Mycamine
micafungin
Table of contents
Overview
This is a summary of the European public assessment report (EPAR) for Mycamine. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Mycamine.
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Mycamine : EPAR - Summary for the public (PDF/80.76 KB)
First published: 14/07/2009
Last updated: 14/09/2011 -
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Mycamine : EPAR - Risk-management-plan summary (PDF/1.11 MB)
First published: 16/07/2019
Last updated: 31/03/2023
Authorisation details
Product details | |
---|---|
Name |
Mycamine
|
Agency product number |
EMEA/H/C/000734
|
Active substance |
micafungin
|
International non-proprietary name (INN) or common name |
micafungin
|
Therapeutic area (MeSH) |
Candidiasis
|
Anatomical therapeutic chemical (ATC) code |
J02AX05
|
Publication details | |
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Marketing-authorisation holder |
Astellas Pharma Europe B.V.
|
Revision |
18
|
Date of issue of marketing authorisation valid throughout the European Union |
25/04/2008
|
Contact address |
Elisabethhof 19
NL-2353 EW Leiderdorp The Netherlands |
Product information
09/02/2023 Mycamine - EMEA/H/C/000734 - II/0047
This medicine’s product information is available in all official EU languages.
Select ‘available languages’ to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antimycotics for systemic use
Therapeutic indication
Mycamine is indicated for:
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. Mycamine should therefore only be used if other antifungals are not appropriate.