Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Viramune   
Auth. number : EU/1/97/055
INN : nevirapine
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: J05AG01 - Nevirapine
(See WHO ATC Index)
Indication: Viramune is indicated in combination with other anti-retroviral medicinal products for the treatment of HIV-1 infected adults, adolescents, and children of any age (see section 4.4).
Most of the experience with Viramune is in combination with nucleoside reverse transcriptase inhibitors (NRTIs). The choice of a subsequent therapy after Viramune should be based on clinical experience and resistance testing (see section 5.1).
Marketing Authorisation Holder: Boehringer Ingelheim International GmbH
Binger Straße 173, D-55216 Ingelheim am Rhein, Deutschland

  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
10/02/1998 Centralised - Authorisation EMEA/H/C/183 (1998)255 of 05/02/1998
16/06/1998 Centralised - Variation EMEA/H/C/183/I/1 (1998)1604 of 15/06/1998
28/01/1999 Centralised - Variation EMEA/H/C/183/II/3 (1999)150 of 26/01/1999
03/06/1999 Centralised - Variation EMEA/H/C/183/X/2 (1999)1650 of 18/06/1999
19/07/1999 Centralised - Variation EMEA/H/C/183/II/7 (1999)1912 of 08/07/1999
05/08/1999 Centralised - Annual reassessment EMEA/H/C/183/S/9 (1999)2545 of 29/07/1999
17/01/2000 Centralised - Variation EMEA/H/C/183/I/13 (1999)5137 of 28/12/1999
20/03/2000 Centralised - Variation EMEA/H/C/183/II/11, 12 (2000)723 of 16/03/2000
07/08/2000 Centralised - Annual reassessment EMEA/H/C/183/S/14 (2000)2326 of 27/07/2000
31/10/2000 Centralised - Variation EMEA/H/C/183/II/15 (2000)2873 of 30/10/2000
20/11/2000 Centralised - Variation EMEA/H/C/183/II/16, 18 (2000)3250 of 15/11/2000
04/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/I/20
14/08/2001 Centralised - Annual reassessment EMEA/H/C/183/S/20 (2001)2114 of 13/08/2001
30/11/2001 Centralised - Variation EMEA/H/C/183/II/22, 23, 24 (2001)3891 of 30/11/2001
18/12/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/II/27
30/04/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/II/25
15/07/2002 Centralised - Annual reassessment EMEA/H/C/183/S/28 (2002)2753 of 11/07/2002
07/10/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/II/29
09/12/2002 Centralised - Variation EMEA/H/C/183/II/30, 31 (2002)4990 of 05/12/2002
19/02/2003 Centralised - Renewal EMEA/H/C/183/R/32 (2003)609 of 17/02/2003
22/05/2003 Centralised - Variation EMEA/H/C/183/I/34 (2003)1723 of 19/05/2003
25/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/I/36, 37
01/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/II/35
15/07/2003 Centralised - Variation EMEA/H/C/183/II/33 (2003)2549 of 09/07/2003
06/02/2004 Centralised - Variation EMEA/H/C/183/II/38 (2004)368 of 04/02/2004
28/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IA/41
08/06/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/II/40
15/07/2004 Centralised - Variation EMEA/H/C/183/II/39 (2004)2799 of 13/07/2004
30/07/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IB/42
25/08/2004 Centralised - Variation EMEA/H/C/183/IA/44
Updated with Decision(2004)4124 of 15/10/2004
19/10/2004 Centralised - Variation EMEA/H/C/183/II/43 (2004)4124 of 15/10/2004
17/11/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IA/46
07/01/2005 Centralised - Variation EMEA/H/C/183/II/45 (2005)23 of 05/01/2005
21/03/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/II/48
22/04/2005 Centralised - Variation EMEA/H/C/183/II/49 (2005)1294 of 20/04/2005
20/05/2005 Centralised - Variation EMEA/H/C/183/IB/50
Updated with Decision(2005)4493 of 15/11/2005
15/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/II/47
12/07/2005 Centralised - Variation EMEA/H/C/183/IB/51
Updated with Decision(2005)4493 of 15/11/2005
12/07/2005 Centralised - Variation EMEA/H/C/183/IB/52
Updated with Decision(2005)4493 of 15/11/2005
20/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IA/57
20/08/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IA/56
18/11/2005 Centralised - Variation EMEA/H/C/183/II/55 (2005)4493 of 15/11/2005
02/06/2006 Centralised - Variation EMEA/H/C/183/II/53, 54 (2006)2219 of 31/05/2006
14/08/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/II/59
06/09/2006 Centralised - Variation EMEA/H/C/183/II/58 (2006)4058 of 01/09/2006
31/10/2006 Centralised - Variation EMEA/H/C/183/II/60, 61 (2006)5250 of 27/10/2006
18/01/2007 Centralised - Variation EMEA/H/C/183/II/62 (2007)162 of 15/01/2007
30/03/2007 Centralised - Variation EMEA/H/C/183/IA/70
Updated with Decision(2007)2358 of 30/05/2007
12/04/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IA/71
16/04/2007 Centralised - Variation EMEA/H/C/183/IB/69
Updated with Decision(2007)2358 of 30/05/2007
04/05/2007 Centralised - Variation EMEA/H/C/183/II/63, 64 (2007)2020 of 02/05/2007
17/05/2007 Centralised - Variation EMEA/H/C/183/IA/72
Updated with Decision(2007)3289 of 29/06/2007
01/06/2007 Centralised - Variation EMEA/H/C/183/II/67 (2007)2358 of 30/05/2007
05/07/2007 Centralised - Variation EMEA/H/C/183/II/65, 66, 68 (2007)3289 of 29/06/2007
20/07/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IB/73
14/01/2008 Centralised - Renewal EMEA/H/C/183/R/74 (2008)76 of 10/01/2008
04/09/2008 Centralised - Variation EMEA/H/C/183/II/76 (2008)4954 of 02/09/2008
26/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IB/87
26/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IB/86
26/09/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IB/85
27/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/II/84
29/01/2009 Centralised - Variation EMEA/H/C/183/II/75 (2009)590 of 27/01/2009
05/03/2009 Centralised - Variation EMEA/H/C/183/IB/89
Updated with Decision(2009)3816 of 07/05/2009
11/05/2009 Centralised - Variation EMEA/H/C/183/II/88 (2009)3816 of 07/05/2009
03/06/2009 Centralised - Variation EMEA/H/C/183/II/82,83 (2009)4343 of 29/05/2009
04/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IA/90
08/01/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IB/91
26/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IA/92
26/04/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IA/93
30/08/2010 Centralised - Variation EMEA/H/C/183/II/94 (2010)6005 of 26/08/2010
04/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IA/97/G
25/01/2011 Centralised - Variation (no change in Commission Decision) EMEA/H/C/183/IB/96/G
28/06/2011 Centralised - Variation EMEA/H/C/183/II/98 (2011)4638 of 23/06/2011
26/09/2011 Centralised - Variation EMEA/H/C/183/X/95 (2011)6592 of 16/09/2011
26/10/2011 Corrigendum EMEA/H/C/183/X/95 (2011)7780 of 24/10/2011
23/01/2012 Centralised - Variation EMEA/H/C/183/IB/103
Updated with Decision(2012)6020 of 23/08/2012
17/04/2012 Centralised - Variation EMEA/H/C/183/X/95 (2012)2536 of 13/04/2012
27/08/2012 Centralised - Variation (2012)6020 of 23/08/2012
27/12/2012 Centralised - Renewal EMEA/H/C/183/R/106 (2012)9935 of 20/12/2012
19/04/2013 Centralised - Variation EMEA/H/C/183/IB/109
Updated with Decision(2014)2590 of 10/04/2014
25/06/2013 Centralised - Variation EMEA/H/C/183/IB/110
Updated with Decision(2014)2590 of 10/04/2014
25/07/2013 Centralised - Variation EMEA/H/C/183/II/108
Updated with Decision(2014)2590 of 10/04/2014
21/11/2013 Centralised - Variation EMEA/H/C/183/II/114
Updated with Decision(2014)2590 of 10/04/2014
21/11/2013 Centralised - Variation EMEA/H/C/183/II/113
Updated with Decision(2014)2590 of 10/04/2014
14/04/2014 Centralised - Yearly update (2014)2590 of 10/04/2014
16/07/2014 Centralised - Variation EMEA/H/C/183/IB/118
24/07/2014 Centralised - Variation EMEA/H/C/183/II/112