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EMA Adopts a New Indication for 5-Aminolevulinic Acid

New indication concerns the treatment of superficial and/or nodular basal cell carcinoma unsuitable for surgical treatment
23 Dec 2016
Melanoma and other skin tumours;  Anticancer agents & Biologic therapy

On 15 December 2016, the European Medicines Agency’s (EMA’s) 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 5-aminolevulinic acid (Ameluz).

The marketing authorisation holder for this medicinal product is Biofrontera Bioscience GmbH.

The CHMP adopted a new indication as follows:

“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.”

For information, the full indications for Ameluz will be as follows:

“Treatment of actinic keratosis of mild to moderate severity on the face and scalp (Olsen grade 1 to 2) and of field cancerisation 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, which will be published in the revised European public assessment report, 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.

Last update: 23 Dec 2016

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