Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Instanyl   
Auth. number : EU/1/09/531
Active substance : 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: 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.
Marketing Authorisation Holder: Takeda Pharma A/S
Dybendal Alle 10, 2630 Taastrup, Danmark
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
23/07/2009 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/959 (2009)5901 of 20/07/2009
23/07/2009 Centralised - Authorisation EMEA/H/C/959 (2009)5900 of 20/07/2009
02/12/2009 Centralised - Notification EMEA/H/C/959/N/1
Updated with Decision(2011)4837 of 29/06/2011
04/07/2011 Centralised - Variation - Decision addressed to Member States EMEA/H/C/959/X/2 (2011)4836 of 29/06/2011
05/07/2011 Centralised - Variation EMEA/H/C/959/X/2 (2011)4837 of 29/06/2011
20/07/2011 Centralised - Variation EMEA/H/C/959/IB/4
Updated with Decision(2012)1381 of 27/02/2012
09/08/2011 Centralised - Variation EMEA/H/C/959/IB/7/G
Updated with Decision(2012)1381 of 27/02/2012
01/12/2011 Centralised - Notification EMEA/H/C/959/N/8
Updated with Decision(2012)1381 of 27/02/2012
29/02/2012 Centralised - Variation (2012)1381 of 27/02/2012
09/08/2012 Centralised - Variation EMEA/H/C/959/IB/9/G
Updated with Decision(2012)7731 of 25/10/2012
29/10/2012 Centralised - Variation (2012)7731 of 25/10/2012
22/03/2013 Centralised - Variation EMEA/H/C/959/II/12
Updated with Decision(2014)1477 of 28/02/2014
19/07/2013 Centralised - Notification EMEA/H/C/959/N/14
Updated with Decision(2014)1477 of 28/02/2014
24/07/2013 Centralised - Variation EMEA/H/C/959/IAin/18/G
Updated with Decision(2014)1477 of 28/02/2014
18/10/2013 Centralised - Variation EMEA/H/C/959/IAin/21/G
Updated with Decision(2014)1477 of 28/02/2014
04/03/2014 PSUSA - Modification EMEA/H/C/959/PSUSA/1369 (2014)1477 of 28/02/2014
25/04/2014 Centralised - Renewal EMEA/H/C/959/R/22 (2014)2811 of 23/04/2014
22/09/2014 Centralised - Variation EMEA/H/C/959/IAin/29/G
Updated with Decision(2015)1570 of 05/03/2015
07/11/2014 Centralised - Variation EMEA/H/C/959/IAin/31
Updated with Decision(2015)1570 of 05/03/2015
23/01/2015 Centralised - Notification EMEA/H/C/959/N/32
Updated with Decision(2016) 6241 of 22/09/2016
09/03/2015 PSUSA - Modification EMEA/H/C/959/PSUSA/1369/201404 (2015)1570 of 05/03/2015
30/07/2015 Rectificative Decision (2015)5472 of 28/07/2015
17/09/2015 Centralised - Variation EMEA/H/C/959/IB/36
Updated with Decision(2016) 6241 of 22/09/2016
18/02/2016 Centralised - Variation EMEA/H/C/959/IB/37
Updated with Decision(2016) 6241 of 22/09/2016
01/04/2016 Centralised - Variation EMEA/H/C/959/X/30/G
Updated with Decision(2016) 6241 of 22/09/2016