Instanyl

RSS

fentanyl

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

Overview

This is a summary of the European public assessment report (EPAR) for Instanyl. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Instanyl.

This EPAR was last updated on 12/06/2018

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
20
Date of issue of marketing authorisation valid throughout the European Union
20/07/2009
Contact address
Langebjerg 1
DK-4000 Roskilde
Denmark

Product information

08/05/2018 Instanyl - EMEA/H/C/000959 - PSUSA/00001369/201704

Contents

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You are therefore advised to be selective about which sections or pages you wish to print.

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

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