Pharmaceuticals - Community Register


Community list of not active medicinal products for human use


Product information

Invented name: Ionsys
Auth. number : EU/1/05/326
INN : Fentanyl
ATC: Anatomical main group: N - Nervous system
Therapeutic subgroup: N02 - Analgesics
Pharmacological subgroup: N02A - Opioids
Chemical subgroup: N02AB - Phenylpiperidine derivatives
Chemical substance: N02AB03 - Fentanyl
(See WHO ATC Index)
Indication: IONSYS is indicated for the management of acute moderate to severe post-operative pain for use in a hospital setting only
Marketing Authorisation Holder: Janssen-Cilag International NV
Turnhoutseweg 30, B-2340 Beerse, België

  EPAR and active package presentations

Package presentations

Information about presentations can be found in the website of the European Medicines Agency under the section "Product Information".
Likewise, presentations on which there has been a Commission decision are referred in the Summary of Product Characteristics (Annex I to the Commission Decision granting the marketing authorisation) which is available in the Community Register.


European Commission proceduresGoto top of the page

Close date procedure Procedure type EMEA number Decision summary publ decision docs annex
25/01/2006 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/612 (2006)194 of 24/01/2006
26/01/2006 Centralised - Authorisation EMEA/H/C/612 (2006)195 of 24/01/2006
28/06/2007 Centralised - Variation EMEA/H/C/612/IA/1, 2, 3
17/07/2007 Centralised - Variation EMEA/H/C/612/IB/5
14/08/2007 Centralised - Variation EMEA/H/C/612/IB/4
17/08/2007 Centralised - Variation EMEA/H/C/612/IA/6
Updated with Decision(2007)5147 of 15/10/2007
18/10/2007 Centralised - Variation EMEA/H/C/612/II/8 (2007)5147 of 15/10/2007
26/11/2007 Centralised - Variation EMEA/H/C/612/II/7 (2007)5781 of 21/11/2007
03/06/2008 Centralised - Variation EMEA/H/C/612/IB/9
18/07/2008 Centralised - Variation EMEA/H/C/612/IA/11
18/07/2008 Centralised - Variation EMEA/H/C/612/IA/12
06/08/2008 Centralised - Variation EMEA/H/C/612/IB/10
20/01/2009 Referral EMEA/H/C/612/A-20/13 (2009)238 of 16/01/2009
24/01/2011 Centralised - Withdrawal