EMA — authorised 14 November 2019
- Marketing authorisation holder: ORPHELIA PHARMA SAS
- Status: approved
🇪🇺 Clolar in European Union
EMA authorised Clolar on 14 November 2019
Marketing authorisations
EMA — authorised 14 November 2019
- Application: EMEA/H/C/005039
- Marketing authorisation holder: ORPHELIA Pharma
- Local brand name: Ivozall
- 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.
- Status: withdrawn
Clolar in other countries
Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.
Other Oncology approved in European Union
Frequently asked questions
Is Clolar approved in European Union?
Yes. EMA authorised it on 14 November 2019; EMA authorised it on 14 November 2019.
Who is the marketing authorisation holder for Clolar in European Union?
ORPHELIA PHARMA SAS holds the EU marketing authorisation.