26-10-2011: The European Medicines Agency (EMA) issued a favourable opinion on Biofrontera's marketing approval application for its new medicinal product BF-200 ALA for the treatment of actinic keratosis. There was no recommendation for a restriction or temporal limitation of the approval. The product will be marketed under the name Ameluz®. The positive assessment report on the product, generated by the responsible committee within the EMA, the Committee for Medicinal Products for Human Use (CHMP), will now be forwarded to the European Commission for the formal conclusion of the process. Before the marketing approval will be issued, anticipated in December, the product information will be translated into all languages of the European Union and attuned with the respective local health agencies. Following approval, Ameluz® can be commercialized in all 27 countries of the EU as well as Norway, Island and Liechtenstein.