Copiktra

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duvelisib

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

Overview

Copiktra is a cancer medicine used to treat chronic lymphocytic leukaemia (CLL, a cancer of a type of white blood cells called B lymphocytes) and follicular lymphoma (another cancer that affects B lymphocytes).

In CLL, Copiktra is used in patients whose disease has either come back or not improved after at least two other treatments. In follicular lymphoma, it is used in patients whose disease has not improved after at least two other treatments. 

Copiktra contains the active substance duvelisib.

This EPAR was last updated on 10/11/2021

Authorisation details

Product details
Name
Copiktra
Agency product number
EMEA/H/C/005381
Active substance
duvelisib
International non-proprietary name (INN) or common name
duvelisib
Therapeutic area (MeSH)
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Lymphoma, Follicular
Anatomical therapeutic chemical (ATC) code
L01EM04
Additional monitoringAdditional 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.

Publication details
Marketing-authorisation holder
Secura Bio Limited
Revision
1
Date of issue of marketing authorisation valid throughout the European Union
19/05/2021
Contact address

Secura Bio Limited
32 Molesworth Street
Dublin 2
Ireland

Product information

20/08/2021 Copiktra - EMEA/H/C/005381 - T/0001

Product information documents contain:

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

Copiktra monotherapy is indicated for the treatment of adult patients with: 

  • Relapsed or refractory chronic lymphocytic leukaemia (CLL) after at least two prior therapies. 
  • Follicular lymphoma (FL) that is refractory to at least two prior  systemic therapies.

Assessment history

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