Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: CANCIDAS   
Auth. number : EU/1/01/196
INN : caspofungin
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: J02AX - Other antimycotics for systemic use
Chemical substance: J02AX04 - Caspofungin
(See WHO ATC Index)
Indication: - Treatment of invasive candidiasis in adult or paediatric patients.- Treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and/or itraconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum of 7 days of prior therapeutic doses of effective antifungal therapy.- Empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.
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
24/10/2001 Centralised - Authorisation EMEA/H/C/379 (2001)2898 of 24/10/2001
29/08/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/I/4
29/08/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/I/3
07/10/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/I/7
12/11/2002 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/I/5, 6, 8
19/02/2003 Centralised - Variation EMEA/H/C/379/II/2 (2003)613 of 17/02/2003
26/02/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/I/9, 10
11/04/2003 Centralised - Variation EMEA/H/C/379/I/13 (2003)1257 of 09/04/2003
22/05/2003 Centralised - Annual reassessment EMEA/H/C/379/S/12 (2003)1725 of 19/05/2003
18/07/2003 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/I/14
09/02/2004 Centralised - Variation EMEA/H/C/379/II/15, 16 (2004)410 of 05/02/2004
19/02/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/IB/19
13/05/2004 Centralised - Annual reassessment EMEA/H/C/379/S/18 (2004)1875 of 11/05/2004
17/05/2004 Centralised - Variation EMEA/H/C/379/II/17 (2004)1876 of 13/05/2004
19/05/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/IA/21
10/09/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/IB/23
13/10/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/IB/22
28/10/2004 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/II/25
01/11/2004 Centralised - Variation EMEA/H/C/379/II/20 (2004)4300 of 28/10/2004
13/05/2005 Centralised - Annual reassessment EMEA/H/C/379/S/26 (2005)1475 of 10/05/2005
28/03/2006 Centralised - Annual reassessment EMEA/H/C/379/S/27 (2006)1170 of 23/03/2006
28/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/IA/29
29/03/2006 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/II/28
03/10/2006 Centralised - Renewal EMEA/H/C/379/R/30 (2006)4401 of 29/09/2006
10/01/2007 Centralised - Notification EMEA/H/C/379/N/31
Updated with Decision(2008)7695 of 26/11/2008
07/11/2007 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/IA/32
06/08/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/IA/34
28/11/2008 Centralised - Variation EMEA/H/C/379/II/33 (2008)7695 of 26/11/2008
05/01/2009 Centralised - Variation EMEA/H/C/379/IA/36
Updated with Decision(2009)5409 of 01/07/2009
03/07/2009 Centralised - Variation EMEA/H/C/379/II/35, 37 (2009)5409 of 01/07/2009
28/07/2009 Centralised - Variation EMEA/H/C/379/II/38 (2009)5992 of 23/07/2009
02/12/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/IA/40
15/03/2010 Centralised - Variation EMEA/H/C/379/II/39 (2010)1656 of 11/03/2010
06/07/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/379/IA/41/G
18/11/2010 Centralised - Variation EMEA/H/C/379/IG/27/G
Updated with Decision(2011)295 of 17/01/2011
01/12/2010 Centralised - Variation EMEA/H/C/379/II/42 (2010)8554 of 26/11/2010
19/01/2011 Centralised - Variation (2011)295 of 17/01/2011
09/09/2011 Centralised - Renewal EMEA/H/C/379/R/43 (2011)6420 of 07/09/2011
19/01/2012 Centralised - Notification EMEA/H/C/379/N/44
Updated with Decision(2012)7926 of 29/10/2012
15/05/2012 Centralised - Variation EMEA/H/C/379/IB/47
Updated with Decision(2012)7926 of 29/10/2012
20/07/2012 Centralised - Variation EMEA/H/C/379/IB/48
Updated with Decision(2012)7926 of 29/10/2012
06/11/2012 Centralised - Variation (2012)7926 of 29/10/2012
25/04/2013 Centralised - Variation EMEA/H/C/379/II/51
Updated with Decision(2014)2815 of 23/04/2014
31/07/2013 Centralised - Notification EMEA/H/C/379/N/53
Updated with Decision(2014)2815 of 23/04/2014
25/04/2014 Centralised - Yearly update (2014)2815 of 23/04/2014
04/06/2014 Centralised - Variation EMEA/H/C/379/IB/55
16/09/2014 Centralised - Variation EMEA/H/C/379/IB/56