Kepivance (palifermin)
- Region
- 🇪🇺 EU
- Active substance
- palifermin
- Company
- Swedish Orphan Biovitrum AB (publ)
- Status
- Withdrawn
- Therapeutic area
- Mucositis
- EU approval
- Tue 25 Oct 2005
- Application
- EMEA/H/C/000609
- ATC
- V03AF08
- Official record
- www.ema.europa.eu
Indication
Kepivance is indicated to decrease the incidence, duration and severity of oral mucositis in adult patients with haematological malignancies receiving myeloablative radiochemotherapy associated with a high incidence of severe mucositis and requiring autologous-haematopoietic-stem-cell support.
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.