Copiktra

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Withdrawn

This medicine's authorisation has been withdrawn

duvelisib
MedicineHumanWithdrawn

Romanian is available via eTranslation, the European Commission's machine translation service.

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  • Application under evaluation
  • CHMP opinion
  • European Commission decision

Overview

On 16 February 2026, the European Commission withdrew the marketing authorisation for Copiktra (duvelisib) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, Secura Bio Limited, which notified the European Commission of its decision not to market the product in the EU for commercial reasons.

Copiktra was granted marketing authorisation in the EU on 19 May 2021 for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukaemia (CLL) or refractory follicular lymphoma (FL). The marketing authorisation was initially valid for a 5-year period. The product has never been marketed in the EU.

Therapeutic alternatives are available throughout the EU. Patients taking Copiktra or participating in a clinical trial are advised to consult their doctor.

Copiktra : EPAR – Medicine overview

Reference Number: EMA/242496/2021

English (EN) (144.82 KB - PDF)

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български (BG) (151.41 KB - PDF)

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español (ES) (125.98 KB - PDF)

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čeština (CS) (146.52 KB - PDF)

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dansk (DA) (124.25 KB - PDF)

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Deutsch (DE) (128.06 KB - PDF)

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eesti (ET) (113.42 KB - PDF)

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ελληνικά (EL) (155.57 KB - PDF)

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français (FR) (127.19 KB - PDF)

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hrvatski (HR) (146 KB - PDF)

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italiano (IT) (123.46 KB - PDF)

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latviešu (LV) (157.07 KB - PDF)

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lietuvių (LT) (146.72 KB - PDF)

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magyar (HU) (146.93 KB - PDF)

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Malti (MT) (148.06 KB - PDF)

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Nederlands (NL) (123.13 KB - PDF)

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polski (PL) (151.64 KB - PDF)

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português (PT) (125.38 KB - PDF)

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română (RO) (145.31 KB - PDF)

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slovenčina (SK) (144.99 KB - PDF)

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slovenščina (SL) (143.84 KB - PDF)

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suomi (FI) (122.57 KB - PDF)

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svenska (SV) (123.26 KB - PDF)

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Copiktra : EPAR - Risk-management-plan summary

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Product information

Copiktra : EPAR - Product information

English (EN) (584.25 KB - PDF)

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български (BG) (667.29 KB - PDF)

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español (ES) (587.84 KB - PDF)

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čeština (CS) (634.66 KB - PDF)

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dansk (DA) (573.33 KB - PDF)

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Deutsch (DE) (606.09 KB - PDF)

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eesti (ET) (575.37 KB - PDF)

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ελληνικά (EL) (671.28 KB - PDF)

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français (FR) (607.44 KB - PDF)

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hrvatski (HR) (642.47 KB - PDF)

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italiano (IT) (577.37 KB - PDF)

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latviešu (LV) (647.24 KB - PDF)

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lietuvių (LT) (653.94 KB - PDF)

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magyar (HU) (663.3 KB - PDF)

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Malti (MT) (688.43 KB - PDF)

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Nederlands (NL) (600.83 KB - PDF)

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polski (PL) (673.23 KB - PDF)

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português (PT) (579.51 KB - PDF)

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română (RO) (687.71 KB - PDF)

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slovenčina (SK) (680.77 KB - PDF)

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slovenščina (SL) (667.81 KB - PDF)

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suomi (FI) (578.3 KB - PDF)

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svenska (SV) (576.76 KB - PDF)

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Íslenska (IS) (598.83 KB - PDF)

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norsk (NO) (589.05 KB - PDF)

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Latest procedure affecting product information:IB/0007/G
10/08/2023
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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).

Copiktra : EPAR - All authorised presentations

English (EN) (28.84 KB - PDF)

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български (BG) (69.96 KB - PDF)

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español (ES) (55.34 KB - PDF)

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čeština (CS) (54.61 KB - PDF)

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dansk (DA) (57.06 KB - PDF)

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Deutsch (DE) (56.52 KB - PDF)

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eesti (ET) (56.01 KB - PDF)

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ελληνικά (EL) (75.72 KB - PDF)

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français (FR) (55.53 KB - PDF)

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hrvatski (HR) (62.98 KB - PDF)

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italiano (IT) (54.58 KB - PDF)

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latviešu (LV) (80.61 KB - PDF)

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lietuvių (LT) (74.15 KB - PDF)

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magyar (HU) (74.07 KB - PDF)

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Malti (MT) (73.57 KB - PDF)

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Nederlands (NL) (55.16 KB - PDF)

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polski (PL) (74.8 KB - PDF)

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português (PT) (55.44 KB - PDF)

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română (RO) (62.31 KB - PDF)

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slovenčina (SK) (64.38 KB - PDF)

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slovenščina (SL) (63.62 KB - PDF)

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suomi (FI) (54.92 KB - PDF)

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svenska (SV) (55.75 KB - PDF)

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Íslenska (IS) (29.65 KB - PDF)

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norsk (NO) (29.15 KB - PDF)

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Product details

Name of medicine
Copiktra
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

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.

Authorisation details

EMA product number
EMEA/H/C/005381
Marketing authorisation holder
Secura Bio Limited

Secura Bio Limited
32 Molesworth Street
Dublin 2
Ireland

Opinion adopted
25/03/2021
Marketing authorisation issued
19/05/2021
Withdrawal of marketing authorisation
16/02/2026
Revision
3

Assessment history

Copiktra : EPAR - Procedural steps taken and scientific information after authorisation

English (EN) (132.32 KB - PDF)

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Copiktra : EPAR - Public assessment report

Adopted Reference Number: EMA/CHMP/236249/2021

English (EN) (10 MB - PDF)

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Copiktra : Orphan designation withdrawal assessment report (initial authorisation)

Adopted Reference Number: EMADOC-1700519818-645386

English (EN) (1.57 MB - PDF)

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CHMP summary of positive opinion for Copiktra

Adopted Reference Number: EMA/CHMP/84697/2021

English (EN) (184.92 KB - PDF)

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More information on Copiktra

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 26 April 2013. The product was withdrawn from the Union Register of orphan medicinal products by the European Commission in March 2021 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

This product is no longer an orphan medicine. It was originally designated an orphan medicine on 17 July 2013. The product was withdrawn from the Union Register of orphan medicinal products by the European Commission in March 2021 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.

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