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The marketing authorisation for Kepivance has been withdrawn at the request of the marketing authorisation holder.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 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public ES = español 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public CS = čeština 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public DA = dansk 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public DE = Deutsch 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public ET = eesti keel 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public EL = elliniká 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public EN = English 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public FR = français 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public IT = italiano 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public LV = latviešu valoda 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public LT = lietuvių kalba 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public HU = magyar 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public MT = Malti 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public NL = Nederlands 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public PL = polski 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public PT = português 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public RO = română 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public SK = slovenčina 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public SL = slovenščina 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public FI = suomi 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public SV = svenska 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public HR = Hrvatski 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public IS = Islenska 2009-08-10 2016-04-08
Kepivance : EPAR - Summary for the public NO = Norsk 2009-08-10 2016-04-08

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 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08
Kepivance : EPAR - Product Information NO = Norsk 2009-09-08 2016-04-08

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 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08
Kepivance : EPAR - All Authorised presentations NO = Norsk 2006-08-08 2016-04-08

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 2009-09-08 2016-04-08
CHMP post authorisation positive summary of opinion for Kepivance NO = Norsk 2010-03-19 2016-04-08

Initial marketing-authorisation documents

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

Withdrawn

This medicine is now withdrawn from use in the European Union

More information on Kepivance