Copiktra
duvelisib
Table of contents
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.
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Copiktra : EPAR – Medicine overview (PDF/140.04 KB)
First published: 31/05/2021
EMA/242496/2021 -
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Copiktra : EPAR - Risk-management-plan summary (PDF/119.9 KB)
First published: 31/05/2021
Authorisation details
Product details | |
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Name |
Copiktra
|
Agency product number |
EMEA/H/C/005381
|
Active substance |
duvelisib
|
International non-proprietary name (INN) or common name |
duvelisib
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01EM04
|
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. |
Publication details | |
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Marketing-authorisation holder |
Secura Bio Limited
|
Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
19/05/2021
|
Contact address |
Secura Bio Limited |
Product information
27/01/2022 Copiktra - EMEA/H/C/005381 - II/0002
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
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.