An overview of Kyprolis and why it is authorised in the EU
Kyprolis is a cancer medicine used together with the medicines lenalidomide and dexamethasone or with dexamethasone alone, to treat multiple myeloma (a cancer of the bone marrow). It is given to adults who have received at least one previous treatment for their cancer.
Kyprolis : EPAR - Medicine overview (PDF/78.64 KB)
First published: 01/12/2015
Last updated: 27/03/2018
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This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
Amgen Europe B.V.
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19/09/2018 Kyprolis - EMEA/H/C/003790 - II/0030
- 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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Kyprolis in combination with either lenalidomide and dexamethasone or dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.