The marketing authorisation for Kepivance has been withdrawn at the request of the marketing authorisation holder.
Kepivance : EPAR - Summary for the public (PDF/551.58 KB)
First published: 10/08/2009
Last updated: 08/04/2016
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Swedish Orphan Biovitrum AB (publ)
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01/04/2016 Kepivance - EMEA/H/C/000609 - IB/0045
- 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
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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.