Ivozall

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Withdrawn

This medicine's authorisation has been withdrawn

clofarabine
MedicineHumanWithdrawn
  • Application under evaluation
  • CHMP opinion
  • European Commission decision

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The European Public Assessment Report (EPAR) for Ivozall is updated to indicate that the marketing authorisation is no longer valid.

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Product information

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Latest procedure affecting product information: IB/0006
06/03/2023
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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).

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Suomi (FI) (41.19 KB - PDF)

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svenska (SV) (42.52 KB - PDF)

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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

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