Kepivance
Withdrawn
This medicine's authorisation has been withdrawn
palifermin
MedicineHumanWithdrawn
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- Application under evaluation
- CHMP opinion
- European Commission decision
Overview
On 1 April 2016, the European Commission withdrew the marketing authorisation for Kepivance (palifermin) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Swedish Orphan Biovitrum AB (publ), which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons.
Kepivance was granted marketing authorisation in the EU on 25 October 2005 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. The marketing authorisation holder has committed to ensure that patients who need treatment with Kepivance continue to receive it until complete exhaustion of stock.
The European Public Assessment Report (EPAR) for Kepivance is updated accordingly to indicate that the marketing authorisation is no longer valid.
Product information
Latest procedure affecting product information:IB/0045
01/04/2016
This medicine’s product information is available in all official EU languages.
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Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Kepivance
- Active substance
- palifermin
- International non-proprietary name (INN) or common name
- palifermin
- Therapeutic area (MeSH)
- Mucositis
- Anatomical therapeutic chemical (ATC) code
- V03AF08
Pharmacotherapeutic group
All other therapeutic productsTherapeutic 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.
Assessment history
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