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Community Register of medicinal products
Community register of medicinal products for human use |
AUTHORISED |
Product information |
| Invented name: | Mycamine
|
| Auth. number : | EU/1/08/448 |
| INN : | micafungin |
| ATC: | J - General antiinfectives for systemic use J02 - Antimycotics for systemic use J02A - Antimycotics for systemic use J02AX - Other antimycotics for systemic use 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. |
| Marketing Authorisation Holder: | Astellas Pharma Europe B.V.
Sylviusweg 62, NL-2333 BE Leiden, Nederland |
EPAR and active package presentations
Package presentations
|
The section of the Community Register "Package presentations" will no longer be updated as from 2 November 2012.
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 procedures
| Close date procedure | Procedure type | EMEA number | Decision | summary publ | decision docs | annex |
| 29/04/2008 | Centralised - Authorisation - Decision addressed to Member States | EMEA/H/C/734 | (2008)1728 of 25/04/2008 | |||
| 29/04/2008 | Centralised - Authorisation | EMEA/H/C/734 | (2008)1727 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 | - | (2012)9941 of 20/12/2012 | |||
| 21/01/2013 | Centralised - Variation | EMEA/H/C/734/IAin/17 | ||||