Mevlyq (eribulin)
- Region
- 🇪🇺 EU
- Active substance
- eribulin
- Company
- YES Pharmaceutical Development Services GmbH
- Status
- Authorised
- Therapeutic area
- Breast Neoplasms; Liposarcoma
- CHMP opinion
- Thu 14 Dec 2023
- EU approval
- Fri 09 Feb 2024
- Designations
- Generic
- Application
- EMEA/H/C/006134
- ATC
- L01XX41
- Official record
- www.ema.europa.eu
Indication
Mevlyq is indicated for the treatment of adult patients with locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments. Mevlyq is indicated for the treatment of adult patients with unresectable liposarcoma who have received prior anthracycline containing therapy (unless unsuitable) for advanced or metastatic disease.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Eribulin Baxter Authorised · Baxter Holding B.V.
- 🇪🇺 Halaven Authorised · Eisai GmbH
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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.