NexoBrid

RSS

concentrate of proteolytic enzymes enriched in bromelain

Authorised
This medicine is authorised for use in the European Union.

Overview

This is a summary of the European public assessment report (EPAR) for NexoBrid. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for NexoBrid.

This EPAR was last updated on 26/04/2023

Authorisation details

Product details
Name
NexoBrid
Agency 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 therapeutic chemical (ATC) code
D03BA03
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
MediWound Germany GmbH
Revision
15
Date of issue of marketing authorisation valid throughout the European Union
18/12/2012
Contact address

MediWound Germany GmbH
Hans-Sachs-Strasse 100
65428 Rüsselsheim
Germany

Product information

30/03/2023 NexoBrid - EMEA/H/C/002246 - II/0057

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Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Preparations for treatment of wounds and ulcers

Therapeutic indication

NexoBrid is indicated for removal of eschar in adults with deep partial- and full-thickness thermal burns.

Assessment history

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