Mepact (mifamurtide)
- Region
- 🇪🇺 EU
- Active substance
- mifamurtide
- Company
- Esteve Pharmaceuticals, S.A.
- Status
- Authorised
- Therapeutic area
- Osteosarcoma
- EU approval
- Fri 06 Mar 2009
- Application
- EMEA/H/C/000802
- ATC
- L03AX15
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.