Instanyl

RSS

fentanyl

Authorised
This medicine is authorised for use in the European Union.

Overview

Instanyl is a medicine used to treat breakthrough pain in adults with cancer. Breakthrough pain is when a patient experiences additional, sudden pain in spite of ongoing treatment with painkillers. Instanyl is used in patients who are already using opioids (a group of painkillers that includes morphine and fentanyl) to control long-term cancer pain.

Instanyl contains the active substance fentanyl.

This EPAR was last updated on 21/11/2019

Authorisation details

Product details
Name
Instanyl
Agency product number
EMEA/H/C/000959
Active substance
Fentanyl citrate
International non-proprietary name (INN) or common name
fentanyl
Therapeutic area (MeSH)
  • Pain
  • Cancer
Anatomical therapeutic chemical (ATC) code
N02AB03
Publication details
Marketing-authorisation holder
Takeda Pharma A/S
Revision
22
Date of issue of marketing authorisation valid throughout the European Union
20/07/2009
Contact address
Langebjerg 1
DK-4000 Roskilde
Denmark

Product information

10/10/2019 Instanyl - EMEA/H/C/000959 - II/0051

Contents

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Pharmacotherapeutic group

ANALGESICS

Therapeutic 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.

Assessment history

Changes since initial authorisation of medicine

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