🇪🇺 Sufentanil Sublingual Tablet System in European Union

EMA authorised Sufentanil Sublingual Tablet System on 18 September 2015

Marketing authorisation

EMA — authorised 18 September 2015

  • Application: EMEA/H/C/002784
  • Marketing authorisation holder: FGK Representative Service GmbH
  • Local brand name: Zalviso
  • Indication: Zalviso is indicated for the management of acute moderate to severe post-operative pain in adult patients.
  • Status: withdrawn

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Other Pain Management approved in European Union

Frequently asked questions

Is Sufentanil Sublingual Tablet System approved in European Union?

Yes. EMA authorised it on 18 September 2015.

Who is the marketing authorisation holder for Sufentanil Sublingual Tablet System in European Union?

FGK Representative Service GmbH holds the EU marketing authorisation.