Kepivance

Withdrawn

This medicine's authorisation has been withdrawn

palifermin

Overview

The marketing authorisation for Kepivance has been withdrawn at the request of the marketing authorisation holder.

Kepivance : EPAR - Summary for the public

Product information

Kepivance : EPAR - Product Information

Latest procedure affecting product information: IB/0045

01/04/2016

This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.

 

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).

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
• 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