Kepivance

Withdrawn

This medicine's authorisation has been withdrawn

palifermin

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Public Assessment Report (EPAR) for Kepivance is updated accordingly to indicate that the marketing authorisation is no longer valid.

Kepivance : EPAR - Summary for the public

Product information

Kepivance : EPAR - Product Information

Kepivance : EPAR - All Authorised presentations

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 products

Therapeutic 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.

Authorisation details

• EMA product number:
  EMEA/H/C/000609
• Marketing authorisation holder:
  Swedish Orphan Biovitrum AB (publ)

  SE-112 76 Stockholm; Sweden

• Marketing authorisation issued:
  25/10/2005
• Withdrawal of marketing authorisation:
  01/04/2016
• Revision:
  19

Assessment history

Changes since initial authorisation of medicine

Kepivance : EPAR - Procedural steps taken and scientific information after authorisation

CHMP post authorisation positive summary of opinion for Kepivance

Adopted

Initial marketing authorisation documents

Kepivance : EPAR - Procedural steps taken before authorisation

Kepivance : EPAR - Scientific Discussion