Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


NOT RENEWED  

Product information

Invented name: Viracept
Auth. number : EU/1/97/054
INN : Nelfinavir
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: J05AE - Protease inhibitors
Chemical substance: J05AE04 - Nelfinavir
(See WHO ATC Index)
Indication: Antiretroviral combination treatment of human immunodeficiency virus (HIV-1) infected adults, adolescents and children of 3 years of age and older. In protease inhibitor (PI) experienced patients the choice of nelfinavir should be based on individual viral resistance testing and treatment history.
Marketing Authorisation Holder: Roche Registration Limited
6 Falcon Way, Shire Park, Welwyn Garden City, AL7 1TW, 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
23/01/1998 Centralised - Authorisation EMEA/H/C/164 (1998)175 of 22/01/1998
18/03/1999 Centralised - Variation EMEA/H/C/164/II/29 (1999)690 of 12/03/1999
20/04/1999 Centralised - Variation EMEA/H/C/164/I/31, 32, 34
17/05/1999 Centralised - Variation EMEA/H/C/164/I/33, 35, 37
17/06/1999 Centralised - Variation EMEA/H/C/164/I/38 (1999)1495 of 03/06/1999
16/07/1999 Centralised - Variation EMEA/H/C/164/I/39
05/08/1999 Centralised - Variation EMEA/H/C/164/II/30 (1999)2568 of 30/07/1999
05/08/1999 Centralised - Annual reassessment EMEA/H/C/164/S/40 (1999)2549 of 29/07/1999
23/11/1999 Centralised - Variation EMEA/H/C/164/II/41 (1999)3791 of 16/11/1999
28/02/2000 Centralised - Variation EMEA/H/C/164/I/48
28/02/2000 Centralised - Variation EMEA/H/C/164/I/47
28/02/2000 Centralised - Variation EMEA/H/C/164/I/50
14/03/2000 Centralised - Variation EMEA/H/C/164/I/43 (2000)601 of 09/03/2000
14/03/2000 Centralised - Variation EMEA/H/C/164/I/42 (2000)601 of 09/03/2000
14/03/2000 Centralised - Variation EMEA/H/C/164/I/45 (2000)601 of 09/03/2000
14/03/2000 Centralised - Variation EMEA/H/C/164/I/44 (2000)601 of 09/03/2000
05/04/2000 Centralised - Variation EMEA/H/C/164/I/49
08/05/2000 Centralised - Variation EMEA/H/C/164/I/54
10/05/2000 Centralised - Variation EMEA/H/C/164/I/53
10/05/2000 Centralised - Variation EMEA/H/C/164/I/52
10/07/2000 Centralised - Variation EMEA/H/C/164/II/46 (2000)1744 of 04/07/2000
20/07/2000 Centralised - Annual reassessment EMEA/H/C/164/S/51 (2000)2032 of 13/07/2000
25/10/2000 Centralised - Variation EMEA/H/C/164/II/55 (2000)2858 of 24/10/2000
16/11/2000 Centralised - Variation EMEA/H/C/164/I/62
16/11/2000 Centralised - Variation EMEA/H/C/164/I/63
16/11/2000 Centralised - Variation EMEA/H/C/164/I/59
16/11/2000 Centralised - Variation EMEA/H/C/164/I/61
16/11/2000 Centralised - Variation EMEA/H/C/164/I/60
16/11/2000 Centralised - Variation EMEA/H/C/164/I/61
20/11/2000 Centralised - Variation EMEA/H/C/164/II/56 (2000)3245 of 16/11/2000
14/12/2000 Centralised - Variation EMEA/H/C/164/I/64
26/02/2001 Centralised - Variation EMEA/H/C/164/I/67
07/03/2001 Centralised - Variation EMEA/H/C/164/X/58 (2001)313 of 05/03/2001
05/04/2001 Centralised - Variation EMEA/H/C/164/II/65
13/06/2001 Centralised - Variation EMEA/H/C/164/II/57 (2001)1288 of 08/06/2001
13/06/2001 Centralised - Variation EMEA/H/C/164/II/67 (2001)1288 of 08/06/2001
21/06/2001 Centralised - Variation EMEA/H/C/164/I/69
21/06/2001 Centralised - Variation EMEA/H/C/164/I/70
21/06/2001 Centralised - Variation EMEA/H/C/164/I/68
20/07/2001 Centralised - Variation EMEA/H/C/164/I/73 (2001)2026 of 19/07/2001
03/08/2001 Centralised - Annual reassessment EMEA/H/C/164/S/72 (2001)2073 of 01/08/2001
17/10/2001 Centralised - Variation EMEA/H/C/164/II/71 (2001)2849 of 16/10/2001
19/11/2001 Centralised - Variation EMEA/H/C/164/I/76
28/11/2001 Centralised - Variation EMEA/H/C/164/I/75/78
06/02/2002 Centralised - Variation EMEA/H/C/164/N/79 (2002)471 of 04/02/2002
08/02/2002 Centralised - Variation EMEA/H/C/164/I/77 (2002)484 of 05/02/2002
13/06/2002 Centralised - Variation EMEA/H/C/164/II/80 (2002)2212 of 11/06/2002
12/09/2002 Centralised - Variation EMEA/H/C/164/II/81 (2002)3387 of 10/09/2002
16/09/2002 Centralised - Variation EMEA/H/C/164/I/83
16/09/2002 Centralised - Variation EMEA/H/C/164/I/82
24/09/2002 Centralised - Variation EMEA/H/C/164/I/86
24/09/2002 Centralised - Variation EMEA/H/C/164/I/84
24/09/2002 Centralised - Variation EMEA/H/C/164/I/85
05/02/2003 Centralised - Renewal EMEA/H/C/164/R/87 (2003)466 of 03/02/2003
03/07/2003 Centralised - Variation EMEA/H/C/164/II/88 (2003)2220 of 30/06/2003
02/10/2003 Centralised - Variation EMEA/H/C/164/I/91
02/10/2003 Centralised - Variation EMEA/H/C/164/I/92
29/01/2004 Centralised - Variation EMEA/H/C/164/II/90 (2004)233 of 27/01/2004
30/04/2004 Centralised - Variation EMEA/H/C/164/X/89 (2004)1772 of 28/04/2004
22/10/2004 Centralised - Variation EMEA/H/C/164/II/93 (2004)4189 of 20/10/2004
22/12/2004 Centralised - Variation EMEA/H/C/164/II/94 (2004)5394 of 17/12/2004
14/06/2005 Centralised - Variation EMEA/H/C/164/II/95 (2005)1800 of 10/06/2005
27/07/2005 Centralised - Variation EMEA/H/C/164/IA/96
16/11/2005 Centralised - Variation EMEA/H/C/164/IA/98
Updated with Decision(2006)685 of 28/02/2006
21/12/2005 Centralised - Variation EMEA/H/C/164/IB/99
02/03/2006 Centralised - Variation EMEA/H/C/164/II/97 (2006)685 of 28/02/2006
07/06/2006 Centralised - Variation EMEA/H/C/164/IB/100
Updated with Decision(2006)7015 of 18/12/2006
24/10/2006 Centralised - Variation EMEA/H/C/164/IA/102
Updated with Decision(2006)7015 of 18/12/2006
20/12/2006 Centralised - Variation (2006)7015 of 18/12/2006
15/01/2007 Centralised - Variation EMEA/H/C/164/II/103 (2007)119 of 11/01/2007
27/04/2007 Centralised - Variation EMEA/H/C/164/IA/104
Updated with Decision(2007)5230 of 19/10/2007
08/08/2007 Referral EMEA/H/C/164/A-20/107 (2007)3865 of 06/08/2007
18/10/2007 Centralised - Lift of suspension EMEA/H/C/164/Z/109 (2007)5144 of 15/10/2007
23/10/2007 Centralised - Variation EMEA/H/C/164/II/106, 105 (2007)5230 of 19/10/2007
14/01/2008 Centralised - Renewal EMEA/H/C/164/R/108 (2008)78 of 10/01/2008
30/01/2008 Centralised - Variation EMEA/H/C/164/II/110
24/06/2008 Centralised - Variation EMEA/H/C/164/II/111 (2008)3155 of 20/06/2008
30/07/2008 Centralised - Variation EMEA/H/C/164/IA/114
Updated with Decision(2009)1354 of 24/02/2009
30/07/2008 Centralised - Variation EMEA/H/C/164/II/112 (2008)4110 of 28/07/2008
29/01/2009 Centralised - Variation EMEA/H/C/164/IB/117
26/02/2009 Centralised - Variation (2009)1354 of 24/02/2009
07/07/2009 Centralised - Variation EMEA/H/C/164/IB/118
22/01/2010 Centralised - Variation EMEA/H/C/164/II/16 (2010)410 of 20/01/2010
01/06/2011 Centralised - Variation EMEA/H/C/164/II/120 (2011)3869 of 27/05/2011
07/09/2011 Centralised - Variation EMEA/H/C/164/II/119 (2011)6375 of 05/09/2011
22/03/2012 Centralised - Variation EMEA/H/C/164/N/121
Updated with Decision(2012)4481 of 27/06/2012
29/06/2012 Centralised - Variation EMEA/H/C/164/II/122 (2012)4481 of 27/06/2012
26/11/2012 Corrigendum
23/01/2013 Centralised - Withdrawal
02/08/2013 Rectificative Decision EMEA/H/C/164/II/122 (2013)4700 of 17/07/2013