European Commission authorizes EU-wide marketing and distribution of Biofrontera's Ameluz
Ameluz® is a prescription-only medicinal product for the treatment of actinic keratosis by the so-called photodynamic therapy. In such therapies a medicinal product, in this case Ameluz®, is combined with a light-treatment. Large pivotal clinical trials had demonstrated the strong superiority of Ameluz® in comparison to its competitors. With the EU-wide approval, Ameluz® can in principle be distributed immediately, but the manufacturing and the release of Ameluz® will still require some weeks. The first market launch, planned for Germany, is thus foreseen for the 1st of February.
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