Mepact

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mifamurtide

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

Overview

This is a summary of the European public assessment report (EPAR) for Mepact. 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 Mepact.

This EPAR was last updated on 10/04/2019

Authorisation details

Product details
Name
Mepact
Agency product number
EMEA/H/C/000802
Active substance
mifamurtide
International non-proprietary name (INN) or common name
mifamurtide
Therapeutic area (MeSH)
Osteosarcoma
Anatomical therapeutic chemical (ATC) code
L03AX15
Publication details
Marketing-authorisation holder
Takeda France SAS
Revision
14
Date of issue of marketing authorisation valid throughout the European Union
06/03/2009
Contact address
Immeuble Pacific
11-13 cours Valmy
92800 Puteaux
France

Product information

20/02/2019 Mepact - EMEA/H/C/000802 - R/0047

Contents

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

Pharmacotherapeutic group

Immunostimulants

Therapeutic indication

Mepact is indicated in children, adolescents and young adults for the treatment of high-grade resectable non-metastatic osteosarcoma after macroscopically complete surgical resection. It is used in combination with postoperative multi-agent chemotherapy. Safety and efficacy have been assessed in studies of patients two to 30 years of age at initial diagnosis.

Assessment history

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