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esketamine

Spravato · ATC code N06AX27

Also known as: Esketamin · Brand names: Spravato, Escetex, Eskelan, Esketamin Kalceks, Esketamin Sintetica, Esketiv, Ketanest S, Esketex

Key facts
Active substance
esketamine
Drug class
Antidepressant
ATC code
N06AX27
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Spravato 28 mg nasal spray, solution
Marketing authorisation holder
Janssen-Cilag International NV
Information as of
2026-10-27

Key facts

Esketamine is an NMDA receptor antagonist given as a nasal spray. It is used for treatment-resistant major depressive disorder and as acute short-term treatment of depressive episodes that constitute a psychiatric emergency.

What it is used for

  • Treatment-resistant major depressive disorder in adults who have not responded to at least two different antidepressants in the current episode, combined with an SSRI or SNRI
  • Acute short-term treatment of a moderate to severe depressive episode constituting a psychiatric emergency, with oral antidepressant therapy

Dosing

  • Prescribed by a psychiatrist; self-administered under direct supervision of a healthcare professional, followed by an observation period
  • Treatment-resistant depression, adults under 65 years: day 1 56 mg; weeks 1–4 56 mg or 84 mg twice a week; weeks 5–8 once weekly; from week 9 every 2 weeks or once weekly
  • Adults 65 years and older: starting dose 28 mg, with dose changes in 28 mg increments
  • Check blood pressure before dosing and at approximately 40 minutes after
  • Dosing for acute short-term treatment is in the full text

Contraindications

  • Hypersensitivity to esketamine, ketamine or excipients
  • Aneurysmal vascular disease; history of intracerebral haemorrhage
  • Cardiovascular event including myocardial infarction within the last 6 weeks

Important warnings

  • Suicidal thoughts and clinical worsening: close supervision, especially early and after dose changes
  • Sedation, dissociation and elevated blood pressure: monitor until clinically stable
  • Unstable cardiovascular or respiratory conditions: administer only where resuscitation equipment and trained staff are available
  • Neuropsychiatric and motor impairments

Side effects

  • Most common: dizziness (31%), dissociation (27%), nausea (27%), headache (23%), somnolence, dysgeusia, vertigo, hypoaesthesia, vomiting, blood pressure increased (10%)
  • Common: anxiety, euphoric mood, confusional state, derealisation, hallucination

Interactions

  • CNS depressants (benzodiazepines, opioids, alcohol): increased sedation
  • Psychostimulants, xanthine derivatives, thyroid hormones, vasopressin, MAOIs: monitor blood pressure closely

Pregnancy and breastfeeding

  • Not recommended during pregnancy or in women of childbearing potential not using contraception; ketamine caused foetal neurotoxicity in animals
  • If pregnancy occurs, treatment should be discontinued

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

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)

  • SpravatoJanssen-Cilag International NV · EMEA/H/C/004535

Source: European Medicines Agency (EMA), product information

Austria

  • EscetexKalceks · 1 register entry
  • EskelanG.L. Pharma Gmbh · 1 register entry
  • Esketamin KalceksKalceks · 1 register entry
  • Esketamin SinteticaSintetica Gmbh · 1 register entry
  • EsketivEurocept International Bv · 1 register entry
  • Ketanest SPfizer Corporation Austria Ges.M.B.H. · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • EsketaminInresa Arzneimittel Gmbh, Sintetica Gmbh · 3 register entries
  • EsketexKalceks · 1 register entry
  • EsketivEurocept International Bv · 1 register entry
  • Ketanest SPfizer Pharma Gmbh · 2 register entries

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • SpravatoJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE TİC. LTD. ŞTİ. · 3 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 14 more European countries
Belgium
Esketamine Kalceks, Vesierra
Croatia
Esgamda
Denmark
Esketamine Orifarm, S-Ketamin Pfizer
Estonia
Esketex
Finland
Esketamine Kalceks, Esketamine Orifarm, Ketanest-S, Sinmelan
France
Eskesia, Esketamine Renaudin
Iceland
S-Ketamin Pfizer, Spravato
Latvia
Esketamine Kalceks
Liechtenstein
Spravato
Luxembourg
Vesierra
Netherlands
Esketamine Focus Care, Esketamine Idd, Esketamine Kalceks, Esketiv, Ketanest-S
Norway
Ketanest, Sinmelan, Spravato
Slovenia
Esketamin Kalceks, Sinmelan
Sweden
Esketamine Kalceks, Esketamine Orifarm, Ketanest, Sinmelan

EMA – Article 57 product data (EU/EEA), 2026-10-28

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

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Sources

  1. European Medicines Agency. Spravato – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/spravato-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. 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), 2026-10-28. 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, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  5. Wikidata (CC0): ATC N06AX.

Editorial: Medelix editorial team · last updated 2026-10-27 · 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.