Evoltra (clofarabine)
Exceptional circumstancesAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- clofarabine
- Company
- Sanofi B.V.
- Status
- Authorised
- Therapeutic area
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- CHMP opinion
- Thu 23 Feb 2006
- EU approval
- Mon 29 May 2006
- Designations
- Exceptional circumstances, Additional monitoring
- Application
- EMEA/H/C/000613
- ATC
- L01BB06
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Ivozall Withdrawn · ORPHELIA Pharma
Follow Evoltra
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.