 2020, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product Ameluz. The marketing authorisation holder for this medicinal product is Biofrontera Bioscience GmbH.

The CHMP adopted an extension to the existing indication as follows:1

“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.”

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.


1 Removed text as strikethrough.

Key facts

Name
Ameluz
Agency product number
EMEA/H/C/002204
International non-proprietary name (INN) or common name
  • 5-aminolevulinic acid hydrochloride
Active substance
  • 5-aminolevulinic acid hydrochloride
Therapeutic area
Keratosis, Actinic
Carcinoma, Basal Cell
Date opinion adopted
30/01/2020
Company name
Biofrontera Bioscience GmbH
Status
Positive
Application type
Post-authorisation

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