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.
Mepact : EPAR - Summary for the public (PDF/79.64 KB)
First published: 06/05/2009
Last updated: 01/10/2013
|Agency product number||
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
|Anatomical therapeutic chemical (ATC) code||
Takeda France SAS
|Date of issue of marketing authorisation valid throughout the European Union||
16/12/2019 Mepact - EMEA/H/C/000802 - PSUSA/00002059/201903
- 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.
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.
Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 13-16 February 201217/02/2012
European Medicines Agency gives final recommendations for 12 centrally authorised medicines manufactured at Ben Venue Laboratories16/02/2012
European Medicines Agency recommends precautionary recall of remaining batch of Vistide manufactured at Ben Venue Laboratories13/12/2011
European Medicines Agency gives further interim recommendations on dealing with shortcomings in quality assurance at Ben Venue Laboratories09/12/2011
European Medicines Agency gives interim recommendations to deal with shortcomings in quality assurance at Ben Venue Laboratories22/11/2011