Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Sustiva   
Auth. number : EU/1/99/110
INN : efavirenz
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: J05AG03 - Efavirenz
(See WHO ATC Index)
Indication: SUSTIVA is indicated in antiviral combination treatment of human immunodeficiency virus-1 (HIV-1) infected adults, adolescents and children 3 years of age and older.SUSTIVA has not been adequately studied in patients with advanced HIV disease, namely in patients with CD4 counts < 50 cells/mm3, or after failure of protease inhibitor (PI) containing regimens.Although cross-resistance of efavirenz with PIs has not been documented, there are at present insufficient data on the efficacy of subsequent use of PI based combination therapy after failure of regimens containing SUSTIVA.
Marketing Authorisation Holder: Bristol-Myers Squibb Pharma EEIG
Uxbridge Business Park, Sanderson Road, Uxbridge UB8 1DH, 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 continues to be 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
07/06/1999 Centralised - Authorisation EMEA/H/C/249 (1999)1428 of 28/05/1999
02/09/1999 Centralised - Variation EMEA/H/C/249/I/1 (1999)2817 of 23/08/1999
02/02/2000 Centralised - Variation EMEA/H/C/249/II/2 (2000)123 of 31/01/2000
31/05/2000 Centralised - Variation EMEA/H/C/249/II/4 (2000)1284 of 24/05/2000
12/10/2000 Centralised - Variation EMEA/H/C/249/II/9
25/10/2000 Centralised - Variation EMEA/H/C/249/II/6, 8 (2000)2829 of 13/10/2000
14/05/2001 Centralised - Variation EMEA/H/C/249/II/11
14/05/2001 Centralised - Variation EMEA/H/C/249/I/16
19/06/2001 Centralised - Variation EMEA/H/C/249/II/12 (2001)1324 of 14/06/2001
24/09/2001 Centralised - Variation EMEA/H/C/249/II/14 (2001)2733 of 20/09/2001
19/10/2001 Centralised - Variation EMEA/H/C/249/X/7 (2001)2854 of 18/10/2001
07/11/2001 Centralised - Variation EMEA/H/C/249/I/20
07/01/2002 Centralised - Variation EMEA/H/C/249/I/21
08/03/2002 Centralised - Variation EMEA/H/C/249/I/25
08/03/2002 Centralised - Variation EMEA/H/C/249/I/22
25/03/2002 Centralised - Variation EMEA/H/C/249/I/23, 24 (2002)1275 of 21/03/2002
04/04/2002 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/249/T/28 (2002)1390 of 02/04/2002
24/04/2002 Centralised - Variation EMEA/H/C/249/II/19 (2002)1470 of 12/04/2002
09/05/2002 Centralised - Variation EMEA/H/C/249/I/30 (2002)1877 of 07/05/2002
24/06/2002 Centralised - Variation EMEA/H/C/249/N/31 (2002)2420 of 20/06/2002
15/07/2002 Centralised - Variation EMEA/H/C/249/N/32 (2002)2704 of 10/07/2002
27/08/2002 Centralised - Variation EMEA/H/C/249/X/17, 18 (2002)3180 of 22/08/2002
05/09/2002 Centralised - Variation EMEA/H/C/249/II/29 (2002)3325 of 30/08/2002
02/10/2002 Centralised - Variation EMEA/H/C/249/II/27 (2002)3656 of 30/09/2002
09/12/2002 Centralised - Variation EMEA/H/C/249/N/33 (2002)4961 of 04/12/2002
22/05/2003 Centralised - Variation EMEA/H/C/249/II/34 (2003)1727 of 19/05/2003
27/06/2003 Centralised - Variation EMEA/H/C/249/I/36 (2003)2088 of 25/06/2003
15/07/2003 Centralised - Variation EMEA/H/C/249/II/35 (2003)2555 of 09/07/2003
22/07/2003 Centralised - Variation EMEA/H/C/249/I/37
23/10/2003 Centralised - Variation EMEA/H/C/249/I/39
04/02/2004 Centralised - Variation EMEA/H/C/249/IA/45
04/02/2004 Centralised - Variation EMEA/H/C/249/IA/44
09/02/2004 Centralised - Variation EMEA/H/C/249/II/38 (2004)409 of 05/02/2004
03/03/2004 Centralised - Variation EMEA/H/C/249/IA/42
04/05/2004 Centralised - Renewal EMEA/H/C/249/R/42 (2004)1777 of 29/04/2004
15/07/2004 Centralised - Variation EMEA/H/C/249/II/40 (2004)2805 of 13/07/2004
30/09/2004 Centralised - Variation EMEA/H/C/249/II/46
19/11/2004 Centralised - Variation EMEA/H/C/249/IA/51
08/12/2004 Centralised - Variation EMEA/H/C/249/II/48 (2004)4846 of 06/12/2004
07/01/2005 Centralised - Variation EMEA/H/C/249/II/49 (2005)17 of 05/01/2005
09/03/2005 Centralised - Variation EMEA/H/C/249/II/50 (2005)666 of 07/03/2005
18/03/2005 Centralised - Variation EMEA/H/C/249/IA/52
02/08/2005 Centralised - Variation EMEA/H/C/249/IA/60
02/08/2005 Centralised - Variation EMEA/H/C/249/IA/59
11/08/2005 Centralised - Variation EMEA/H/C/249/II/53, 54 (2005)3159 of 09/08/2005
08/09/2005 Centralised - Variation EMEA/H/C/249/IA/61
Updated with Decision(2005)4270 of 25/10/2005
27/10/2005 Centralised - Variation EMEA/H/C/249/II/56, 57, 58 (2005)4270 of 25/10/2005
03/01/2006 Centralised - Variation EMEA/H/C/249/II/55 (2005)6012 of 23/12/2005
06/09/2006 Centralised - Variation EMEA/H/C/249/II/62 (2006)4059 of 01/09/2006
30/10/2006 Centralised - Variation EMEA/H/C/249/II/63 (2006)5208 of 26/10/2006
20/11/2006 Centralised - Variation EMEA/H/C/249/IA/64
13/12/2006 Centralised - Variation EMEA/H/C/249/IA/66
18/01/2007 Centralised - Variation EMEA/H/C/249/II/65 (2007)163 of 15/01/2007
04/05/2007 Centralised - Variation EMEA/H/C/249/II/67 (2007)2026 of 02/05/2007
05/07/2007 Centralised - Variation EMEA/H/C/249/II/8 (2007)3308 of 02/07/2007
27/07/2007 Centralised - Variation EMEA/H/C/249/IA/70
28/08/2007 Centralised - Variation EMEA/H/C/249/II/69 (2007)4050 of 23/08/2007
05/10/2007 Centralised - Variation EMEA/H/C/249/IA/71
07/02/2008 Centralised - Variation EMEA/H/C/249/IA/73
19/02/2008 Centralised - Variation EMEA/H/C/249/IB/72
21/02/2008 Centralised - Variation EMEA/H/C/249/IA/75
13/05/2008 Centralised - Variation EMEA/H/C/249/IA/77
11/06/2008 Centralised - Variation EMEA/H/C/249/IB/78
01/07/2008 Centralised - Variation EMEA/H/C/249/IB/80
15/07/2008 Centralised - Variation EMEA/H/C/249/II/74 (2008)3712 of 11/07/2008
09/09/2008 Centralised - Variation EMEA/H/C/249/IA/81
17/09/2008 Centralised - Variation EMEA/H/C/249/II/79 (2008)5217 of 15/09/2008
25/11/2008 Centralised - Variation EMEA/H/C/249/IA/88
25/11/2008 Centralised - Variation EMEA/H/C/249/IA/87
25/11/2008 Centralised - Variation EMEA/H/C/249/IA/86
27/11/2008 Centralised - Variation EMEA/H/C/249/II/82
03/12/2008 Centralised - Variation EMEA/H/C/249/II/76 (2008)7920 of 01/12/2008
03/02/2009 Centralised - Variation EMEA/H/C/249/IA/91
04/02/2009 Centralised - Variation EMEA/H/C/249/IB/90
Updated with Decision(2009)3184 of 22/04/2009
10/03/2009 Centralised - Variation EMEA/H/C/249/IA/92
10/03/2009 Centralised - Variation EMEA/H/C/249/IA/92
Updated with Decision(2009)4418 of 02/06/2009
10/03/2009 Centralised - Variation EMEA/H/C/249/IA/93
11/03/2009 Centralised - Variation EMEA/H/C/249/II/85 (2009)1834 of 09/03/2009
24/04/2009 Centralised - Renewal EMEA/H/C/249/R/89 (2009)3184 of 22/04/2009
05/06/2009 Centralised - Variation EMEA/H/C/249/II/83 (2009)4418 of 02/06/2009
11/06/2009 Centralised - Variation EMEA/H/C/249/IA/95
03/07/2009 Centralised - Variation EMEA/H/C/249/IA/96
24/08/2009 Centralised - Variation EMEA/H/C/249/IA/99
26/08/2009 Centralised - Variation EMEA/H/C/249/IA/100
28/08/2009 Centralised - Variation EMEA/H/C/249/IA/101
16/09/2009 Centralised - Variation EMEA/H/C/249/IB/98
04/11/2009 Centralised - Variation EMEA/H/C/249/IA/103
Updated with Decision(2010)2163 of 26/03/2010
12/11/2009 Centralised - Variation EMEA/H/C/249/IB/102
11/12/2009 Centralised - Variation EMEA/H/C/249/II/97 (2009)10144 of 09/12/2009
23/03/2010 Centralised - Variation EMEA/H/C/249/IA/105/G
Updated with Decision(2010)5607 of 06/08/2010
30/03/2010 Centralised - Variation (2010)2163 of 26/03/2010
10/08/2010 Centralised - Variation (2010)5607 of 06/08/2010
10/09/2010 Centralised - Variation EMEA/H/C/249/IA/106
Updated with Decision(2010)7732 of 03/11/2010
09/11/2010 Centralised - Variation EMEA/H/C/249/II/104 (2010)7732 of 03/11/2010
16/03/2011 Centralised - Variation EMEA/H/C/249/IA/107
Updated with Decision(2011)5204 of 13/07/2011
08/07/2011 Centralised - Variation EMEA/H/C/249/IA/109
Updated with Decision(2011)7251 of 06/10/2011
18/07/2011 Centralised - Variation EMEA/H/C/249/WS/116 (2011)5204 of 13/07/2011
10/10/2011 Centralised - Variation (2011)7251 of 06/10/2011
02/07/2012 Centralised - Variation EMEA/H/C/249/WS/210 (2012)4507 of 27/06/2012
01/05/2013 Centralised - Variation EMEA/H/C/249/WS/357 (2013)2644 of 29/04/2013
03/07/2013 Centralised - Variation EMEA/H/C/249/WS/388 (2013)4241 of 01/07/2013
24/10/2013 Centralised - Variation EMEA/H/C/249/WS/433
24/10/2013 Centralised - Variation EMEA/H/C/249/WS/435
18/11/2013 Centralised - Variation EMEA/H/C/249/IA/121/G
23/01/2014 Centralised - Variation EMEA/H/C/249/WS/486
23/01/2014 Centralised - Variation EMEA/H/C/249/WS/434