Ivozall

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clofarabine

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

Overview

Ivozall is a cancer medicine that is used to treat children and adults up to 21 years of age who have acute lymphoblastic leukaemia (ALL), a cancer of the lymphocytes (a type of white blood cell). It is used when the disease has not responded to, or has come back (relapsed) after at least two other treatments and when no other treatment is expected to work. Ivozall contains the active substance clofarabine and is a ‘generic medicine’. This means that Ivozall contains the same active substance and works in the same way as a ‘reference medicine’ already authorised in the EU called Evoltra.

This EPAR was last updated on 22/11/2019

Authorisation details

Product details
Name
Ivozall
Agency product number
EMEA/H/C/005039
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
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.

GenericGeneric

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.

Publication details
Marketing-authorisation holder
ORPHELIA Pharma SAS
Date of issue of marketing authorisation valid throughout the European Union
14/11/2019
Contact address

85 Boulevard Saint-Michel
75005 Paris
France

Product information

14/11/2019 Ivozall - EMEA/H/C/005039 -

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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.

Assessment history

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