Pharmaceuticals - Community Register

  

Community list of not active medicinal products for human use


EXPIRED  

Product information

Invented name: Posaconazole SP
Auth. number : EU/1/05/321
INN : Posaconazole
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: J02AC04 - Posaconazole
(See WHO ATC Index)
Indication: indicated for use in the treatment of the following invasive fungal infections in adults:
- Invasive aspergillosis in patients with disease that is refractory to amphotericin B or itraconazole or in patients who are intolerant of these medicinal products;
- Fusariosis in patients with disease that is refractory to amphotericin B or in patients who are intolerant of amphotericin B;
- Chromoblastomycosis and mycetoma in patients with disease that is refractory to itraconazole or in patients who are intol
Marketing Authorisation Holder: SP Europe
Rue de Stalle, 73, 1180 Bruxelles, Belgique / Stallestraat, 73, 1180 Brussel/Bruxelles, Belgique/België

  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
27/10/2005 Centralised - Authorisation EMEA/H/C/611 (2005)4253 of 25/10/2005
02/11/2006 Centralised - Variation EMEA/H/C/611/II/1 (2006)5336 of 30/10/2006
03/01/2007 Centralised - Variation EMEA/H/C/611/N/3
Updated with Decision(2007)5382 of 30/10/2007
04/06/2007 Centralised - Variation EMEA/H/C/611/IB/5
12/09/2007 Centralised - Variation EMEA/H/C/611/IB/6
05/11/2007 Centralised - Variation EMEA/H/C/611/II/4 (2007)5382 of 30/10/2007
11/12/2007 Centralised - Variation EMEA/H/C/611/IA/8
08/02/2008 Centralised - Variation EMEA/H/C/611/IB/9
05/03/2008 Centralised - Variation EMEA/H/C/611/II/7 (2008)895 of 03/03/2008
15/09/2008 Centralised - Variation EMEA/H/C/611/IA/13
15/09/2008 Centralised - Variation EMEA/H/C/611/IA/13
17/09/2008 Centralised - Variation EMEA/H/C/611/IA/14
06/10/2008 Centralised - Variation EMEA/H/C/611/IA/15
20/11/2008 Centralised - Withdrawal