Nyxoid (naloxone)
- Region
- 🇪🇺 EU
- Active substance
- naloxone
- Company
- Mundipharma Corporation (Ireland) Limited
- Status
- Authorised
- Therapeutic area
- Opiate Overdose
- EU approval
- Thu 09 Nov 2017
- Application
- EMEA/H/C/004325
- ATC
- V03AB15
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Suboxone Withdrawn · Indivior Europe Limited
- 🇪🇺 Zubsolv Authorised · Accord Healthcare S.L.U.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.