Pharmaceuticals - Community Register

  

Community register of medicinal products for human use


AUTHORISED  

Product information

Invented name: Mycamine   
Auth. number : EU/1/08/448
INN : micafungin
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: J02AX05 - Micafungin
(See WHO ATC Index)
Indication: Adults, adolescents ≥ 16 years of age and elderly:
- Treatment of invasive candidiasis.
- Treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate.
- Prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells / μl) for 10 or more days.
Children (including neonates) and adolescents < 16 years of age:
- Treatment of invasive candidiasis.
- Prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation or patients who are expected to have neutropenia (absolute neutrophil count < 500 cells / μl) for 10 or more days.
The decision to use Mycamine should take into account a potential risk for the development of liver tumours (see section 4.4). Mycamine should therefore only be used if other antifungals are not appropriate.
Marketing Authorisation Holder: Astellas Pharma Europe B.V.
Sylviusweg 62, NL-2333 BE Leiden, Nederland

  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
29/04/2008 Centralised - Authorisation EMEA/H/C/734 (2008)1727 of 25/04/2008
29/04/2008 Centralised - Authorisation - Decision addressed to Member States EMEA/H/C/734 (2008)1728 of 25/04/2008
01/10/2008 Centralised - Transfer Marketing Authorisation Holder EMEA/H/C/734/T/1 (2008)5644 of 29/09/2008
16/04/2009 Centralised - Variation EMEA/H/C/734/IB/3
24/04/2009 Corrigendum
20/08/2009 Centralised - Variation EMEA/H/C/734/II/2
24/11/2009 Centralised - Variation EMEA/H/C/734/II/4 (2009)9334 of 20/11/2009
10/08/2010 Centralised - Variation EMEA/H/C/734/II/5 (2010)5599 of 06/08/2010
19/08/2010 Centralised - Variation EMEA/H/C/734/IA/7/G
Updated with Decision(2010)7689 of 29/10/2010
05/11/2010 Centralised - Variation (2010)7689 of 29/10/2010
23/12/2010 Centralised - Variation EMEA/H/C/734/II/6 (2010)9647 of 20/12/2010
10/03/2011 Centralised - Variation EMEA/H/C/734/IA/9
26/08/2011 Centralised - Variation EMEA/H/C/734/II/10 (2011)6123 of 24/08/2011
26/08/2011 Centralised - Variation EMEA/H/C/734/II/10 (2011)6122 of 24/08/2011
07/01/2013 Centralised - Renewal EMEA/H/C/734/R/15 (2012)9941 of 20/12/2012
21/01/2013 Centralised - Variation EMEA/H/C/734/IAin/17
Updated with Decision(2014)1256 of 20/02/2014
18/12/2013 Centralised - Variation EMEA/H/C/734/II/21
Updated with Decision(2014)1256 of 20/02/2014
24/02/2014 Centralised - Variation (2014)1256 of 20/02/2014