Human medicines European public assessment report (EPAR): Mevlyq, eribulin, Status: Opinion
Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates.
- Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates.
- Since Mevlyq is administered intravenously and is 100% bioavailable, a bioequivalence study versus the reference product Halaven was not required.
- Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.
- - Marketing authorisation applicant
- YES Pharmaceutical Development Services GmbH
- Opinion adopted
- 14/12/2023
- Opinion status
- Positive