Kepivance

palifermin

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The marketing authorisation for Kepivance has been withdrawn at the request of the marketing authorisation holder.

Name Language First published Last updated
Kepivance : EPAR - Summary for the public BG = bălgarski 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public ES = español 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public CS = čeština 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public DA = dansk 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public DE = Deutsch 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public ET = eesti keel 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public EL = elliniká 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public EN = English 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public FR = français 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public IT = italiano 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public LV = latviešu valoda 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public LT = lietuvių kalba 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public HU = magyar 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public MT = Malti 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public NL = Nederlands 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public PL = polski 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public PT = português 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public RO = română 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public SK = slovenčina 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public SL = slovenščina 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public FI = suomi 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public SV = svenska 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public HR = Hrvatski 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public IS = Islenska 10/08/2009 08/04/2016
Kepivance : EPAR - Summary for the public NO = Norsk 10/08/2009 08/04/2016

This EPAR was last updated on 08/04/2016 .

Authorisation details

Product details

Product details for Kepivance
NameKepivance
Agency product numberEMEA/H/C/000609
Active substance

palifermin

International non-proprietary name (INN) or common name

palifermin

Therapeutic area Mucositis
Anatomical therapeutic chemical (ATC) code V03AF08

Publication details

Publication details for Kepivance
Marketing-authorisation holder

Swedish Orphan Biovitrum AB (publ)

Revision19
Date of issue of marketing authorisation valid throughout the European Union25/10/2005

Contact address:

Swedish Orphan Biovitrum AB (publ)
SE-112 76 Stockholm
Sweden

Product information

Product information

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

Name Language First published Last updated
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016
Kepivance : EPAR - Product Information NO = Norsk 08/09/2009 08/04/2016

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.


Name Language First published Last updated
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - All Authorised presentations NO = Norsk 08/08/2006 08/04/2016

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

Changes since initial authorisation of medicine

Name Language First published Last updated
Kepivance : EPAR - Procedural steps taken and scientific information after authorisation NO = Norsk 08/09/2009 08/04/2016
CHMP post authorisation positive summary of opinion for Kepivance NO = Norsk 19/03/2010 08/04/2016

Initial marketing-authorisation documents

Name Language First published Last updated
Kepivance : EPAR - Procedural steps taken before authorisation NO = Norsk 08/08/2006 08/04/2016
Kepivance : EPAR - Scientific Discussion NO = Norsk 08/08/2006 08/04/2016

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Kepivance