Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Effentora   
Auth. number : EU/1/08/441
INN : fentanyl citrate
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: Effentora is indicated for the treatment of breakthrough pain (BTP) in adults with cancer who are already receiving maintenance opioid therapy for chronic cancer pain.
BTP 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: Teva Pharma B.V.
Computerweg 10, NL-3542 DR Utrecht, Nederland

  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
09/04/2008 Centralised - Authorisation EMEA/H/C/833 (2008)1351 of 04/04/2008
08/01/2009 Centralised - Variation EMEA/H/C/833/IA/2
03/06/2009 Centralised - Variation EMEA/H/C/833/N/6
Updated with Decision(2009)5327 of 29/06/2009
01/07/2009 Centralised - Variation EMEA/H/C/833/II/1 (2009)5327 of 29/06/2009
07/09/2009 Centralised - Variation EMEA/H/C/833/IA/7
17/09/2009 Centralised - Variation EMEA/H/C/833/IA/8
11/12/2009 Centralised - Variation EMEA/H/C/833/II/3 (2009)10235 of 10/12/2009
14/12/2009 Centralised - Variation EMEA/H/C/833/II/3 (2009)10233 of 10/12/2009
14/12/2009 Centralised - Variation EMEA/H/C/833/II/4, 5 (2009)10234 of 10/12/2009
28/01/2010 Centralised - Variation EMEA/H/C/833/IB/9
Updated with Decision(2010)1829 of 15/03/2010
22/03/2010 Centralised - Variation (2010)1829 of 15/03/2010
08/07/2010 Centralised - Variation EMEA/H/C/833/N/10
Updated with Decision(2010)7735 of 03/11/2010
25/08/2010 Centralised - Variation EMEA/H/C/833/IA/12/G
Updated with Decision(2010)7735 of 03/11/2010
26/08/2010 Centralised - Variation EMEA/H/C/833/IB/11/G
Updated with Decision(2010)7735 of 03/11/2010
09/11/2010 Centralised - Variation (2010)7735 of 03/11/2010
08/12/2010 Centralised - Variation EMEA/H/C/833/IA/13
24/11/2011 Centralised - Variation EMEA/H/C/833/II/14 (2011)8688 of 22/11/2011
05/06/2012 Centralised - Variation EMEA/H/C/833/N/17
Updated with Decision(2012)9943 of 20/12/2012
27/12/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/833/T/20 (2012)9943 of 20/12/2012
22/02/2013 Centralised - Renewal EMEA/H/C/833/R/19 (2013)1091 of 20/02/2013
24/06/2013 Centralised - Variation EMEA/H/C/833/IAin/24/G
Updated with Decision(2014)1478 of 28/02/2014
05/03/2014 Centralised - Modification EMEA/H/C/833/PSUSA/1369 (2014)1478 of 28/02/2014
20/03/2014 Centralised - Variation EMEA/H/C/833/II/20