Kepivance

RSS

palifermin

Withdrawn
This medicine is now withdrawn from use in the European Union.

Overview

The marketing authorisation for Kepivance has been withdrawn at the request of the marketing authorisation holder.

This EPAR was last updated on 08/04/2016

Authorisation details

Product details
Name
Kepivance
Agency product number
EMEA/H/C/000609
Active substance
palifermin
International non-proprietary name (INN) or common name
palifermin
Therapeutic area (MeSH)
Mucositis
Anatomical therapeutic chemical (ATC) code
V03AF08
Publication details
Marketing-authorisation holder
Swedish Orphan Biovitrum AB (publ)
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
25/10/2005
Contact address
SE-112 76 Stockholm
Sweden

Product information

01/04/2016 Kepivance - EMEA/H/C/000609 - IB/0045

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

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.

Assessment history

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