Ivozall

Withdrawn

This medicine's authorisation has been withdrawn

clofarabine

Overview

On 18 October 2023, the European Commission withdrew the marketing authorisation for Ivozall (clofarabine) in the European Union (EU). The withdrawal was at the request of the marketing authorisation holder, ORPHELIA Pharma SAS, which notified the European Commission of its decision to permanently discontinue the marketing of the product for commercial reasons. 

Ivozall was granted marketing authorisation in the EU on 14 November 2019 for treatment of acute lymphoblastic leukaemia. The marketing authorisation was initially valid for a 5-year period. The product had not been marketed in the EU since 2022. 

Ivozall is a generic medicine of Evoltra. There are other generic medicinal products of Evoltra authorised and marketed in the EU. 

The European Public Assessment Report (EPAR) for Ivozall is updated to indicate that the marketing authorisation is no longer valid.

Ivozall : EPAR - Medicine overview

Reference Number: EMA/519636/2019

Ivozall : EPAR - Risk-management-plan summary

Product information

Ivozall : EPAR - Product Information

Ivozall : EPAR - All authorised presentations

Product details

• Name of medicine:
  Ivozall
• Active substance:
  clofarabine
• International non-proprietary name (INN) or common name:
  clofarabine
• Therapeutic area (MeSH):
  Precursor Cell Lymphoblastic Leukemia-Lymphoma
• Anatomical therapeutic chemical (ATC) code:
  L01BB06

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients who have relapsed or are refractory after receiving at least two prior regimens and where there is no other treatment option anticipated to result in a durable response. Safety and efficacy have been assessed in studies of patients ? 21 years old at initial diagnosis.

Authorisation details

• EMA product number:
  EMEA/H/C/005039
• Generic:

  This is a generic medicine, which is developed to be the same as a medicine that has already been authorised, called the reference medicine. A generic medicine contains the same active substance(s) as the reference medicine, and is used at the same dose(s) to treat the same disease(s). For more information, see Generic and hybrid medicines.

• Marketing authorisation holder:
  ORPHELIA Pharma

  85 Boulevard Saint-Michel; 75005 Paris; France

• Opinion adopted:
  19/09/2019
• Marketing authorisation issued:
  14/11/2019
• Withdrawal of marketing authorisation:
  18/10/2023
• Revision:
  5

Assessment history

Changes since initial authorisation of medicine

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

Ivozall-H-C-PSUSA-00000805-201912 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

AdoptedReference Number: EMA/517911/2020

Initial marketing authorisation documents

Ivozall : EPAR - Public assessment report

AdoptedReference Number: EMA/CHMP/585665/2019

CHMP summary of positive opinion for Ivozall

AdoptedReference Number: EMA/CHMP/494372/2019