Kyprolis
carfilzomib
Table of contents
Overview
Kyprolis is a cancer medicine used together with the medicines daratumumab and dexamethasone, or 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 contains the active substance carfilzomib.
Multiple myeloma is rare, and Kyprolis was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 3 June 2008.
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List item
Kyprolis : EPAR - Medicine overview (PDF/130.53 KB)
First published: 01/12/2015
Last updated: 28/01/2021
EMA/629102/2020 -
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List item
Kyprolis : EPAR - Risk-management-plan summary (PDF/89.77 KB)
First published: 05/06/2019
Authorisation details
Product details | |
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Name |
Kyprolis
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Agency product number |
EMEA/H/C/003790
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Active substance |
carfilzomib
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International non-proprietary name (INN) or common name |
carfilzomib
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Therapeutic area (MeSH) |
Multiple Myeloma
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Anatomical therapeutic chemical (ATC) code |
L01XX45
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Accelerated assessment |
This medicine had an accelerated assessment. This means that it is a medicine of major interest for public health, so its timeframe for review was 150 evaluation days rather than 210. For more information, see Accelerated assessment. |
Orphan |
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. |
Publication details | |
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Marketing-authorisation holder |
Amgen Europe B.V.
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Revision |
20
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Date of issue of marketing authorisation valid throughout the European Union |
19/11/2015
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Contact address |
Minervum 7061
Breda 4817ZK The Netherlands |
Product information
01/04/2022 Kyprolis - EMEA/H/C/003790 - II/0051/G
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
Antineoplastic agents
Therapeutic indication
Kyprolis in combination with daratumumab and dexamethasone, with lenalidomide and dexamethasone, or with dexamethasone alone is indicated for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
Assessment history
News
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Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 9-12 November 202013/11/2020
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27/05/2016
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25/09/2015
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25/09/2015