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 12/10/2018

Authorisation details

Product details
Name
NexoBrid
Agency product number
EMEA/H/C/002246
Active substance
concentrate of 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.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation

Publication details
Marketing-authorisation holder
MediWound Germany GmbH
Revision
8
Date of issue of marketing authorisation valid throughout the European Union
18/12/2012
Contact address
Eisenstrasse 5
65428 Rüsselsheim
Germany

Product information

28/09/2018 NexoBrid - EMEA/H/C/002246 - PSUSA/00010028/201712

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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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