Evoltra

clofarabine · Sanofi B.V.
EXCEPTIONAL CIRCUMSTANCES AUTHORISED IN THE EU

What Evoltra is used for

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 … (the exact criteria are in the official EMA product information).

Approved use, as published by the European Medicines Agency.

What the labels mean

  • Approved under exceptional circumstances: full data cannot be collected, usually because the disease is very rare.

Key facts

Brand
Evoltra
Active substance
clofarabine
Disease area
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Medicine group
Antineoplastic agents
ATC code
L01BB06
Marketing authorisation holder
Sanofi B.V.
Authorised in the EU since
2006

Official information

In India

Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.

Common questions

What is Evoltra used for?

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 … (the exact criteria are in the official EMA product information).

What is the active substance in Evoltra?

Evoltra contains clofarabine.

Who makes Evoltra?

The EU marketing authorisation holder is Sanofi B.V..

Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.

← All specialty medicines, EU

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