Ionsys

Withdrawn

This medicine's authorisation has been withdrawn

fentanyl

Overview

The marketing authorisation for Ionsys has been withdrawn at the request of the marketing-authorisation holder.

 

Ionsys : EPAR - Medicine overview

Reference Number: EMA/639971/2015

Ionsys : EPAR - Risk-management-plan summary

Product information

Ionsys : EPAR - Product Information

Latest procedure affecting product information: --

26/10/2018

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:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Ionsys : EPAR - All Authorised presentations

Product details

• Name of medicine:
  Ionsys
• Active substance:
  fentanyl hydrochloride
• International non-proprietary name (INN) or common name:
  fentanyl
• Therapeutic area (MeSH):
  Pain, Postoperative
• Anatomical therapeutic chemical (ATC) code:
  N02AB03

Pharmacotherapeutic group

Analgesics

Therapeutic indication

Ionsys is indicated for the management of acute moderate to severe post-operative pain in adult patients.

Authorisation details

• EMA product number:
  EMEA/H/C/002715
• Marketing authorisation holder:
  Incline Therapeutics Europe Ltd

  21 St Thomas Street ; Bristol ; BS1 6JS; United Kingdom

• Opinion adopted:
  23/09/2015
• Marketing authorisation issued:
  18/11/2015
• Revision:
  2

Assessment history

Changes since initial authorisation of medicine

Ionsys-H-C-2715-P46-003.1 : EPAR - Assessment Report

AdoptedReference Number: EMA/78915/2018

Initial marketing authorisation documents

Ionsys : EPAR - Public assessment report

AdoptedReference Number: EMA/801150/2015

CHMP summary of positive opinion for Ionsys

AdoptedReference Number: EMA/CHMP/588247/2015