NexoBrid - opinion on variation to marketing authorisation

Opinion

EMA has issued an opinion on a change to this medicine's authorisation.

concentrate of proteolytic enzymes enriched in bromelain

Opinion

On 09 November 2023, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending a change to the terms of the marketing authorisation for the medicinal product NexoBrid. The marketing authorisation holder for this medicinal product is MediWound Germany GmbH.

The CHMP adopted an extension to the existing indication. The full indication will be as follows:¹

NexoBrid is indicated in all age groups for removal of eschar in adultspatients with deep partial- and full-thickness thermal burns.

Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR), and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.

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¹New text in bold, removed text as strikethrough

CHMP post-authorisation summary of positive opinion for NexoBrid (II-58)

AdoptedReference Number: EMA/CHMP/480164/2023

Key facts

• Name of medicine:
  NexoBrid
• EMA product number:
  EMEA/H/C/002246
• Active substance:
  proteolytic enzymes enriched in bromelain
• International non-proprietary name (INN) or common name:
  concentrate of proteolytic enzymes enriched in bromelain
• Therapeutic area (MeSH):
  Debridement
• Anatomical therapeutical chemical (ATC) code:
  D03BA03
• Marketing authorisation holder:
  MediWound Germany GmbH
• Date of opinion:
  09/11/2023
• Status:
  Positive