Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Invirase   
Auth. number : EU/1/96/026
Active substance : Saquinavir
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: J05AE01 - Saquinavir
(See WHO ATC Index)
Indication: Invirase is indicated for the treatment of HIV-1 infected adult patients. Invirase should only be given in combination with ritonavir and other antiretroviral medicinal products
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
04/10/1996 Centralised - Authorisation EMEA/H/C/113 (96)2724 of 04/10/1996
13/05/1998 Centralised - Variation EMEA/H/C/113/II/5 (1998)1305 of 12/05/1998
19/05/1998 Centralised - Renewal EMEA/H/C/113/S/4 (1998)1361 of 18/05/1998
26/11/1998 Centralised - Variation EMEA/H/C/113/I/10 (1998)3524 of 24/11/1998
08/03/1999 Centralised - Variation EMEA/H/C/113/II/14 (1999)446 of 25/02/1999
13/04/1999 Centralised - Renewal EMEA/H/C/113/S/13 (1999)895 of 08/04/1999
13/04/1999 Centralised - Variation EMEA/H/C/113/II/11 (1999)897 of 08/04/1999
01/12/1999 Centralised - Variation EMEA/H/C/113/II/16 (1999)3842 of 29/11/1999
29/03/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/I/17, 18, 19, 20, 21, 22
11/04/2000 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/I/23, 24, 25
03/08/2000 Centralised - Notification EMEA/H/C/113/N/28 (2000)2332 of 27/07/2000
25/10/2000 Centralised - Variation EMEA/H/C/113/II/26 (2000)2855 of 20/10/2000
02/01/2001 Centralised - Variation EMEA/H/C/113/II/27 (2000)3986 of 27/12/2000
04/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/II/29
10/05/2001 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/I/30
14/11/2001 Centralised - Renewal EMEA/H/C/113/R/31 (2001)3525 of 12/11/2001
12/09/2002 Centralised - Variation EMEA/H/C/113/II/32 (2002)3388 of 10/09/2002
15/07/2003 Centralised - Variation EMEA/H/C/113/II/33 (2003)2559 of 09/07/2003
15/10/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/I/35
29/01/2004 Centralised - Variation EMEA/H/C/113/II/34 (2004)225 of 27/01/2004
27/04/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/II/40
28/06/2004 Centralised - Notification EMEA/H/C/113/N/42
Updated with Decision(2004)3494 of 10/09/2004
14/09/2004 Centralised - Variation EMEA/H/C/113/II/41 (2004)3494 of 10/09/2004
22/12/2004 Centralised - Variation EMEA/H/C/113/II/44 (2004)5379 of 17/12/2004
13/04/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IA/46
26/05/2005 Centralised - Notification EMEA/H/C/113/N/47
Updated with Decision(2005)2087 of 28/06/2005
27/05/2005 Centralised - Variation EMEA/H/C/113/X/43 (2005)1612 of 25/05/2005
30/06/2005 Centralised - Variation EMEA/H/C/113/II/45 (2005)2087 of 28/06/2005
30/06/2005 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IA/48
02/09/2005 Centralised - Variation EMEA/H/C/113/II/49 (2005)3400 of 31/08/2005
16/11/2005 Centralised - Variation EMEA/H/C/113/IA/51
Updated with Decision(2005)6016 of 23/12/2005
03/01/2006 Centralised - Variation EMEA/H/C/113/II/50 (2005)6016 of 23/12/2005
29/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/II/52
23/05/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IA/54
13/10/2006 Centralised - Variation EMEA/H/C/113/II/56 (2006)4899 of 11/10/2006
31/10/2006 Centralised - Variation EMEA/H/C/113/II/55 (2006)5252 of 27/10/2006
24/11/2006 Centralised - Renewal EMEA/H/C/113/R/53 (2006)5730 of 22/11/2006
09/01/2007 Centralised - Variation EMEA/H/C/113/II/57 (2007)14 of 03/01/2007
15/01/2007 Centralised - Variation EMEA/H/C/113/II/59 (2007)120 of 11/01/2007
13/02/2007 Centralised - Variation EMEA/H/C/113/IA/61
Updated with Decision(2007)1538 of 29/03/2007
02/04/2007 Centralised - Variation EMEA/H/C/113/II/58 (2007)1538 of 29/03/2007
04/05/2007 Centralised - Variation EMEA/H/C/113/II/60 (2007)2018 of 02/05/2007
14/05/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IA/64
01/06/2007 Centralised - Variation EMEA/H/C/113/IB/63
Updated with Decision(2007)5229 of 19/10/2007
23/10/2007 Centralised - Variation EMEA/H/C/113/II/65, 66 (2007)5229 of 19/10/2007
29/10/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IA/68
23/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IA/69
30/01/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IB/70
03/07/2008 Centralised - Variation EMEA/H/C/113/IA/72
Updated with Decision(2008)6656 of 31/10/2008
09/07/2008 Centralised - Variation EMEA/H/C/113/II/62, 71 (2008)3556 of 07/07/2008
04/11/2008 Centralised - Variation EMEA/H/C/113/II/73 (2008)6656 of 31/10/2008
07/11/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IA/75
29/01/2009 Centralised - Variation EMEA/H/C/113/II/74 (2009)586 of 27/01/2009
08/04/2009 Centralised - Notification EMEA/H/C/113/N/76
Updated with Decision(2010)1793 of 15/03/2010
16/06/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IA/77
10/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IA/83
10/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IB/79
10/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IA/82
10/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IA/84
08/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IB/81
08/10/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IB/80
17/03/2010 Centralised - Variation EMEA/H/C/113/II/78 (2010)1793 of 15/03/2010
19/03/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IA/87
30/03/2010 Centralised - Variation EMEA/H/C/113/II/86 (2010)2157 of 26/03/2010
02/08/2010 Centralised - Variation EMEA/H/C/113/II/85 (2010)5390 of 28/07/2010
27/08/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IB/89/G
09/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/113/IA/90/G
31/12/2010 Referral EMEA/H/C/113/A-20/88 (2011)67 of 06/01/2011
28/06/2011 Centralised - Variation EMEA/H/C/113/113/II/91 (2011)4632 of 23/06/2011
24/11/2011 Centralised - Variation EMEA/H/C/113/II/94 (2011)8692 of 22/11/2011
06/03/2012 Centralised - Variation EMEA/H/C/113/II/93 (2012)1506 of 02/03/2012
29/06/2012 Centralised - Variation EMEA/H/C/113/II/95 (2012)4482 of 27/06/2012
26/10/2012 Centralised - Variation EMEA/H/C/113/II/97 (2012)7660 of 24/10/2012
17/01/2013 Centralised - Variation EMEA/H/C/113/II/98
Updated with Decision(2013)8065 of 13/11/2013
25/05/2013 Centralised - Variation EMEA/H/C/113/IB/101
Updated with Decision(2013)8065 of 13/11/2013
25/07/2013 Centralised - Variation EMEA/H/C/113/II/100
Updated with Decision(2013)8065 of 13/11/2013
15/11/2013 Centralised - 2-Monthly update EMEA/H/C/113/IB/103 (2013)8065 of 13/11/2013
24/03/2014 Centralised - Variation EMEA/H/C/113/IB/107/G
Updated with Decision(2015)1563 of 05/03/2015
06/05/2014 Centralised - 2-Monthly update EMEA/H/C/113/II/104 (2014)3041 of 02/05/2014
09/03/2015 Centralised - Yearly update (2015)1563 of 05/03/2015