| EMA number | EMEA/H/C/005039 |
| ATC code | L01BB06 |
| Authorisation | 14 November 2019 |
| Withdrawn | 18 October 2023 |
| Revision | 5 |
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.