Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Noxafil   
Auth. number : EU/1/05/320
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: Noxafil oral suspension is indicated for use in the treatment of the following 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 intolerant of itraconazole;
-  Coccidioidomycosis in patients with disease that is refractory to amphotericin B, itraconazole or fluconazole or in patients who are intolerant of these medicinal products;
- Oropharyngeal candidiasis: as first-line therapy in patients who have severe disease or are immunocompromised, in whom response to topical therapy is expected to be poor.

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.

Noxafil oral suspension is also indicated for prophylaxis of invasive fungal infections in the following patients:

- Patients receiving remission-induction chemotherapy for acute myelogenous leukemia (AML) or myelodysplastic syndromes (MDS) expected to result in prolonged neutropenia and who are at high risk of developing invasive fungal infections;
- Hematopoietic stem cell transplant (HSCT) recipients who are undergoing high-dose immunosuppressive therapy for graft versus host disease and who are at high risk of developing invasive fungal infections.
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 continues to be 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/610 (2005)4251 of 25/10/2005
02/11/2006 Centralised - Variation EMEA/H/C/610/II/1 (2006)5335 of 30/10/2006
03/01/2007 Centralised - Variation EMEA/H/C/610/N/3
Updated with Decision(2007)5381 of 30/10/2007
04/06/2007 Centralised - Variation EMEA/H/C/610/IB/5
12/09/2007 Centralised - Variation EMEA/H/C/610/IB/6
05/11/2007 Centralised - Variation EMEA/H/C/610/II/4 (2007)5381 of 30/10/2007
11/12/2007 Centralised - Variation EMEA/H/C/610/IA/8
08/02/2008 Centralised - Variation EMEA/H/C/610/IB/9
05/03/2008 Centralised - Variation EMEA/H/C/610/II/7 (2008)894 of 03/03/2008
15/09/2008 Centralised - Variation EMEA/H/C/610/IA/13
17/09/2008 Centralised - Variation EMEA/H/C/610/IA/14
06/10/2008 Centralised - Variation EMEA/H/C/610/IA/15
09/12/2008 Centralised - Variation EMEA/H/C/610/II/11 (2008)8163 of 04/12/2008
26/01/2009 Centralised - Variation EMEA/H/C/610/II/16
30/10/2009 Centralised - Variation EMEA/H/C/610/II/12 (2009)8502 of 28/10/2009
25/11/2009 Centralised - Variation EMEA/H/C/610/II/17 (2009)9444 of 23/11/2009
07/06/2010 Centralised - Variation EMEA/H/C/610/IB/19
Updated with Decision(2010)6903 of 30/09/2010
05/10/2010 Centralised - Renewal EMEA/H/C/610/R/18 (2010)6903 of 30/09/2010
04/02/2011 Centralised - Variation EMEA/H/C/610/N/20
Updated with Decision(2011)7249 of 06/10/2011
27/06/2011 Centralised - Variation EMEA/H/C/610/N/21
Updated with Decision(2011)7249 of 06/10/2011
10/10/2011 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/610/T/22, (2011)7249 of 06/10/2011
21/12/2011 Centralised - Variation EMEA/H/C/610/II/23 (2011)9948 of 19/12/2011
28/08/2012 Centralised - Variation EMEA/H/C/610/II/25 (2012)6025 of 23/08/2012
14/06/2013 Corrigendum
01/07/2013 Centralised - Variation EMEA/H/C/610/N/31
19/09/2013 Centralised - Variation EMEA/H/C/610/II/32