Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Truvada   
Auth. number : EU/1/04/305
INN : emtricitabine / tenofovir disoproxil fumarate
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: J05AR - Antivirals for treatment of hiv infections, combinations
Chemical substance: J05AR03 - Tenofovir disoproxil and emtricitabine
(See WHO ATC Index)
Indication: Indicated in antiretroviral combination therapy for the treatment of HIV 1 infected adults aged 18 years and over.
The demonstration of the benefit of the combination emtricitabine and tenofovir disoproxil fumarate in antiretroviral therapy is based solely on studies performed in treatment naïve patients.
Marketing Authorisation Holder: Gilead Sciences International Limited
Cambridge CB21 6GT, 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
24/02/2005 Centralised - Authorisation EMEA/H/C/594 (2005)456 of 21/02/2005
06/04/2005 Centralised - Variation EMEA/H/C/594/IA/1
28/06/2005 Centralised - Variation EMEA/H/C/594/II/2
03/08/2005 Centralised - Variation EMEA/H/C/594/IB/4
30/08/2005 Centralised - Variation EMEA/H/C/594/IA/8
19/09/2005 Centralised - Variation EMEA/H/C/594/IB/7
13/10/2005 Centralised - Variation EMEA/H/C/594/IB/9
27/10/2005 Centralised - Variation EMEA/H/C/594/II/5 (2005)4261 of 25/10/2005
18/11/2005 Centralised - Variation EMEA/H/C/594/II/3 (2005)4518 of 16/11/2005
21/12/2005 Centralised - Variation EMEA/H/C/594/IB/12
21/12/2005 Centralised - Variation EMEA/H/C/594/IA/14
03/01/2006 Centralised - Variation EMEA/H/C/594/II/10 (2005)6021 of 23/12/2005
16/01/2006 Centralised - Variation EMEA/H/C/594/IB/15
02/03/2006 Centralised - Variation EMEA/H/C/594/II/11 (2006)687 of 28/02/2006
31/03/2006 Centralised - Variation EMEA/H/C/594/II/13 (2006)1355 of 29/03/2006
26/04/2006 Corrigendum EMEA/H/C/594/II/11 (2006)687 corr of 24/04/2006
26/04/2006 Corrigendum EMEA/H/C/594/II/13 (2006)1355 corr of 24/04/2006
01/06/2006 Centralised - Variation EMEA/H/C/594/IA/16
01/06/2006 Centralised - Variation EMEA/H/C/594/IA/17
04/07/2006 Centralised - Variation EMEA/H/C/594/IA/20
11/08/2006 Centralised - Variation EMEA/H/C/594/IB/22
11/08/2006 Centralised - Variation EMEA/H/C/594/IB/21
31/08/2006 Centralised - Variation EMEA/H/C/594/II/18 (2006)3926 of 28/08/2006
11/01/2007 Centralised - Variation EMEA/H/C/594/IB/26
11/01/2007 Centralised - Variation EMEA/H/C/594/IB/27
16/01/2007 Centralised - Variation EMEA/H/C/594/II/24 (2007)156 of 12/01/2007
26/02/2007 Centralised - Variation EMEA/H/C/594/II/28
26/02/2007 Centralised - Variation EMEA/H/C/594/II/23
05/03/2007 Centralised - Variation EMEA/H/C/594/II/25 (2007)761 of 01/03/2007
14/03/2007 Centralised - Variation EMEA/H/C/594/IA/31
Updated with Decision(2007)1898 of 24/04/2007
17/04/2007 Centralised - Variation EMEA/H/C/594/IB/32
Updated with Decision(2007)6090 of 30/11/2007
26/04/2007 Centralised - Variation EMEA/H/C/594/II/29, 30 (2007)1898 of 24/04/2007
07/06/2007 Centralised - Variation EMEA/H/C/594/IA/33
Updated with Decision(2007)6090 of 30/11/2007
26/09/2007 Centralised - Variation EMEA/H/C/594/II/34
19/10/2007 Centralised - Variation EMEA/H/C/594/IA/38
19/10/2007 Centralised - Variation EMEA/H/C/594/IA/37
19/10/2007 Centralised - Variation EMEA/H/C/594/IA/39
14/11/2007 Centralised - Variation EMEA/H/C/594/IA/40
04/12/2007 Centralised - Variation (2007)6090 of 30/11/2007
20/12/2007 Centralised - Variation EMEA/H/C/594/II/35 (2007)6763 of 18/12/2007
28/02/2008 Centralised - Variation EMEA/H/C/594/IA/41
03/03/2008 Centralised - Variation EMEA/H/C/594/II/36 (2008)839 of 28/02/2008
14/05/2008 Centralised - Variation EMEA/H/C/594/IA/43
Updated with Decision(2008)4771 of 29/08/2008
05/06/2008 Centralised - Variation EMEA/H/C/594/IB/46
Updated with Decision(2008)4771 of 29/08/2008
08/08/2008 Centralised - Variation EMEA/H/C/594/IA/48
08/08/2008 Centralised - Variation EMEA/H/C/594/IA/49
08/08/2008 Centralised - Variation EMEA/H/C/594/IA/47
02/09/2008 Centralised - Variation EMEA/H/C/594/II/45 (2008)4771 of 29/08/2008
22/09/2008 Centralised - Variation EMEA/H/C/594/IA/50
21/10/2008 Centralised - Variation EMEA/H/C/594/IA/51
24/12/2008 Centralised - Variation EMEA/H/C/594/II/44 (2008)8981 of 22/12/2008
07/01/2009 Centralised - Variation EMEA/H/C/594/IB/53
07/01/2009 Centralised - Variation EMEA/H/C/594/IB/52
07/04/2009 Centralised - Variation EMEA/H/C/594/IA/56
07/04/2009 Centralised - Variation EMEA/H/C/594/IA/55
28/04/2009 Centralised - Variation EMEA/H/C/594/IB/57
15/05/2009 Centralised - Variation EMEA/H/C/594/IB/58
Updated with Decision(2009)10236 of 10/12/2009
29/05/2009 Centralised - Variation EMEA/H/C/594/IA/61
01/06/2009 Centralised - Variation EMEA/H/C/594/IA/60
17/06/2009 Centralised - Variation EMEA/H/C/594/IB/59
14/12/2009 Centralised - Variation (2009)10236 of 10/12/2009
22/01/2010 Centralised - Renewal EMEA/H/C/594/R/62 (2010)374 of 20/01/2010
13/08/2010 Centralised - Variation EMEA/H/C/594/IA/65
Updated with Decision(2010)8534 of 26/11/2010
02/09/2010 Centralised - Variation EMEA/H/C/594/II/54 (2010)6096 of 31/08/2010
23/09/2010 Centralised - Variation EMEA/H/C/594/IA/66
28/10/2010 Centralised - Variation EMEA/H/C/594/WS/48
28/10/2010 Centralised - Variation EMEA/H/C/594/WS/47
01/12/2010 Centralised - Variation EMEA/H/C/594/II/63 (2010)8534 of 26/11/2010
22/03/2011 Centralised - Variation EMEA/H/C/594/IA/67
30/03/2011 Centralised - Variation EMEA/H/C/594/IG/47/G
Updated with Decision(2011)3879 of 27/05/2011
04/05/2011 Centralised - Variation EMEA/H/C/594/IA/68
Updated with Decision(2011)5604 of 27/07/2011
31/05/2011 Centralised - Variation (2011)3879 of 27/05/2011
03/08/2011 Centralised - Variation EMEA/H/C/594/WS/115 (2011)5604 of 27/07/2011
27/02/2013 Centralised - Variation EMEA/H/C/594/N/85
Updated with Decision(2013)4236 of 01/07/2013
03/07/2013 Centralised - Variation EMEA/H/C/594/WS/391 (2013)4236 of 01/07/2013
26/02/2014 Centralised - Variation EMEA/H/C/594/N/95
20/03/2014 Centralised - Variation EMEA/H/C/594/WS/530
24/07/2014 Centralised - Variation EMEA/H/C/594/WS/575
24/07/2014 Centralised - Variation EMEA/H/C/594/WS/586