Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Vfend   
Auth. number : EU/1/02/212
INN : voriconazole
ATC: Anatomical main group: J - General antiinfectives for systemic use
Therapeutic subgroup: J02 - Antimycotics for systemic use
Pharmacological subgroup: J02A - Antimycotics for systemic use
Chemical subgroup: J02AC - Triazole derivatives
Chemical substance: J02AC03 - Voriconazole
(See WHO ATC Index)
Indication: Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated as follows:Treatment of invasive aspergillosis.Treatment of candidemia in non-neutropenic patients.Treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei).Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp.VFEND should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.
Marketing Authorisation Holder: Pfizer Limited
Ramsgate Road, Sandwich, Kent CT13 9NJ, 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
21/03/2002 Centralised - Authorisation EMEA/H/C/387 (2002)1236 of 19/03/2002
02/08/2002 Centralised - Variation EMEA/H/C/387/I/1
02/08/2002 Centralised - Variation EMEA/H/C/387/I/2
02/08/2002 Centralised - Variation EMEA/H/C/387/I/3
02/08/2002 Centralised - Variation EMEA/H/C/387/I/4
07/10/2002 Centralised - Variation EMEA/H/C/387/N/5 (2002)3712 of 03/10/2002
31/01/2003 Centralised - Variation EMEA/H/C/387/I/7, 8
27/02/2003 Centralised - Variation EMEA/H/C/387/I/6 (2003)682 of 24/02/2003
15/07/2003 Centralised - Variation EMEA/H/C/387/N/10 (2003)2537 of 09/07/2003
13/08/2003 Centralised - Variation EMEA/H/C/387/I/15
18/09/2003 Centralised - Variation EMEA/H/C/387/I/14 (2003)3347 of 16/09/2003
17/10/2003 Centralised - Variation EMEA/H/C/387/I/17
28/10/2003 Centralised - Variation EMEA/H/C/387/II/11, 12, 13 (2003)4026 of 24/10/2003
15/12/2003 Centralised - Variation EMEA/H/C/387/IB/16
Updated with Decision(2004)2087 of 08/06/2004
26/02/2004 Centralised - Variation EMEA/H/C/387/X/9 (2004)627 of 23/02/2004
26/03/2004 Centralised - Variation EMEA/H/C/387/IA/22
03/06/2004 Centralised - Variation EMEA/H/C/387/IA/23
10/06/2004 Centralised - Variation EMEA/H/C/387/II/18 (2004)2087 of 08/06/2004
11/06/2004 Centralised - Variation EMEA/H/C/387/II/19 (2004)2103 of 09/06/2004
13/08/2004 Centralised - Variation EMEA/H/C/387/II/21 (2004)3161 of 11/08/2004
15/11/2004 Centralised - Variation EMEA/H/C/387/II/24 (2004)4394 of 09/11/2004
12/01/2005 Centralised - Variation EMEA/H/C/387/II/20 (2005)102 of 10/01/2005
27/01/2005 Centralised - Variation EMEA/H/C/387/IA/27
31/03/2005 Centralised - Variation EMEA/H/C/387/II/25 (2005)1064 of 29/03/2005
22/04/2005 Centralised - Variation EMEA/H/C/387/IA/29
22/04/2005 Centralised - Variation EMEA/H/C/387/IA/28
09/06/2005 Centralised - Variation EMEA/H/C/387/IB/31
01/09/2005 Centralised - Variation EMEA/H/C/387/IB/32
Updated with Decision(2005)4291 of 27/10/2005
31/10/2005 Centralised - Variation EMEA/H/C/387/II/26 (2005)4291 of 27/10/2005
11/11/2005 Centralised - Variation EMEA/H/C/387/IB/33
02/02/2006 Centralised - Variation EMEA/H/C/387/II/34, 35 (2006)302 of 31/01/2006
02/06/2006 Centralised - Variation EMEA/H/C/387/II/36 (2006)2231 of 31/05/2006
01/08/2006 Centralised - Variation EMEA/H/C/387/II/41
31/08/2006 Centralised - Variation EMEA/H/C/387/II/38 (2006)3936 of 28/08/2006
30/10/2006 Centralised - Variation EMEA/H/C/387/II/39 (2006)5214 of 26/10/2006
15/12/2006 Centralised - Variation EMEA/H/C/387/IA/43
16/04/2007 Centralised - Variation EMEA/H/C/387/IA/50
16/04/2007 Centralised - Variation EMEA/H/C/387/IA/49
04/05/2007 Centralised - Renewal EMEA/H/C/387/R/42 (2007)2006 of 02/05/2007
08/05/2007 Centralised - Variation EMEA/H/C/387/IB/48
06/06/2007 Centralised - Variation EMEA/H/C/387/II/47
10/07/2007 Centralised - Variation EMEA/H/C/387/N/51
Updated with Decision(2008)413 of 28/01/2008
10/07/2007 Centralised - Variation EMEA/H/C/387/N/52
Updated with Decision(2008)413 of 28/01/2008
11/07/2007 Centralised - Variation EMEA/H/C/387/II/45, 46 (2007)3403 of 09/07/2007
03/09/2007 Centralised - Variation EMEA/H/C/387/N/53
Updated with Decision(2008)413 of 28/01/2008
16/11/2007 Centralised - Variation EMEA/H/C/387/IB/55
30/01/2008 Centralised - Variation EMEA/H/C/387/II/54 (2008)413 of 28/01/2008
15/02/2008 Centralised - Variation EMEA/H/C/387/IA/58
04/03/2008 Centralised - Variation EMEA/H/C/387/IA/59
24/06/2008 Centralised - Variation EMEA/H/C/387/II/56 (2008)3197 of 20/06/2008
14/10/2008 Centralised - Variation EMEA/H/C/387/IA/60
Updated with Decision(2009)754 of 02/02/2009
05/02/2009 Centralised - Variation EMEA/H/C/387/II/61 (2009)754 of 02/02/2009
20/05/2009 Centralised - Variation EMEA/H/C/387/IB/62
21/07/2009 Centralised - Variation EMEA/H/C/387/IB/66
28/07/2009 Centralised - Variation EMEA/H/C/387/IB/67
12/08/2009 Centralised - Variation EMEA/H/C/387/IA/69
12/08/2009 Centralised - Variation EMEA/H/C/387/IA/70
12/08/2009 Centralised - Variation EMEA/H/C/387/IA/68
13/08/2009 Centralised - Variation EMEA/H/C/387/IB/65
01/09/2009 Centralised - Variation EMEA/H/C/387/II/63 (2009)6710 of 27/08/2009
05/02/2010 Centralised - Variation EMEA/H/C/387/IB/72
05/02/2010 Centralised - Variation EMEA/H/C/387/IB/71
06/09/2010 Centralised - Variation EMEA/H/C/387/II/73 (2010)6133 of 01/09/2010
20/09/2010 Centralised - Variation EMEA/H/C/387/IA/76/G
Updated with Decision(2010)8641 of 29/11/2010
22/09/2010 Centralised - Variation EMEA/H/C/387/IB/77
06/12/2010 Centralised - Variation EMEA/H/C/387/II/74 (2010)8641 of 29/11/2010
23/12/2010 Centralised - Variation EMEA/H/C/387/II/75 (2010)9646 of 20/12/2010
30/08/2011 Centralised - Variation EMEA/H/C/387/II/78 (2011)6155 of 24/08/2011
15/11/2011 Centralised - Variation EMEA/H/C/387/II/80 (2011)8249 of 10/11/2011
19/12/2011 Centralised - Variation EMEA/H/C/387/II/83 (2011)9761 of 14/12/2011
23/02/2012 Centralised - Renewal EMEA/H/C/387/II/79, EMEA/H/C/387/R/82 (2012)1267 of 21/02/2012
25/04/2012 Centralised - Variation EMEA/H/C/387/II/84 (2012)2849 of 20/04/2012
03/07/2012 Centralised - Variation EMEA/H/C/387/II/86 (2012)4602 of 28/06/2012
28/08/2012 Centralised - Variation EMEA/H/C/387/II/90 (2012)6029 of 23/08/2012
28/08/2012 Centralised - Variation EMEA/H/C/387/II/89 (2012)6028 of 23/08/2012
14/11/2012 Centralised - Variation EMEA/H/C/387/II/91, 88/G (2012)7909 of 29/10/2012
25/04/2013 Centralised - Variation EMEA/H/C/387/II/94
Updated with Decision(2014)2804 of 23/04/2014
27/06/2013 Centralised - Variation EMEA/H/C/387/II/95
Updated with Decision(2014)2804 of 23/04/2014
24/10/2013 Centralised - Variation EMEA/H/C/387/II/98
Updated with Decision(2014)2804 of 23/04/2014
27/10/2013 Centralised - Variation EMEA/H/C/387/N/99
Updated with Decision(2014)2804 of 23/04/2014
23/01/2014 Centralised - Variation EMEA/H/C/387/II/100
Updated with Decision(2014)2804 of 23/04/2014
28/04/2014 Centralised - Variation (2014)2804 of 23/04/2014
25/06/2014 Centralised - Variation EMEA/H/C/387/II/97 (2014)4357 of 23/06/2014
19/08/2014 Centralised - Variation EMEA/H/C/387/N/104