Yaxwer (denosumab)
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- denosumab
- Company
- Gedeon Richter Plc.
- Status
- Authorised
- Therapeutic area
- Neoplasms, Bone Tissue; Giant Cell Tumor of Bone
- CHMP opinion
- Fri 25 Apr 2025
- EU approval
- Mon 23 Jun 2025
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006437
- ATC
- M05BX04
- Official record
- www.ema.europa.eu
Indication
Prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.Treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
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.