EMA — authorised 19 September 2019
- Marketing authorisation holder: Bayer AG
- Status: approved
🇪🇺 Vitrakvi in European Union
EMA authorised Vitrakvi on 19 September 2019
Marketing authorisations
EMA — authorised 19 September 2019
- Application: EMEA/H/C/004919
- Marketing authorisation holder: Bayer AG
- Local brand name: Vitrakvi
- Indication: Vitrakvi as monotherapy is indicated for the treatment of adult and paediatric patients with solid tumours that display a Neurotrophic Tyrosine Receptor Kinase (NTRK) gene fusion, who have a disease that is locally advanced, metastatic or where surgical resection is likely to result in severe morbidity, and who have no satisfactory treatment options.
- Pathway: conditional
- Status: approved
Vitrakvi 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 Vitrakvi approved in European Union?
Yes. EMA authorised it on 19 September 2019; EMA authorised it on 19 September 2019.
Who is the marketing authorisation holder for Vitrakvi in European Union?
Bayer AG holds the EU marketing authorisation.