EMA — authorised 20 June 2022
- Marketing authorisation holder: NOVARTIS EUROPHARM LIMITED
- Status: approved
🇪🇺 Tabrecta in European Union
EMA authorised Tabrecta on 20 June 2022
Marketing authorisations
EMA — authorised 20 June 2022
- Application: EMEA/H/C/004845
- Marketing authorisation holder: Novartis Europharm Limited
- Local brand name: Tabrecta
- Indication: Tabrecta as monotherapy is indicated for the treatment of adult patients with advanced non small cell lung cancer (NSCLC) harbouring alterations leading to mesenchymal epithelial transition factor gene exon 14 (METex14) skipping, who require systemic therapy following prior treatment with immunotherapy and/or platinum based chemotherapy.
- Status: approved
Tabrecta 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 Tabrecta approved in European Union?
Yes. EMA authorised it on 20 June 2022; EMA authorised it on 20 June 2022.
Who is the marketing authorisation holder for Tabrecta in European Union?
NOVARTIS EUROPHARM LIMITED holds the EU marketing authorisation.