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Naloxone

Nyxoid · ATC code V03AB15

Also known as: Naloxon, Nalokson, Naloxona · Brand names: Nyxoid, Naloxon Accord, Naloxon B. Braun, Naloxon Hameln, Naloxon Inresa, Naloxon-Ratiopharm, Ventizolve, Forvel, Naloxon Amomed, Nalokson Hidroklorur

Key facts
Active substance
Naloxone
Drug class
Antidote
ATC code
V03AB15
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Nyxoid 1.8 mg nasal spray, solution in single-dose container
Marketing authorisation holder
Mundipharma Corporation (Ireland) Limited
Information as of
2026-11-03

Key facts

Naloxone is a competitive opioid receptor antagonist. This page covers Nyxoid, the EU nasal spray (1.8 mg single-dose container) for emergency treatment of known or suspected opioid overdose by lay people or healthcare staff, in adults and adolescents aged 14 years and over.

What it is used for

  • Emergency therapy of known or suspected opioid overdose with respiratory and/or CNS depression, in non-medical and healthcare settings
  • Adults and adolescents aged 14 years and over; not a substitute for emergency medical care

Dosing

  • 1.8 mg into one nostril (one nasal spray), as soon as possible
  • No response: second dose after 2-3 minutes; relapse into respiratory depression after an initial response: second dose immediately
  • Further doses in alternate nostrils while monitoring the patient until emergency services arrive
  • Single-dose device: do not prime or test before use
  • Not established in children below 14 years

Contraindications

  • Hypersensitivity to naloxone or any excipient

Important warnings

  • Supply only after the user has been instructed in proper use and in the importance of calling for medical help
  • Some opioids act longer than naloxone: monitor closely, respiratory depression may recur and further doses may be needed
  • Rapid reversal can cause acute opioid withdrawal; patients on opioids for chronic pain may experience pain
  • Reversal of buprenorphine-induced respiratory depression may be incomplete (assist ventilation); absorption may be altered with damaged nasal mucosa
  • Opioid withdrawal in neonates may be life-threatening (convulsions, excessive crying, hyperactive reflexes)
  • No driving or operating machinery for at least 24 hours after use

Side effects

  • Very common: nausea
  • Common: vomiting, dizziness, headache, tachycardia, hypotension, hypertension
  • Opioid withdrawal syndrome in dependent patients (restlessness, irritability, muscle spasms, tachycardia, increased blood pressure, yawning, pyrexia, aggression)
  • Very rare: anaphylactic shock, cardiac fibrillation, cardiac arrest, pulmonary oedema

Interactions

  • Opioids: reverses their effect, including analgesia; in opioid-dependent patients acute withdrawal with hypertension, arrhythmias, pulmonary oedema or cardiac arrest (more typical post-operatively)
  • Buprenorphine: analgesia may be restored, but reversal of respiratory depression is limited

Pregnancy and breastfeeding

  • Use in pregnancy only if the woman's clinical condition requires naloxone; monitor the fetus for distress; may cause withdrawal in newborns of opioid-dependent mothers
  • Breast-feeding need not be discontinued (negligible oral bioavailability); monitor the infant for sedation or irritability

Summary of the official product information, written with AI on 2026-11-03. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • NyxoidMundipharma Corporation (Ireland) Limited · EMEA/H/C/004325

Source: European Medicines Agency (EMA), product information

Germany

  • Naloxon AccordAccord Healthcare B.V. · 1 register entry
  • Naloxon B. BraunB.Braun Melsungen Ag · 1 register entry
  • Naloxon HamelnHameln Pharma Gmbh · 1 register entry
  • Naloxon InresaInresa Arzneimittel Gmbh · 1 register entry
  • Naloxon-RatiopharmRatiopharm Gmbh · 1 register entry
  • VentizolveNavamedic Asa · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-11-03

Austria

  • ForvelMedochemie Ltd. · 1 register entry
  • Naloxon AccordAccord Healthcare B.V. · 1 register entry
  • Naloxon AmomedAmomed Pharma Gmbh · 1 register entry
  • Naloxon B. BraunB.Braun Melsungen Ag · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-11-03

Turkey

  • Nalokson HidroklorurMEDİTERA İTH. İHR. LTD. ŞTİ. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-11-03

Brand names in 28 more European countries
Belgium
Naloxon B. Braun, Ventizolve
Bulgaria
Форвел
Croatia
Forvel
Cyprus
Codaxol, Forvel
Czechia
Forvel, Naloxone Polpharma
Denmark
Forvel, Naloxon B. Braun, Naloxon Hameln, Naloxone Accord, Prenoxad, Ventizolve
Estonia
Forvel, Ventizolve
Finland
Naloxone Accord, Nexodal, Ventizolve
France
Naloxone Accord, Naloxone Adapt Pharma, Prenoxad, Ventizolve
Greece
Forvel, Νaloxon B.Braun
Hungary
Nexodal
Iceland
Naloxon B. Braun, Nyxoid, Ventizolve
Ireland
Naloxone Hydrochloride Accord, Naloxone Hydrochloride Mercury Pharmaceuticals (Ireland), Prenoxad, Ventizolve
Italy
Naloxone Accord, Naloxone Adapt, Naloxone B. Braun, Naloxone Cloridrato Adulti Galenica Senese, Naloxone Cloridrato Adulti Molteni, Naloxone Cloridrato Adulti S.A.L.F., Naloxone Cloridrato Bambini Galenica Senese, Naloxone Cloridrato Bambini Molteni, Naloxone Cloridrato Bambini S.A.L.F., Ventizolve
Latvia
Forvel
Liechtenstein
Nyxoid
Lithuania
Forvel
Luxembourg
Naloxon B. Braun
Malta
Forvel
Netherlands
Naloxon Hci B. Braun, Naloxon Hcl Accord, Naloxon Hcl Hameln, Naloxon Orpha, Ventizolve
Norway
Naloxon B. Braun, Naloxon Hameln, Naloxone Accord, Nyxoid, Ventizolve
Poland
Naloxonum Hydrochloricum Wzf
Portugal
Forvel, Naloxona Accord, Naloxona B. Braun, Naxan
Romania
Forvel
Slovakia
Naloxone Polpharma
Slovenia
Nexodal
Spain
Fomed, Naloxona B. Braun, Naloxona Kern Pharma
Sweden
Naloxon Actrevo, Naloxon Hameln, Naloxone Accord, Prenoxad, Respinal

EMA – Article 57 product data (EU/EEA), 2026-11-03

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Nyxoid – EPAR, Product Information. 2026-11-03. https://www.ema.europa.eu/en/documents/product-information/nyxoid-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-11-03. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-11-03. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-11-03. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC V03AB.

Editorial: Medelix editorial team · last updated 2026-11-03 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.