Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


WITHDRAWN  

Product information

Invented name: Vistide
Auth. number : EU/1/97/037
INN : Cidofovir
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: J05AB - Nucleosides
Chemical substance: J05AB12 - Cidofovir
(See WHO ATC Index)
Indication: Treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS) and without renal dysfunction. Should be used only when other agents are considered unsuitable.
Marketing Authorisation Holder: Gilead Sciences International Limited
Cambridge CB21 6GT, 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
12/05/1997 Centralised - Authorisation EMEA/H/C/121 (97)1176 of 23/04/1997
19/09/1997 Centralised - Variation EMEA/H/C/121/N/1 (97)2857 of 18/09/1997
20/10/1997 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/121/T/3 (97)3183 of 17/10/1997
06/11/1997 Centralised - Variation EMEA/H/C/121/N/2 (97)3370 of 05/11/1997
03/06/1998 Centralised - Variation EMEA/H/C/121/N/4 (1998)1462 of 02/06/1998
22/09/1998 Centralised - Variation EMEA/H/C/121/I/6 (1998)2695 of 18/09/1998
05/03/1999 Centralised - Variation EMEA/H/C/121/II/7 (1999)455 of 26/02/1999
14/07/1999 Centralised - Variation EMEA/H/C/121/II/8 (1999)1636 of 17/06/1999
20/07/2000 Centralised - Variation EMEA/H/C/121/II/9 (2000)2031 of 13/07/2000
19/11/2001 Centralised - Variation EMEA/H/C/121/I/12
22/02/2002 Centralised - Variation EMEA/H/C/121/I/10 (2002)637 of 19/02/2002
15/07/2002 Centralised - Renewal EMEA/H/C/121/R/13 (2002)2705 of 10/07/2002
19/03/2003 Centralised - Variation EMEA/H/C/121/II/14 (2003)855 of 17/03/2003
27/09/2004 Centralised - Variation EMEA/H/C/121/IA/15
Updated with Decision(2005)1975 of 24/06/2005
28/06/2005 Centralised - Variation (2005)1975 of 24/06/2005
27/11/2006 Centralised - Variation EMEA/H/C/121/II/16
12/06/2007 Centralised - Renewal EMEA/H/C/121/R/17 (2007)2558 of 08/06/2007
31/08/2007 Centralised - Variation EMEA/H/C/121/II/18 (2007)4101 of 29/08/2007
26/09/2007 Centralised - Variation EMEA/H/C/121/II/20
24/06/2008 Centralised - Variation EMEA/H/C/121/II/21 (2008)3201 of 20/06/2008
02/12/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/121/T/22 (2008)7855 of 28/11/2008
18/12/2008 Centralised - Variation EMEA/H/C/121/IA/25
18/12/2008 Centralised - Variation EMEA/H/C/121/IA/23
Updated with Decision(2009)5987 of 23/07/2009
18/12/2008 Centralised - Variation EMEA/H/C/121/IA/24
19/01/2009 Centralised - Variation EMEA/H/C/121/N/26
Updated with Decision(2009)5987 of 23/07/2009
07/04/2009 Centralised - Variation EMEA/H/C/121/IA/28
19/05/2009 Centralised - Variation EMEA/H/C/121/N/27
Updated with Decision(2009)5987 of 23/07/2009
28/07/2009 Centralised - Variation (2009)5987 of 23/07/2009
27/10/2009 Centralised - Variation EMEA/H/C/121/II/29 (2009)8395 of 23/10/2009
30/03/2010 Centralised - Variation EMEA/H/C/121/II/30 (2010)2158 of 26/03/2010
05/10/2010 Centralised - Variation EMEA/H/C/121/IB/31
08/11/2010 Centralised - Variation EMEA/H/C/121/IB/33/G
27/01/2011 Centralised - Variation EMEA/H/C/121/II/32 (2011)473 of 24/01/2011
02/05/2011 Centralised - Variation EMEA/H/C/121/N/34
14/12/2011 Referral EMEA/H/C/121/A-20/35 (2011)9513 of 12/12/2011
31/05/2012 Referral EMEA/H/C/121/A-20/35 (2012)3607 of 25/05/2012