Nyxoid

RSS

naloxone

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

Overview

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.

This EPAR was last updated on 05/02/2018

Authorisation details

Product details
Name
Nyxoid
Agency product number
EMEA/H/C/004325
Active substance
Naloxone hydrochloride dihydrate
International non-proprietary name (INN) or common name
naloxone
Therapeutic area (MeSH)
Opioid-Related Disorders
Anatomical therapeutic chemical (ATC) code
V03AB15
Publication details
Marketing-authorisation holder
Mundipharma Corporation Limited
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
10/11/2017
Contact address
Milton Road
Cambridge Science Park
Cambridge CB4 0AB
United Kingdom

Product information

10/01/2018 Nyxoid - EMEA/H/C/004325 - IB/0001

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

ALL OTHER THERAPEUTIC PRODUCTS

Therapeutic indication

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.

Assessment history

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