Basic Information
Nyxoid
Regulatory Information
EMEA/H/C/004325
November 9, 2017
9
February 24, 2023
Company Information
Ireland
United Drug House Magna Drive Magna Business Park Citywest Road Dublin 24
MUNDIPHARMA CORPORATION (IRELAND) LIMITED
Active Substances Detail
Naloxone hydrochloride dihydrate
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
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.