Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Norvir   
Auth. number : EU/1/96/016
INN : Ritonavir
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: J05AE03 - Ritonavir
(See WHO ATC Index)
Indication: Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infected patients (adults and children of 2 years of age and older).
Marketing Authorisation Holder: AbbVie Ltd
Maidenhead, SL6 4XE, 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
27/08/1996 Centralised - Authorisation EMEA/H/C/127 (96)2432 of 26/08/1996
23/07/1997 Centralised - Variation EMEA/H/C/127/II/2 (97)2314 of 22/07/1997
01/10/1997 Centralised - Variation EMEA/H/C/127/II/3 (97)2921 of 30/09/1997
19/01/1998 Centralised - Variation EMEA/H/C/127/I/6 (1998)58 of 15/01/1998
19/01/1998 Centralised - Variation EMEA/H/C/127/I/7 (1998)59 of 15/01/1998
18/03/1998 Centralised - Variation EMEA/H/C/127/II/4, 5 (1998)670 of 17/03/1998
23/03/1998 Centralised - Annual reassessment EMEA/H/C/127/S/8 (1998)708 of 20/03/1998
14/01/1999 Centralised - Variation EMEA/H/C/127/1/II/12 (1999)36 of 11/01/1999
02/03/1999 Centralised - Annual reassessment EMEA/H/C/127/S/15 (1999)435 of 23/02/1999
05/03/1999 Centralised - Variation EMEA/H/C/127/II/10, 14, 16 (1999)456 of 26/02/1999
01/12/1999 Centralised - Authorisation EMEA/H/C/127/X/17 (1999)3954 of 29/11/1999
01/12/1999 Centralised - Variation EMEA/H/C/127/II/18 (1999)3953 of 29/11/1999
14/03/2000 Centralised - Annual reassessment EMEA/H/C/127/S/19 (2000)607 of 09/03/2000
29/03/2000 Centralised - Variation EMEA/H/C/127 (2000)778 of 24/03/2000
25/10/2000 Centralised - Variation EMEA/H/C/127/II/20 (2000)2859 of 20/10/2000
28/11/2000 Centralised - Variation EMEA/H/C/127/I/23
22/01/2001 Centralised - Variation EMEA/H/C/127/I/26
22/01/2001 Centralised - Variation EMEA/H/C/127/I/24
16/03/2001 Centralised - Authorisation EMEA/H/C/127/S/25 (2001)518 of 13/03/2001
15/06/2001 Centralised - Variation EMEA/H/C/127/II/21, 22 (2001)1319 of 14/06/2001
03/07/2001 Centralised - Variation EMEA/H/C/127/II/33
15/11/2001 Centralised - Renewal EMEA/H/C/127/R/29 (2001)3523 of 12/11/2001
28/11/2001 Centralised - Variation EMEA/H/C/127/II/27
20/12/2001 Centralised - Variation EMEA/H/C/127/I/34 (2001)4317 of 17/12/2001
04/03/2002 Centralised - Variation EMEA/H/C/127/I/35
12/09/2002 Centralised - Variation EMEA/H/C/127/II/36 (2002)3389 of 10/09/2002
10/10/2002 Centralised - Variation EMEA/H/C/127/I/40
10/10/2002 Centralised - Variation EMEA/H/C/127/I/38
10/10/2002 Centralised - Variation EMEA/H/C/127/I/41
10/10/2002 Centralised - Variation EMEA/H/C/127/I/37
10/10/2002 Centralised - Variation EMEA/H/C/127/I/39
11/11/2002 Centralised - Variation EMEA/H/C/127/N/43 (2002)4430 of 07/11/2002
16/07/2003 Centralised - Variation EMEA/H/C/127/II/44 (2003)2623 of 14/07/2003
18/08/2003 Centralised - Variation EMEA/H/C/127/I/46
09/10/2003 Centralised - Variation EMEA/H/C/127/I/47
29/01/2004 Centralised - Variation EMEA/H/C/127/II/45 (2004)235 of 27/01/2004
29/03/2004 Centralised - Variation EMEA/H/C/127/II/48 (2004)1203 of 25/03/2004
04/08/2004 Centralised - Variation EMEA/H/C/127/II/49 (2004)3046 of 02/08/2004
22/09/2004 Centralised - Variation EMEA/H/C/127/IA/50
Updated with Decision(2005)158 of 20/01/2005
24/01/2005 Centralised - Variation EMEA/H/C/127/II/51 (2005)158 of 20/01/2005
02/09/2005 Centralised - Variation EMEA/H/C/127/II/52 (2005)3398 of 31/08/2005
15/11/2005 Centralised - Variation EMEA/H/C/127/IA/53
09/12/2005 Centralised - Variation EMEA/H/C/127/IA/54
02/08/2006 Centralised - Variation EMEA/H/C/127/II/56 (2006)3541 of 28/07/2006
22/11/2006 Centralised - Renewal EMEA/H/C/127/R/55 (2006)5672 of 20/11/2006
01/12/2006 Centralised - Variation EMEA/H/C/127/IA/62
01/12/2006 Centralised - Variation EMEA/H/C/127/IA/64
01/12/2006 Centralised - Variation EMEA/H/C/127/IA/62
01/12/2006 Centralised - Variation EMEA/H/C/127/IA/63
01/12/2006 Centralised - Variation EMEA/H/C/127/IA/65
06/12/2006 Centralised - Variation EMEA/H/C/127/IA/67
Updated with Decision(2007)158 of 12/01/2007
16/01/2007 Centralised - Variation EMEA/H/C/127/II/60 (2007)158 of 12/01/2007
01/03/2007 Centralised - Variation EMEA/H/C/127/II/58 (2007)706 of 27/02/2007
24/04/2007 Centralised - Variation EMEA/H/C/127/IA/68
04/05/2007 Centralised - Variation EMEA/H/C/127/II/61 (2007)2019 of 02/05/2007
07/05/2007 Centralised - Variation EMEA/H/C/127/IB/69
21/05/2007 Centralised - Variation EMEA/H/C/127/IA/71
21/06/2007 Centralised - Variation EMEA/H/C/127/IA/73
14/08/2007 Centralised - Variation EMEA/H/C/127/II/70 (2007)3918 of 10/08/2007
22/11/2007 Centralised - Variation EMEA/H/C/127/II/72, 74 (2007)5697 of 20/11/2007
15/01/2008 Centralised - Variation EMEA/H/C/127/IA/80
28/01/2008 Centralised - Variation EMEA/H/C/127/IA/83
28/01/2008 Centralised - Variation EMEA/H/C/127/IA/82
07/02/2008 Centralised - Variation EMEA/H/C/127/IB/81
18/02/2008 Centralised - Variation EMEA/H/C/127/IB/84
31/03/2008 Centralised - Variation EMEA/H/C/127/II/78 (2008)1251 of 27/03/2008
14/05/2008 Centralised - Variation EMEA/H/C/127/IA/85
Updated with Decision(2008)8248 of 05/12/2008
13/06/2008 Centralised - Variation EMEA/H/C/127/IA/86
20/06/2008 Centralised - Variation EMEA/H/C/127/II/76, 79 (2008)3072 of 18/06/2008
05/11/2008 Centralised - Variation EMEA/H/C/127/IA/88
18/11/2008 Centralised - Variation EMEA/H/C/127/IB/87
09/12/2008 Centralised - Variation (2008)8248 of 05/12/2008
03/07/2009 Centralised - Variation EMEA/H/C/127/II/89 (2009)5402 of 01/07/2009
07/09/2009 Centralised - Variation EMEA/H/C/127/II/91 (2009)6830 of 02/09/2009
27/10/2009 Centralised - Variation EMEA/H/C/127/II/92 (2009)8401 of 23/10/2009
23/12/2009 Centralised - Variation EMEA/H/C/127/IA/94
Updated with Decision(2010)1787 of 15/03/2010
27/01/2010 Centralised - Variation EMEA/H/C/127/X/90 (2010)530 of 25/01/2010
17/03/2010 Centralised - Variation (2010)1787 of 15/03/2010
25/03/2010 Centralised - Variation EMEA/H/C/127/II/93 (2010)2032 of 23/03/2010
16/04/2010 Centralised - Variation EMEA/H/C/127/IB/96
Updated with Decision(2010)7717 of 03/11/2010
23/07/2010 Centralised - Variation EMEA/H/C/127/IG/14/G
Updated with Decision(2010)7717 of 03/11/2010
23/07/2010 Centralised - Variation EMEA/H/C/127/IA/97
23/07/2010 Centralised - Variation EMEA/H/C/127/IA/98
22/09/2010 Centralised - Variation EMEA/H/C/127/IG/22/G
Updated with Decision(2010)7717 of 03/11/2010
04/10/2010 Centralised - Variation EMEA/H/C/127/N/99
Updated with Decision(2010)7717 of 03/11/2010
25/10/2010 Centralised - Variation EMEA/H/C/127/IB/100
Updated with Decision(2011)4172 of 07/06/2011
08/11/2010 Centralised - Variation (2010)7717 of 03/11/2010
16/12/2010 Centralised - Variation EMEA/H/C/127/IA/102
24/01/2011 Centralised - Variation EMEA/H/C/127/IA/103
11/02/2011 Centralised - Variation EMEA/H/C/127/IB/101
Updated with Decision(2011)4172 of 07/06/2011
21/02/2011 Centralised - Variation EMEA/H/C/127/IB/104
01/04/2011 Centralised - Variation EMEA/H/C/127/IA/105
Updated with Decision(2011)4172 of 07/06/2011
09/06/2011 Centralised - Variation (2011)4172 of 07/06/2011
24/11/2011 Centralised - Variation EMEA/H/C/127/II/110 (2011)8691 of 22/11/2011
28/12/2011 Centralised - Variation EMEA/H/C/127/II/111 (2011)10104 of 22/12/2011
21/03/2012 Centralised - Variation EMEA/H/C/127/II/109 (2012)1916 of 19/03/2012
26/04/2012 Centralised - Variation EMEA/H/C/127/II/113 (2012)2857 of 20/04/2012
12/09/2012 Centralised - Variation EMEA/H/C/127/II/114, 115 (2012)6392 of 10/09/2012
26/10/2012 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/127/T/117 (2012)7663 of 24/10/2012
14/12/2012 Centralised - Variation EMEA/H/C/127/IG/240/G
Updated with Decision(2013)9728 of 18/12/2013
17/01/2013 Centralised - Variation EMEA/H/C/127/II/116
Updated with Decision(2013)9728 of 18/12/2013
23/01/2013 Centralised - Variation EMEA/H/C/127/N/119
Updated with Decision(2013)9728 of 18/12/2013
24/06/2013 Centralised - Variation EMEA/H/C/127/N/121
Updated with Decision(2013)9728 of 18/12/2013
20/12/2013 Centralised - Variation EMEA/H/C/127/II/122 (2013)9728 of 18/12/2013
25/03/2014 Centralised - Variation EMEA/H/C/127/IB/126