🇪🇺 Intranasal Fentanyl in European Union

EMA authorised Intranasal Fentanyl on 20 July 2009

Marketing authorisation

EMA — authorised 20 July 2009

  • Application: EMEA/H/C/000959
  • Marketing authorisation holder: Istituto Gentili S.r.l.
  • Local brand name: Instanyl
  • Indication: Instanyl is indicated for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Breakthrough pain is a transitory exacerbation of pain that occurs on a background of otherwise controlled persistent pain.  Patients receiving maintenance opioid therapy are those who are taking at least 60 mg of oral morphine daily, at least 25 micrograms of transdermal fentanyl per hour, at least 30 mg oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
  • Status: approved

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Intranasal Fentanyl 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 Intranasal Fentanyl approved in European Union?

Yes. EMA authorised it on 20 July 2009.

Who is the marketing authorisation holder for Intranasal Fentanyl in European Union?

Istituto Gentili S.r.l. holds the EU marketing authorisation.