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||
15/09/2022 Nyxoid - EMEA/H/C/004325 - R/0014
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.
All other therapeutic products
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.