EMA Provides Regulatory Path for MediWound's (MDWD) NexoBrid
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EMA Provides Regulatory Path for Pediatric Label Extension for NexoBrid
November 18, 2021 7:30 AM ESTAnticipate Submission for Label Extension in First Half 2022
YAVNE, Israel, Nov. 18, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (Nasdaq: MDWD) (the Company), a fully-integrated biopharmaceutical company focused on next-generation biotherapeutic solutions for tissue repair and regeneration, today announced that the Company has received positive scientific advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the pediatric label extension for NexoBrid. Based on the feedback, the Company anticipates submitting a pediatric label extension request in the first half of 2022.
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