Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Emtriva   
Auth. number : EU/1/03/261
INN : Emtricitabine
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: J05AF - Nucleoside and nucleotide reverse transcriptase inhibitors
Chemical substance: J05AF09 - Emtricitabine
(See WHO ATC Index)
Indication: Emtriva is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infected adults and children aged four months and over.

This indication is based on studies in treatment naïve patients and treatment experienced patients with stable virological control. There is no experience of the use of Emtriva in patients who are failing their current regimen or who have failed multiple regimens.

When deciding on a new regimen for patients who have failed an antiretroviral regimen, careful consideration should be given to the patterns of mutations associated with different medicinal products and the treatment history of the individual patient. Where available, resistance testing may be appropriate.
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
27/10/2003 Centralised - Authorisation EMEA/H/C/533 (2003)4025 of 24/10/2003
26/01/2004 Centralised - Variation EMEA/H/C/533/II/1
09/06/2004 Centralised - Variation EMEA/H/C/533/IB/8
25/06/2004 Centralised - Variation EMEA/H/C/533/II/5 (2004)2396 of 23/06/2004
21/07/2004 Centralised - Variation EMEA/H/C/533/IB/10
Updated with Decision(2004)5378 of 17/12/2004
21/07/2004 Centralised - Variation EMEA/H/C/533/IB/9
Updated with Decision(2004)5378 of 17/12/2004
04/08/2004 Centralised - Variation EMEA/H/C/533/II/6 (2004)3044 of 02/08/2004
16/08/2004 Centralised - Variation EMEA/H/C/533/N/11
Updated with Decision(2004)5378 of 17/12/2004
27/10/2004 Centralised - Variation EMEA/H/C/533/II/12
22/12/2004 Centralised - Variation EMEA/H/C/533/II/13 (2004)5378 of 17/12/2004
07/03/2005 Centralised - Variation EMEA/H/C/533/II/14 (2005)569 of 03/03/2005
08/04/2005 Centralised - Variation EMEA/H/C/533/N/15
Updated with Decision(2005)3475 of 07/09/2005
28/04/2005 Centralised - Variation EMEA/H/C/533/IA/17
11/05/2005 Centralised - Variation EMEA/H/C/533/IA/18
11/05/2005 Centralised - Variation EMEA/H/C/533/IA/21
11/05/2005 Centralised - Variation EMEA/H/C/533/IA/19
11/05/2005 Centralised - Variation EMEA/H/C/533/IA/20
11/05/2005 Centralised - Variation EMEA/H/C/533/IA/22
09/09/2005 Centralised - Variation EMEA/H/C/533/II/16 (2005)3475 of 07/09/2005
18/11/2005 Centralised - Variation EMEA/H/C/533/II/23 (2005)4492 of 15/11/2005
07/12/2005 Centralised - Variation EMEA/H/C/533/IB/24
23/01/2006 Centralised - Variation EMEA/H/C/533/N/25
Updated with Decision(2006)1797 of 27/04/2006
27/03/2006 Centralised - Variation EMEA/H/C/533/IA/28
27/03/2006 Centralised - Variation EMEA/H/C/533/IA/27
02/05/2006 Centralised - Variation EMEA/H/C/533/II/26 (2006)1797 of 27/04/2006
18/05/2006 Centralised - Variation EMEA/H/C/533/IA/29
04/08/2006 Centralised - Variation EMEA/H/C/533/IA/37
07/08/2006 Centralised - Variation EMEA/H/C/533/N/30
Updated with Decision(2007)157 of 12/01/2007
09/08/2006 Centralised - Variation EMEA/H/C/533/IA/33
11/08/2006 Centralised - Variation EMEA/H/C/533/IA/35
11/08/2006 Centralised - Variation EMEA/H/C/533/IA/36
23/08/2006 Centralised - Variation EMEA/H/C/533/IB/32
23/08/2006 Centralised - Variation EMEA/H/C/533/IB/31
27/09/2006 Centralised - Variation EMEA/H/C/533/IB/34
16/01/2007 Centralised - Variation EMEA/H/C/533/II/38 (2007)157 of 12/01/2007
14/03/2007 Centralised - Variation EMEA/H/C/533/IA/41
Updated with Decision(2007)1915 of 25/04/2007
29/03/2007 Centralised - Variation EMEA/H/C/533/II/39 (2007)1489 of 27/03/2007
27/04/2007 Centralised - Variation EMEA/H/C/533/II/40 (2007)1915 of 25/04/2007
27/06/2007 Centralised - Variation EMEA/H/C/533/II/43
04/07/2007 Centralised - Variation EMEA/H/C/533/IA/46
20/07/2007 Centralised - Variation EMEA/H/C/533/IB/45
20/07/2007 Centralised - Variation EMEA/H/C/533/IB/49
20/07/2007 Centralised - Variation EMEA/H/C/533/IB/47
24/08/2007 Centralised - Variation EMEA/H/C/533/II/44 (2007)4030 of 22/08/2007
14/09/2007 Centralised - Variation EMEA/H/C/533/IB/48
19/10/2007 Centralised - Variation EMEA/H/C/533/IA/52
19/10/2007 Centralised - Variation EMEA/H/C/533/IA/50
19/10/2007 Centralised - Variation EMEA/H/C/533/IA/51
20/02/2008 Centralised - Variation EMEA/H/C/533/IA/53
01/04/2008 Centralised - Variation EMEA/H/C/533/IA/54
08/07/2008 Centralised - Variation EMEA/H/C/533/IA/58
29/07/2008 Centralised - Variation EMEA/H/C/533/IB/56
29/07/2008 Centralised - Variation EMEA/H/C/533/IB/57
24/09/2008 Centralised - Renewal EMEA/H/C/533/R/55 (2008)5448 of 22/09/2008
05/11/2008 Centralised - Variation EMEA/H/C/533/IA/64
05/11/2008 Centralised - Variation EMEA/H/C/533/IA/59
05/11/2008 Centralised - Variation EMEA/H/C/533/IA/68
05/11/2008 Centralised - Variation EMEA/H/C/533/IA/60
05/11/2008 Centralised - Variation EMEA/H/C/533/IA/67
05/11/2008 Centralised - Variation EMEA/H/C/533/IA/61
05/11/2008 Centralised - Variation EMEA/H/C/533/IA/63
05/11/2008 Centralised - Variation EMEA/H/C/533/IA/66
10/11/2008 Centralised - Variation EMEA/H/C/533/IA/65
Updated with Decision(2009)5047 of 18/06/2009
26/01/2009 Centralised - Variation EMEA/H/C/533/II/62
20/04/2009 Centralised - Variation EMEA/H/C/533/IB/69
12/05/2009 Centralised - Variation EMEA/H/C/533/IA/70
01/06/2009 Centralised - Variation EMEA/H/C/533/IA/72
01/06/2009 Centralised - Variation EMEA/H/C/533/IA/73
Updated with Decision(2009)10593 of 18/12/2009
22/06/2009 Centralised - Variation (2009)5047 of 18/06/2009
20/11/2009 Centralised - Variation EMEA/H/C/533/IA/75
22/12/2009 Centralised - Variation (2009)10593 of 18/12/2009
13/08/2010 Centralised - Variation EMEA/H/C/533/IA/76
Updated with Decision(2011)2700 of 12/04/2011
31/08/2010 Centralised - Variation EMEA/H/C/533/II/74 (2010)6003 of 26/08/2010
28/10/2010 Centralised - Variation EMEA/H/C/533/WS/48
30/03/2011 Centralised - Variation EMEA/H/C/533/IG/47/G
Updated with Decision(2011)3728 of 23/05/2011
14/04/2011 Centralised - Variation (2011)2700 of 12/04/2011
20/04/2011 Centralised - Variation EMEA/H/C/533/IA/77
Updated with Decision(2011)3728 of 23/05/2011
26/05/2011 Centralised - Variation (2011)3728 of 23/05/2011
03/08/2011 Centralised - Variation EMEA/H/C/533/WS/115 (2011)5603 of 27/07/2011
03/07/2013 Centralised - Variation EMEA/H/C/533/WS/391 (2013)4235 of 01/07/2013
20/03/2014 Centralised - Variation EMEA/H/C/533/WS/530