This medicine is authorised for use in the European Union.


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 17/01/2023

Authorisation details

Product details
Agency product number
Active substance
Fentanyl citrate
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Pain
  • Cancer
Anatomical therapeutic chemical (ATC) code
Publication details
Marketing-authorisation holder
Takeda Pharma A/S
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Delta Park 45
2665 Vallensbaek Strand

Product information

16/01/2023 Instanyl - EMEA/H/C/000959 - IB/0074

Other EU languages available icon This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.


Product information documents contain:

You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group


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

How useful was this page?

Add your rating
4 ratings
1 rating
1 rating