Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Truvada   
Auth. number : EU/1/04/305
Active substance : 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: Treatment of HIV-1 infection:
Truvada is indicated in antiretroviral combination therapy for the treatment of HIV-1 infected adults.

Pre-exposure prophylaxis (PrEP):
Truvada is indicated in combination with safer sex practices for pre-exposure prophylaxis to reduce the risk of sexually acquired HIV-1 infection in adults at high risk.
Marketing Authorisation Holder: Gilead Sciences International Ltd.
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 (no change in Commission Decision) EMEA/H/C/594/IA/1
28/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/II/2
03/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IB/4
30/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IA/8
19/09/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IB/7
13/10/2005 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/594/IA/14
21/12/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IB/12
03/01/2006 Centralised - Variation EMEA/H/C/594/II/10 (2005)6021 of 23/12/2005
16/01/2006 Centralised - Variation (no change in Commission Decision) 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/13 (2006)1355 cor of 24/04/2006
26/04/2006 Corrigendum EMEA/H/C/594/II/11 (2006)687 cor of 24/04/2006
01/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IA/16
01/06/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IA/17
04/07/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IA/20
11/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IB/22
11/08/2006 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/594/IB/27
11/01/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IB/26
16/01/2007 Centralised - Variation EMEA/H/C/594/II/24 (2007)156 of 12/01/2007
26/02/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/II/28
26/02/2007 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/594/II/34
19/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IA/37
19/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IA/39
19/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IA/38
14/11/2007 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/594/IA/47
08/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IA/49
08/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IA/48
02/09/2008 Centralised - Variation EMEA/H/C/594/II/45 (2008)4771 of 29/08/2008
22/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IA/50
21/10/2008 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/594/IB/52
07/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IB/53
07/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IA/55
07/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IA/56
28/04/2009 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/594/IA/61
01/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/IA/60
17/06/2009 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) EMEA/H/C/594/IA/66
28/10/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/594/WS/48
28/10/2010 Centralised - Variation (no change in Commission Decision) 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 (no change in Commission Decision) 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 - Notification EMEA/H/C/594/N/85
Updated with Decision(2013)4236 of 01/07/2013
03/07/2013 Centralised - 2-Monthly update EMEA/H/C/594/WS/391 (2013)4236 of 01/07/2013
26/02/2014 Centralised - Notification EMEA/H/C/594/N/95
Updated with Decision(2015)1682 of 10/03/2015
20/03/2014 Centralised - Variation EMEA/H/C/594/WS/530
Updated with Decision(2015)1682 of 10/03/2015
24/07/2014 Centralised - Variation EMEA/H/C/594/WS/575
Updated with Decision(2015)1682 of 10/03/2015
24/07/2014 Centralised - Variation EMEA/H/C/594/WS/586
Updated with Decision(2015)1682 of 10/03/2015
18/12/2014 Centralised - Variation EMEA/H/C/594/WS/650
Updated with Decision(2015)1682 of 10/03/2015
26/02/2015 Centralised - Variation EMEA/H/C/594/IG/521
Updated with Decision(2016)942 of 11/02/2016
12/03/2015 Centralised - Yearly update (2015)1682 of 10/03/2015
09/06/2015 Centralised - Variation EMEA/H/C/594/IG/572
Updated with Decision(2016)942 of 11/02/2016
17/12/2015 Centralised - Variation EMEA/H/C/594/WS/731
Updated with Decision(2016)942 of 11/02/2016
28/01/2016 Centralised - Variation EMEA/H/C/594/WS/884
Updated with Decision(2016)5439 of 18/08/2016
15/02/2016 Centralised - Yearly update (2016)942 of 11/02/2016
01/04/2016 Centralised - Variation EMEA/H/C/594/WS/792
Updated with Decision(2016)5439 of 18/08/2016
01/04/2016 Centralised - Variation EMEA/H/C/594/WS/829
Updated with Decision(2016)5439 of 18/08/2016
22/08/2016 Centralised - 2-Monthly update EMEA/H/C/594/II/126 (2016)5439 of 18/08/2016