Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Fortovase
Auth. number : EU/1/98/075
INN : 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: In combination with antiretroviral agents indicated for the treatment of HIV-1 infected adult patients
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
24/08/1998 Centralised - Authorisation EMEA/H/C/178 (1998)2498 of 20/08/1998
08/04/1999 Centralised - Variation EMEA/H/C/178/II/1 (1999)836 of 29/03/1999
01/12/1999 Centralised - Variation EMEA/H/C/178/II/7 (1999)3845 of 29/11/1999
24/07/2000 Centralised - Variation EMEA/H/C/178/I/9, 10
19/10/2000 Centralised - Variation EMEA/H/C/178/II/8 (2000)2828 of 13/10/2000
24/01/2001 Centralised - Variation EMEA/H/C/178/II/11 (2001)46 of 22/01/2001
08/02/2001 Centralised - Variation EMEA/H/C/178/I/12
07/01/2002 Centralised - Variation EMEA/H/C/178/I/14
07/01/2002 Centralised - Variation EMEA/H/C/178/I/15
23/04/2002 Centralised - Variation EMEA/H/C/178/I/17, 20
27/08/2002 Centralised - Variation EMEA/H/C/178/II/16 (2002)3174 of 22/08/2002
15/10/2002 Centralised - Variation EMEA/H/C/178/II/21 (2002)3939 of 10/10/2002
23/01/2003 Centralised - Variation EMEA/H/C/178/I/22
15/07/2003 Centralised - Variation EMEA/H/C/178/II/23 (2003)2554 of 09/07/2003
10/09/2003 Centralised - Renewal EMEA/H/C/178/R/24 (2003)3277 of 08/09/2003
15/10/2003 Centralised - Variation EMEA/H/C/178/I/26
03/02/2004 Centralised - Variation EMEA/H/C/178/II/25 (2004)299 of 30/01/2004
29/06/2004 Centralised - Variation EMEA/H/C/178/N/28
Updated with Decision(2004)3484 of 09/09/2004
13/09/2004 Centralised - Variation EMEA/H/C/178/II/27 (2004)3484 of 09/09/2004
17/11/2004 Centralised - Variation EMEA/H/C/178/IA/30
12/01/2005 Centralised - Variation EMEA/H/C/178/II/29 (2005)66 of 10/01/2005
03/06/2005 Centralised - Variation EMEA/H/C/178/IA/32
11/07/2005 Centralised - Variation EMEA/H/C/178/II/31 (2005)2736 of 08/07/2005
26/08/2005 Centralised - Variation EMEA/H/C/178/II/33 (2005)3274 of 24/08/2005
30/09/2005 Centralised - Variation EMEA/H/C/178/IA/35
12/10/2005 Centralised - Variation EMEA/H/C/178/IA/36
Updated with Decision(2005)6020 of 23/12/2005
03/01/2006 Centralised - Variation EMEA/H/C/178/II/34 (2005)6020 of 23/12/2005
28/06/2006 Centralised - Withdrawal (2006)3022 of 26/06/2006