NexoBrid
concentrate of proteolytic enzymes enriched in bromelain
Table of contents
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.
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NexoBrid : EPAR - Summary for the public (PDF/58.09 KB)
First published: 07/01/2013
Last updated: 07/01/2013
EMA/628522/2012 -
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NexoBrid : EPAR - Risk-management-plan summary (PDF/131.55 KB)
First published: 03/11/2020
Last updated: 26/04/2023
Authorisation details
Product details | |
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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 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 | |
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Marketing-authorisation holder |
MediWound Germany GmbH
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Revision |
15
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Date of issue of marketing authorisation valid throughout the European Union |
18/12/2012
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Contact address |
MediWound Germany GmbH |
Product information
30/03/2023 NexoBrid - EMEA/H/C/002246 - II/0057
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
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.