Kyprolis

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carfilzomib

Authorised
This medicine is authorised for use in the European Union.

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.

This EPAR was last updated on 07/05/2021

Authorisation details

Product details
Name
Kyprolis
Agency product number
EMEA/H/C/003790
Active substance
carfilzomib
International non-proprietary name (INN) or common name
carfilzomib
Therapeutic area (MeSH)
Multiple Myeloma
Anatomical therapeutic chemical (ATC) code
L01XX45
Accelerated assessmentAccelerated 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.

OrphanOrphan

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
Marketing-authorisation holder
Amgen Europe B.V.
Revision
19
Date of issue of marketing authorisation valid throughout the European Union
19/11/2015
Contact address
Minervum 7061
Breda 4817ZK
The Netherlands

Product information

16/04/2021 Kyprolis - EMEA/H/C/003790 - PSUSA/00010448/202007

Contents

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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

Changes since initial authorisation of medicine

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