Mepact
mifamurtide
Table of contents
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.
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 |
18
|
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
12/07/2023 Mepact - EMEA/H/C/000802 - IB/0058
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
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.