Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Atripla   
Auth. number : EU/1/07/430
INN : efavirenz / 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: J05AR06 - Emtricitabine, tenofovir disoproxil and efavirenz
(See WHO ATC Index)
Indication: Atripla is a fixed-dose combination of efavirenz, emtricitabine and tenofovir disoproxil fumarate. It is indicated for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years and over with virologic suppression to HIV-1 RNA levels of < 50 copies/ml on their current combination antiretroviral therapy for more than three months. Patients must not have experienced virological failure on any prior antiretroviral therapy and must be known not to have harboured virus strains with mutations conferring significant resistance to any of the three components contained in Atripla prior to initiation of their first antiretroviral treatment regimen.
The demonstration of the benefit of Atripla is primarily based on 48-week data from a clinical study in which patients with stable virologic suppression on a combination antiretroviral therapy changed to Atripla . No data are currently available from clinical studies with Atripla in treatment-naïve or in heavily pretreated patients.
Marketing Authorisation Holder: Bristol-Myers Squibb and Gilead Sciences Limited
IDA Business & Technology Park, Carrigtohill, Co. Cork, Ireland

  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
18/12/2007 Centralised - Authorisation EMEA/H/C/797 (2007)6572 of 13/12/2007
08/02/2008 Centralised - Variation EMEA/H/C/797/IA/5
08/02/2008 Centralised - Variation EMEA/H/C/797/IA/7
08/02/2008 Centralised - Variation EMEA/H/C/797/IA/6
14/02/2008 Centralised - Variation EMEA/H/C/797/N/2
Updated with Decision(2008)3071 of 18/06/2008
15/02/2008 Centralised - Variation EMEA/H/C/797/IA/1
Updated with Decision(2008)3071 of 18/06/2008
15/02/2008 Centralised - Variation EMEA/H/C/797/IA/4
Updated with Decision(2008)3071 of 18/06/2008
10/04/2008 Centralised - Variation EMEA/H/C/797/IA/12
10/04/2008 Centralised - Variation EMEA/H/C/797/IA/10
10/04/2008 Centralised - Variation EMEA/H/C/797/IA/9
10/04/2008 Centralised - Variation EMEA/H/C/797/IA/17
10/04/2008 Centralised - Variation EMEA/H/C/797/IA/15
10/04/2008 Centralised - Variation EMEA/H/C/797/IA/13
10/04/2008 Centralised - Variation EMEA/H/C/797/IA/16
10/04/2008 Centralised - Variation EMEA/H/C/797/IA/11
10/04/2008 Centralised - Variation EMEA/H/C/797/IA/14
23/05/2008 Centralised - Variation EMEA/H/C/797/IB/20
Updated with Decision(2008)7696 of 26/11/2008
23/06/2008 Centralised - Variation EMEA/H/C/797/II/3, 8 (2008)3071 of 18/06/2008
09/07/2008 Centralised - Variation EMEA/H/C/797/IA/22
16/07/2008 Centralised - Variation EMEA/H/C/797/II/18
11/09/2008 Centralised - Variation EMEA/H/C/797/IB/21
11/09/2008 Centralised - Variation EMEA/H/C/797/IB/23
28/11/2008 Centralised - Variation EMEA/H/C/797/II/24 (2008)7696 of 26/11/2008
17/12/2008 Centralised - Variation EMEA/H/C/797/IA/25
Updated with Decision(2009)6744 of 31/08/2009
05/01/2009 Centralised - Variation EMEA/H/C/797/II/19 (2008)8978 of 22/12/2008
15/04/2009 Centralised - Variation EMEA/H/C/797/IA/30
15/04/2009 Centralised - Variation EMEA/H/C/797/IA/28
15/04/2009 Centralised - Variation EMEA/H/C/797/IB/27
15/04/2009 Centralised - Variation EMEA/H/C/797/IB/26
Updated with Decision(2009)6744 of 31/08/2009
23/04/2009 Centralised - Variation EMEA/H/C/797/IB/31
27/05/2009 Centralised - Variation EMEA/H/C/797/IA/33
28/05/2009 Centralised - Variation EMEA/H/C/797/IA/32
10/06/2009 Centralised - Variation EMEA/H/C/797/IA/35
17/08/2009 Centralised - Variation EMEA/H/C/797/IA/37
17/08/2009 Centralised - Variation EMEA/H/C/797/IA/36
02/09/2009 Centralised - Variation EMEA/H/C/797/IA/38
Updated with Decision(2010)1775 of 15/03/2010
02/09/2009 Centralised - Variation (2009)6744 of 31/08/2009
09/09/2009 Centralised - Variation EMEA/H/C/797/IB/34
27/01/2010 Centralised - Variation EMEA/H/C/797/IB/39
10/03/2010 Centralised - Variation EMEA/H/C/797/IA/40
19/03/2010 Centralised - Variation (2010)1775 of 15/03/2010
26/04/2010 Centralised - Variation EMEA/H/C/797/IB/42
26/04/2010 Centralised - Variation EMEA/H/C/797/IB/41
Updated with Decision(2010)9604 of 20/12/2010
12/05/2010 Centralised - Variation EMEA/H/C/797/II/29 (2010)3166 of 10/05/2010
19/08/2010 Centralised - Variation EMEA/H/C/797/IA/43
24/09/2010 Centralised - Variation EMEA/H/C/797/IA/45
11/11/2010 Centralised - Variation EMEA/H/C/797/WS/48
11/11/2010 Centralised - Variation EMEA/H/C/797/WS/47
23/12/2010 Centralised - Variation EMEA/H/C/797/II/44 (2010)9604 of 20/12/2010
25/07/2011 Centralised - Variation EMEA/H/C/797/IB/46/G
Updated with Decision(2011)6084 of 19/08/2011
23/08/2011 Centralised - Variation EMEA/H/C/797/WS/115 (2011)6084 of 19/08/2011
28/10/2011 Centralised - Variation EMEA/H/C/797/IA/52/G
Updated with Decision(2011)8679 of 22/11/2011
24/11/2011 Centralised - Variation EMEA/H/C/797/II/50 (2011)8679 of 22/11/2011
13/04/2012 Corrigendum
19/09/2012 Centralised - Renewal EMEA/H/C/797/R/62 (2012)6528 of 17/09/2012
06/11/2012 Centralised - Variation EMEA/H/C/797/IB/65
Updated with Decision(2013)3820 of 13/06/2013
13/12/2012 Centralised - Variation EMEA/H/C/797/II/66
Updated with Decision(2013)3820 of 13/06/2013
13/12/2012 Centralised - Variation EMEA/H/C/797/II/67
Updated with Decision(2013)3820 of 13/06/2013
17/06/2013 Centralised - Variation EMEA/H/C/797/WS/391 (2013)3820 of 13/06/2013
21/01/2014 Centralised - Variation EMEA/H/C/797/IB/79
23/01/2014 Centralised - Variation EMEA/H/C/797/II/75
20/02/2014 Centralised - Variation EMEA/H/C/797/II/80, 81
20/03/2014 Centralised - Variation EMEA/H/C/797/WS/530
22/05/2014 Centralised - Variation EMEA/H/C/797/II/84
16/07/2014 Centralised - Variation EMEA/H/C/797/IAIN/92
24/07/2014 Centralised - Variation EMEA/H/C/797/WS/586/89
24/07/2014 Centralised - Variation EMEA/H/C/797/WS/575