Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Ecalta   
Auth. number : EU/1/07/416
Active substance : anidulafungin
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: J02AX06 - Anidulafungin
(See WHO ATC Index)
Indication: Treatment of invasive candidiasis in adult patients.
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
24/09/2007 Centralised - Authorisation EMEA/H/C/788 (2007)4439 of 20/09/2007
11/06/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/788/II/2
03/07/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/788/IA/3
28/10/2008 Centralised - Variation (no change in Commission Decision) EMEA/H/C/788/II/4
08/01/2009 Centralised - Variation EMEA/H/C/788/II/6 (2009)29 of 06/01/2009
26/01/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/788/II/5
25/02/2009 Centralised - Notification EMEA/H/C/788/N/8
Updated with Decision(2009)5986 of 23/07/2009
28/04/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/788/IB/9
18/05/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/788/IB/11
21/07/2009 Centralised - Variation EMEA/H/C/788/II/10 (2009)5831 of 16/07/2009
28/07/2009 Centralised - Variation EMEA/H/C/788/X/7 (2009)5986 of 23/07/2009
24/09/2009 Centralised - Variation (no change in Commission Decision) EMEA/H/C/788/IA/12
06/09/2010 Centralised - Variation EMEA/H/C/788/II/13 (2010)6132 of 01/09/2010
26/10/2010 Centralised - Variation EMEA/H/C/788/IB/14
Updated with Decision(2011)4801 of 29/06/2011
01/12/2010 Centralised - Variation (no change in Commission Decision) EMEA/H/C/788/IB/15
22/03/2011 Centralised - Variation EMEA/H/C/788/IB/16
Updated with Decision(2011)4801 of 29/06/2011
24/03/2011 Centralised - Variation EMEA/H/C/788/IG/44/G
Updated with Decision(2011)4801 of 29/06/2011
01/07/2011 Centralised - Variation (2011)4801 of 29/06/2011
29/07/2011 Centralised - Variation EMEA/H/C/788/II/17 (2011)5575 of 27/07/2011
09/12/2011 Referral EMEA/H/C/788/A-20/19 (2011)9290 of 07/12/2011
31/05/2012 Referral EMEA/H/C/788/A-20 (2012)3589 of 25/05/2012
03/07/2012 Centralised - Variation EMEA/H/C/788/II/21 (2012)4601 of 28/06/2012
28/08/2012 Centralised - Renewal EMEA/H/C/788/R/20 (2012)6013 of 23/08/2012
08/08/2013 Centralised - Notification EMEA/H/C/788/N/25
Updated with Decision(2014)6190 of 26/08/2014
28/08/2014 Centralised - 2-Monthly update EMEA/H/C/788/II/26 (2014)6190 of 26/08/2014
05/09/2014 Centralised - Notification EMEA/H/C/788/N/28
24/06/2015 Centralised - Notification EMEA/H/C/788/N/29