Kepivance

RSS
Withdrawn

This medicine's authorisation has been withdrawn

palifermin
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

The marketing authorisation for Kepivance has been withdrawn at the request of the marketing authorisation holder.

Kepivance : EPAR - Summary for the public

English (EN) (551.58 KB - PDF)

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български (BG) (1.29 MB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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español (ES) (697 KB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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čeština (CS) (1.07 MB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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dansk (DA) (723.35 KB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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Deutsch (DE) (761.45 KB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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eesti keel (ET) (712.02 KB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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ελληνικά (EL) (1.29 MB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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français (FR) (734.27 KB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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hrvatski (HR) (790.19 KB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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íslenska (IS) (725.16 KB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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italiano (IT) (730.29 KB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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latviešu valoda (LV) (1.08 MB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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lietuvių kalba (LT) (817.91 KB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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magyar (HU) (1.08 MB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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Malti (MT) (1.1 MB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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Nederlands (NL) (727.76 KB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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norsk (NO) (687.78 KB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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polski (PL) (1.11 MB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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português (PT) (695.67 KB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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română (RO) (841.19 KB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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slovenčina (SK) (1.07 MB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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slovenščina (SL) (1.06 MB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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Suomi (FI) (701.32 KB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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svenska (SV) (705.6 KB - PDF)

First published: 10/08/2009Last updated: 08/04/2016
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Product information

Kepivance : EPAR - Product Information

English (EN) (696.57 KB - PDF)

First published: Last updated:
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български (BG) (1.29 MB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

español (ES) (697 KB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

čeština (CS) (1.07 MB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

dansk (DA) (723.35 KB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

Deutsch (DE) (761.45 KB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

eesti keel (ET) (712.02 KB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

ελληνικά (EL) (1.29 MB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

français (FR) (734.27 KB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

hrvatski (HR) (790.19 KB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

íslenska (IS) (725.16 KB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

italiano (IT) (730.29 KB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

latviešu valoda (LV) (1.08 MB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

lietuvių kalba (LT) (817.91 KB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

magyar (HU) (1.08 MB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

Malti (MT) (1.1 MB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

Nederlands (NL) (727.76 KB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

norsk (NO) (687.78 KB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

polski (PL) (1.11 MB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

português (PT) (695.67 KB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
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română (RO) (841.19 KB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
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slovenčina (SK) (1.07 MB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
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slovenščina (SL) (1.06 MB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
View

Suomi (FI) (701.32 KB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
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svenska (SV) (705.6 KB - PDF)

First published: 08/09/2009Last updated: 08/04/2016
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Latest procedure affecting product information: IB/0045
01/04/2016
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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

English (EN) (461.15 KB - PDF)

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български (BG) (545.61 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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español (ES) (461.28 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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čeština (CS) (476.37 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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dansk (DA) (461.06 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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Deutsch (DE) (461.9 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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eesti keel (ET) (461.3 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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ελληνικά (EL) (496.12 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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français (FR) (461.21 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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italiano (IT) (461.19 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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latviešu valoda (LV) (477.53 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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lietuvių kalba (LT) (464.69 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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magyar (HU) (474.42 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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Malti (MT) (529.83 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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Nederlands (NL) (461.25 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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polski (PL) (476.72 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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português (PT) (461.3 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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română (RO) (518.88 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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slovenčina (SK) (476.53 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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slovenščina (SL) (474.28 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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Suomi (FI) (461.35 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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svenska (SV) (461.5 KB - PDF)

First published: 08/08/2006Last updated: 08/04/2016
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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

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

English (EN) (672.64 KB - PDF)

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CHMP post authorisation positive summary of opinion for Kepivance

Adopted

English (EN) (501.89 KB - PDF)

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Kepivance : EPAR - Procedural steps taken before authorisation

English (EN) (476.94 KB - PDF)

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Kepivance : EPAR - Scientific Discussion

English (EN) (1.52 MB - PDF)

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More information on Kepivance

Public statement on Kepivance: Withdrawal of the marketing authorisation in the European Union

Reference Number: EMA/250017/2016

English (EN) (65.68 KB - PDF)

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