Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Crixivan   
Auth. number : EU/1/96/024
Active substance : Indinavir
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: J05AE02 - Indinavir
(See WHO ATC Index)
Indication: CRIXIVAN is indicated in combination with antiretroviral nucleoside analogues for the treatment of HIV–1 infected adults.
Marketing Authorisation Holder: Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire EN11 9BU, 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
07/10/1996 Centralised - Authorisation EMEA/H/C/128 (96)2726 of 04/10/1996
10/04/1997 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/2
17/06/1997 Centralised - Variation EMEA/H/C/128/I/1 (97)1715 of 13/06/1997
28/08/1997 Centralised - Variation EMEA/H/C/128/II/3 (97)2747 of 27/08/1997
02/10/1997 Centralised - Notification EMEA/H/C/128/N/4 (97)2947 of 01/10/1997
23/01/1998 Centralised - Variation EMEA/H/C/128/II/4 (1998)172 of 22/01/1998
26/02/1998 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/8,9,10,12,15
04/03/1998 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/11
20/03/1998 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/17
09/04/1998 Centralised - Annual reassessment EMEA/H/C/128/S/6 (1998)936 of 08/04/1998
30/04/1998 Centralised - Variation EMEA/H/C/128/II/7 (1998)1126 of 29/04/1998
14/05/1998 Centralised - Variation EMEA/H/C/128/I/13, 14 (1998)1323 of 13/05/1998
16/06/1998 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/18
25/06/1998 Centralised - Variation EMEA/H/C/128/II/16 (1998)1721 of 24/06/1998
05/11/1998 Centralised - Variation EMEA/H/C/128/II/19 (1998)3391 of 29/10/1998
11/11/1998 Centralised - Authorisation EMEA/H/C/128/II/20 (1998)3491 of 06/11/1998
26/02/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/24
15/04/1999 Centralised - Authorisation EMEA/H/C/128/X/21 (1999)937 of 13/04/1999
21/04/1999 Centralised - Variation EMEA/H/C/128/II/22 (1999)1004 of 19/04/1999
21/04/1999 Centralised - Variation EMEA/H/C/128/II/23 (1999)691 of 12/03/1999
10/09/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/II/26
14/09/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/29
14/12/1999 Centralised - Variation EMEA/H/C/128/I/28 (1999)4184 of 08/12/1999
15/12/1999 Centralised - Variation EMEA/H/C/128/II/25, 27 (1999)4274 of 08/12/1999
21/12/1999 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/31
15/02/2000 Centralised - Variation EMEA/H/C/128/I/30 (2000)179 of 08/02/2000
23/02/2000 Centralised - Variation EMEA/H/C/128/I/32 (2000)419 of 21/02/2000
15/05/2000 Centralised - Variation EMEA/H/C/128/II/33 (2000)1201 of 11/05/2000
15/05/2000 Centralised - Variation EMEA/H/C/128/I/34, 35 (2000)1200 of 11/05/2000
18/07/2000 Centralised - Variation EMEA/H/C/128/II/38 (2000)1753 of 05/07/2000
20/11/2000 Centralised - Variation EMEA/H/C/128/X/36 (2000)3246 of 16/11/2000
18/12/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/39
30/01/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/42
13/03/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/II/41
06/04/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/45
13/06/2001 Centralised - Variation EMEA/H/C/128/II/40 (2001)1287 of 08/06/2001
06/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/46
06/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/48
06/07/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/47
23/11/2001 Centralised - Renewal EMEA/H/C/128/R/49 (2001)3599 of 21/11/2001
25/03/2002 Centralised - Variation EMEA/H/C/125/II/50 (2002)1272 of 21/03/2002
07/06/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/II/51
15/07/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/53
17/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/56
17/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/55
17/09/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/54
21/10/2002 Centralised - Variation EMEA/H/C/128/II/52 (2002)4063 of 17/10/2002
13/05/2003 Centralised - Variation EMEA/H/C/128/II/57 (2003)1572 of 08/05/2003
26/06/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/I/59
30/06/2003 Centralised - Variation EMEA/H/C/128/II/58 (2003)2120 of 26/06/2003
07/10/2003 Centralised - Variation EMEA/H/C/128/I/61 (2003)3608 of 03/10/2003
03/02/2004 Centralised - Variation EMEA/H/C/128/II/60 (2004)303 of 30/01/2004
26/03/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/IA/62
25/05/2004 Centralised - Notification EMEA/H/C/128/N/63
Updated with Decision(2004)3481 of 09/09/2004
10/09/2004 Centralised - Variation EMEA/H/C/128/IA/65
Updated with Decision(2005)11 of 05/01/2005
13/09/2004 Centralised - Variation EMEA/H/C/128/II/64 (2004)3481 of 09/09/2004
07/01/2005 Centralised - Variation EMEA/H/C/128/II/66 (2005)11 of 05/01/2005
03/08/2005 Centralised - Variation EMEA/H/C/128/II/67 (2005)3042 of 01/08/2005
22/11/2006 Centralised - Renewal EMEA/H/C/128/R/68 (2006)5663 of 20/11/2006
26/01/2007 Centralised - Variation EMEA/H/C/128/II/69, 70 (2007)265 of 24/01/2007
08/05/2007 Centralised - Variation EMEA/H/C/128/II/72 (2007)2039 of 03/05/2007
26/07/2007 Centralised - Variation EMEA/H/C/128/II/73, 74 (2007)3644 of 24/07/2007
13/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/IA/77
19/12/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/IB/76
24/06/2008 Centralised - Variation EMEA/H/C/128/II/75, 71 (2008)3148 of 20/06/2008
03/09/2008 Centralised - Notification EMEA/H/C/128/N/79
Updated with Decision(2008)6532 of 29/10/2008
31/10/2008 Centralised - Variation EMEA/H/C/128/II/78 (2008)6532 of 29/10/2008
16/02/2009 Centralised - Variation EMEA/H/C/128/IA/80
Updated with Decision(2009)5744 of 14/07/2009
16/07/2009 Centralised - Variation EMEA/H/C/128/II/82 (2009)5744 of 14/07/2009
28/07/2009 Corrigendum EMEA/H/C/128/II/82 (2009)5744 cor of 14/07/2009
28/07/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/IA/83
24/12/2009 Centralised - Variation EMEA/H/C/128/II/81 (2009)10750 of 22/12/2009
13/04/2010 Centralised - Variation EMEA/H/C/128/IA/84
Updated with Decision(2010)5628 of 06/08/2010
25/05/2010 Centralised - Variation EMEA/H/C/128/IB/85
Updated with Decision(2010)5628 of 06/08/2010
15/06/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/128/IA/86/G
12/08/2010 Centralised - Variation (2010)5628 of 06/08/2010
18/11/2010 Centralised - Variation EMEA/H/C/128/IG/27/G
Updated with Decision(2011)971 of 11/02/2011
15/02/2011 Centralised - Variation (2011)971 of 11/02/2011
20/07/2011 Centralised - Renewal EMEA/H/C/128/R/87 (2011)5302 of 18/07/2011
10/02/2012 Centralised - Variation EMEA/H/C/128/IB/88/G
Updated with Decision(2012)6140 of 30/08/2012
03/09/2012 Centralised - Variation (2012)6140 of 30/08/2012
19/12/2012 Centralised - Notification EMEA/H/C/128/N/93
Updated with Decision(2014)636 of 31/01/2014
24/05/2013 Centralised - Variation EMEA/H/C/128/IB/95
Updated with Decision(2014)636 of 31/01/2014
31/05/2013 Centralised - Notification EMEA/H/C/128/N/94
Updated with Decision(2014)636 of 31/01/2014
04/02/2014 Centralised - 2-Monthly update EMEA/H/C/128/IB/97 (2014)636 of 31/01/2014
12/03/2014 Centralised - Variation EMEA/H/C/128/IB/98
Updated with Decision(2015)1742 of 11/03/2015
24/07/2014 Centralised - Variation EMEA/H/C/128/II/99
Updated with Decision(2015)1742 of 11/03/2015
13/03/2015 Centralised - Yearly update (2015)1742 of 11/03/2015