Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Intelence   
Auth. number : EU/1/08/468
INN : etravirine
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J05 - Antivirals for systemic use
Pharmacological subgroup: J05A - Agents affecting the virus directly
Chemical subgroup: J05AG - Non-nucleoside reverse transcriptase inhibitors
Chemical substance: J05AG04 - Etravirine
(See WHO ATC Index)
Indication: INTELENCE, in combination with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of human immunodeficiency virus type 1 (HIV 1) infection in antiretroviral treatment experienced adult patients and in antiretroviral treatment experienced paediatric patients from 6 years of age.

The indication in adults is based on week 48 analyses from 2 Phase III trials in highly pre treated patients where INTELENCE was investigated in combination with an optimised background regimen (OBR) which included darunavir/ritonavir. The indication in paediatric patients is based on 48 week analyses of a single arm, Phase II trial in antiretroviral treatment experienced paediatric patients.
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
01/09/2008 Centralised - Authorisation EMEA/H/C/900 (2008)4744 of 28/08/2008
28/04/2009 Centralised - Variation EMEA/H/C/900/II/1, 2 (2009)3260 of 23/04/2009
05/08/2009 Centralised - Annual renewal EMEA/H/C/900/R/3 (2009)6252 of 03/08/2009
06/11/2009 Centralised - Variation EMEA/H/C/900/II/6 (2009)8666 of 04/11/2009
17/11/2009 Centralised - Variation EMEA/H/C/900/II/7 (2009)9056 of 12/11/2009
01/12/2009 Centralised - Variation EMEA/H/C/900/II/4 (2009)9597 of 27/11/2009
17/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/900/IA/10
01/04/2010 Centralised - Variation EMEA/H/C/900/II/8 (2010)2248 of 30/03/2010
03/05/2010 Centralised - Variation EMEA/H/C/900/II/5 (2010)2929 of 29/04/2010
07/07/2010 Centralised - Annual renewal EMEA/H/C/900/R/9 (2010)4712 of 02/07/2010
21/07/2010 Centralised - Variation EMEA/H/C/900/IA/11
Updated with Decision(2010)8661 of 29/11/2010
22/09/2010 Centralised - Variation EMEA/H/C/900/IG/23/G
Updated with Decision(2010)8661 of 29/11/2010
02/12/2010 Centralised - Variation (2010)8661 of 29/11/2010
02/12/2010 Centralised - Annual renewal EMEA/H/C/900/R/9 (2010)4712 of 02/07/2010
31/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/900/II/13
25/07/2011 Centralised - Annual renewal EMEA/H/C/900/R/15 (2011)5395 of 20/07/2011
30/08/2011 Centralised - Variation EMEA/H/C/900/II/14 (2011)6159 of 24/08/2011
29/11/2011 Centralised - Variation EMEA/H/C/900/X/12 (2011)8859 of 24/11/2011
21/03/2012 Centralised - Variation EMEA/H/C/900/II/20 (2012)1915 of 19/03/2012
24/07/2012 Centralised - Annual renewal EMEA/H/C/900/R/23 (2012)5282 of 20/07/2012
21/02/2013 Centralised - Variation EMEA/H/C/900/II/27
Updated with Decision(2013)4020 of 21/06/2013
08/03/2013 Centralised - Variation EMEA/H/C/900/II/24/G, EMEA/H/C/900/X/18/G (2013)1417 of 06/03/2013
25/06/2013 Centralised - Annual renewal EMEA/H/C/900/R/28 (2013)4020 of 21/06/2013
03/07/2013 Centralised - 2-Monthly update EMEA/H/C/900/WS/396 (2013)4242 of 01/07/2013
22/11/2013 Centralised - Authorisation - Switch to non-conditional EMEA/H/C/900/II/31 (2013)8339 of 20/11/2013
10/01/2014 Centralised - Modification EMEA/H/C/900/PSUV/33 (2014)76 of 08/01/2014
20/03/2014 Centralised - Variation EMEA/H/C/900/WS/507
25/04/2014 Centralised - Variation EMEA/H/C/900/IB/37
22/05/2014 Centralised - Variation EMEA/H/C/900/II/36