Pharmaceuticals - Community Register


Community register of medicinal products for human use


Product information

Invented name: PecFent   
Auth. number : EU/1/10/644
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: PecFent is indicated for the management of breakthrough pain (BTP) in adults who are 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 of oxycodone daily, at least 8 mg of oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.
Marketing Authorisation Holder: Archimedes Development Ltd
Albert Einstein Centre, Nottingham Science and Technology Park, University Boulevard NG7 2 TN Nottingham, United Kingdom
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
03/09/2010 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/1164 (2010)6110 of 31/08/2010
06/09/2010 Centralised - Authorisation EMEA/H/C/1164 (2010)6109 of 31/08/2010
10/12/2010 Centralised - Variation EMEA/H/C/1164/IB/1/G
Updated with Decision(2011)4295 of 14/06/2011
10/12/2010 Centralised - Variation EMEA/H/C/1164/IB/2
Updated with Decision(2011)4295 of 14/06/2011
03/01/2011 Centralised - Notification EMEA/H/C/1164/N/3
Updated with Decision(2011)4295 of 14/06/2011
12/05/2011 Centralised - Variation EMEA/H/C/1164/IA/4/G
Updated with Decision(2011)4295 of 14/06/2011
16/06/2011 Centralised - Variation (2011)4295 of 14/06/2011
24/11/2011 Centralised - Variation EMEA/H/C/1164/II/5 (2011)8683 of 22/11/2011
19/06/2012 Centralised - Notification EMEA/H/C/1164/N/11
Updated with Decision(2012)6851 of 24/09/2012
27/09/2012 Referral EMEA/H/C/1164/A-20/13 (2012)6851 of 24/09/2012
26/10/2012 Centralised - Variation EMEA/H/C/1164/IB/14
Updated with Decision(2012)7989 of 31/10/2012
06/11/2012 Centralised - Variation (2012)7989 of 31/10/2012
04/03/2014 PSUSA - Modification EMEA/H/C/1164/PSUSA/1369 (2014)1473 of 28/02/2014
02/06/2014 Centralised - Variation EMEA/H/C/1164/IB/27
Updated with Decision(2015)2322 of 30/03/2015
01/04/2015 PSUSA - Modification EMEA/H/C/1164/PSUSA/1369/201404 (2015)2322 of 30/03/2015
21/07/2015 Centralised - Renewal EMEA/H/C/1164/R/32 (2015)5142 of 17/07/2015
30/07/2015 Rectificative Decision (2015)5468 of 28/07/2015
16/11/2015 Centralised - Notification EMEA/H/C/1164/N/35
Updated with Decision(2017)3948 of 02/06/2017
16/06/2016 Centralised - Variation EMEA/H/C/1164/IB/37
Updated with Decision(2017)3948 of 02/06/2017
15/08/2016 Centralised - Notification EMEA/H/C/1164/N/39
Updated with Decision(2017)3948 of 02/06/2017
24/11/2016 Centralised - Notification EMEA/H/C/1164/N/40
Updated with Decision(2017)3948 of 02/06/2017
25/04/2017 Centralised - Notification EMEA/H/C/1164/N/42
Updated with Decision(2017)3948 of 02/06/2017
07/06/2017 Centralised - Yearly update (2017)3948 of 02/06/2017
18/01/2018 Centralised - Variation EMEA/H/C/1164/IAIN/45