Data from EMA (European Medicines Agency) - Curated by EPG Health - Last updated 13 March 2018

Indication(s)

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.

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More information

Category Value
Agency product number EMEA/H/C/000613
Orphan designation No
Date First Approved 29-05-2006
Type Medicinal product subject to restricted medical prescription
Marketing authorisation holder Genzyme Europe B.V.
Warnings

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reacti