Basic Information
Evoltra
Regulatory Information
EMEA/H/C/000613
May 29, 2006
February 23, 2006
34
July 22, 2024
Company Information
Netherlands
Paasheuvelweg 25 1105 BP Amsterdam
Sanofi B.V.
Drug Classification
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### 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.
Overview Summary
This is a summary of the European public assessment report (EPAR) for Evoltra. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Evoltra.