Ionsys

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fentanyl

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for this product has not been renewed by the marketing authorisation holder and is now withdrawn

This EPAR was last updated on 28/01/2011

Authorisation details

Product details
Name
Ionsys
Agency product number
EMEA/H/C/000612
Active substance
fentanyl hydrochloride
International non-proprietary name (INN) or common name
fentanyl
Therapeutic area (MeSH)
Pain, Postoperative
Anatomical therapeutic chemical (ATC) code
N02AB03
Publication details
Marketing-authorisation holder
Janssen-Cilag International NV
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
24/01/2006
Contact address

Turnhoutseweg, 30
B-2340 Beerse
Belgium

Product information

24/01/2011 Ionsys - EMEA/H/C/000612 - A20-0013

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).

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

Analgesics

Therapeutic indication

Management of acute moderate to severe post-operative pain for use in a hospital setting only

Assessment history

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