EMA — authorised 6 March 2009
- Marketing authorisation holder: Takeda France SAS
- Status: approved
🇪🇺 Mepact in European Union
EMA authorised Mepact on 6 March 2009
Marketing authorisations
EMA — authorised 6 March 2009
- Application: EMEA/H/C/000802
- Marketing authorisation holder: Esteve Pharmaceuticals, S.A.
- Local brand name: Mepact
- 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.
- Status: approved
Mepact in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Mepact approved in European Union?
Yes. EMA authorised it on 6 March 2009; EMA authorised it on 6 March 2009.
Who is the marketing authorisation holder for Mepact in European Union?
Takeda France SAS holds the EU marketing authorisation.