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GaldermaOpensupNewChapterforSculptrawithMDRCertificationandNewExpandedIndicationforBody
===2025/12/5 15:03:37===
reinforcing Galderma’s commitment to innovation and holistic patient care.”



FLEMMING ØRNSKOV, M.D., MPH

CHIEF EXECUTIVE OFFICER

GALDERMA














The broadest aesthetics portfolio backed by science, reinforcing Galderma’s commitment to continuous innovation and regulatory excellence

The EU MDR certification is part of Galderma’s broader MDR transition strategy, which encompasses its full portfolio of aesthetic injectables, such as its Restylane®hyaluronic acid injectables, and dermatological devices. It confirms that Sculptra meets the highest standards of safety, performance, and quality under the updated regulatory framework. While this milestone supports Sculptra’s certification for body indications, it also reinforces Galderma’s broader c
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