EMA — authorised 24 March 2020
- Marketing authorisation holder: Novartis Europharm Limited
- Status: approved
🇪🇺 Scemblix in European Union
EMA authorised Scemblix on 24 March 2020
Marketing authorisations
EMA — authorised 25 August 2022
- Application: EMEA/H/C/005605
- Marketing authorisation holder: Novartis Europharm Limited
- Local brand name: Scemblix
- Indication: Scemblix is indicated for the treatment of adult patients with Philadelphia chromosome positive chronic myeloid leukaemia in chronic phase (Ph+ CML CP). Scemblix is indicated for the treatment of adult patients with Ph+ CML-CP with the T315I mutation who are resistant to, intolerant to or ineligible for ponatinib (see section 5.1).
- Pathway: orphan
- Status: approved
Scemblix 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 Scemblix approved in European Union?
Yes. EMA authorised it on 24 March 2020; EMA authorised it on 25 August 2022.
Who is the marketing authorisation holder for Scemblix in European Union?
Novartis Europharm Limited holds the EU marketing authorisation.