Evolus receives nod from EU for hyaluronic acid injectables, anticipates US approval

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Four hyaluronic acid injectables used as dermal fillers have received EU Medical Device Regulation certification, allowing them to be commercially available in the European Union. Branded as Estyme in the EU and Evolysse in the U.S., the products will be launched to select physicians in Europe through a limited experience program, with a larger European launch planned for the second half of 2025. The certification reflects the company’s commitment to delivering high-quality products that meet rigorous regulatory standards. The company expects U.S. approval and launch in early 2025. This milestone signifies the expansion of the company’s product portfolio to meet consumer demand for premium aesthetic treatments.

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