🇪🇺 i.v. fentanyl and AeroLEF in European Union

EMA authorised i.v. fentanyl and AeroLEF on 24 January 2006

Marketing authorisations

EMA — authorised 24 January 2006

  • Application: EMEA/H/C/000612
  • Marketing authorisation holder: Janssen-Cilag International NV
  • Local brand name: Ionsys
  • Indication: Management of acute moderate to severe post-operative pain for use in a hospital setting only
  • Status: withdrawn

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EMA — authorised 18 November 2015

  • Application: EMEA/H/C/002715
  • Marketing authorisation holder: Incline Therapeutics Europe Ltd
  • Local brand name: Ionsys
  • Indication: Ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.
  • Status: withdrawn

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i.v. fentanyl and AeroLEF in other countries

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

Frequently asked questions

Is i.v. fentanyl and AeroLEF approved in European Union?

Yes. EMA authorised it on 24 January 2006; EMA authorised it on 18 November 2015.

Who is the marketing authorisation holder for i.v. fentanyl and AeroLEF in European Union?

Janssen-Cilag International NV holds the EU marketing authorisation.