🇪🇺 Sonata in European Union

EMA authorised Sonata on 12 March 1999

Marketing authorisation

EMA — authorised 12 March 1999

  • Application: EMEA/H/C/000227
  • Marketing authorisation holder: Meda AB
  • Local brand name: Sonata
  • Indication: Sonata is indicated for the treatment of patients with insomnia who have difficulty falling asleep. It is indicated only when the disorder is severe, disabling or subjecting the individual to extreme distress.
  • Status: withdrawn

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Sonata in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Neuroscience approved in European Union

Frequently asked questions

Is Sonata approved in European Union?

Yes. EMA authorised it on 12 March 1999.

Who is the marketing authorisation holder for Sonata in European Union?

Meda AB holds the EU marketing authorisation.