Mycamine

RSS

micafungin

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 01/03/2018

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
Marketing-authorisation holder
Astellas Pharma Europe B.V.
Revision
12
Date of issue of marketing authorisation valid throughout the European Union
24/04/2008
Contact address
Elisabethhof 19
NL-2353 EW Leiderdorp
The Netherlands

Product information

19/02/2018 Mycamine - EMEA/H/C/000734 - R/0034

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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