This is a summary of the European public assessment report (EPAR) for Nyxoid. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Nyxoid.
For practical information about using Nyxoid, patients should read the package leaflet or contact their doctor or pharmacist.
Nyxoid : EPAR - Summary for the public (PDF/74.61 KB)
First published: 12/12/2017
Last updated: 12/12/2017
|Agency product number||
Naloxone hydrochloride dihydrate
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Mundipharma Corporation (Ireland) Limited
|Date of issue of marketing authorisation valid throughout the European Union||
05/04/2019 Nyxoid - EMEA/H/C/004325 - IAIN/0006
- 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.
Nyxoid is intended for immediate administration as emergency therapy for known or suspected opioid overdose as manifested by respiratory and/or central nervous system depression in both non-medical and healthcare settings.
Nyxoid is indicated in adults and adolescents aged 14 years and over.
Nyxoid is not a substitute for emergency medical care.