PolyPid Ltd. announced that it has received confirmation from the European Medicines Agency (EMA) that D-PLEX100 is eligible for submission of a Marketing Authorization Application (MAA) in the European Union (EU) under the Agency's centralized procedure. The centralized procedure allows the submission of a single marketing application to the EMA that, if approved, enables the product to be marketed in all EU member states as well as in Iceland, Liechtenstein and Norway. The centralized process eligibility is granted to D-PLEX100 under the Therapeutic Innovation criteria which underscores that D-PLEX100 provides a new alternative to patients in preventing post abdominal surgical site infections (SSIs).
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- Polypid Ltd. Announces Eligibility for European Medicines Agency Centralized Procedure for D-Plex100 for the Prevention of Surgical Site Infections in Abdominal Surgery