Kyprolis

RSS

carfilzomib

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

Overview

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 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 18/10/2018

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
Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

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
Marketing-authorisation holder
Amgen Europe B.V.
Revision
13
Date of issue of marketing authorisation valid throughout the European Union
18/11/2015
Contact address
Minervum 7061
Breda 4817ZK
The Netherlands

Product information

19/09/2018 Kyprolis - EMEA/H/C/003790 - II/0030

Contents

  • 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

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

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.

Assessment history

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