🇪🇺 MSC2156119J in European Union

EMA authorised MSC2156119J on 16 February 2022

Marketing authorisation

EMA — authorised 16 February 2022

  • Application: EMEA/H/C/005524
  • Marketing authorisation holder: Merck Europe B.V.
  • Local brand name: Tepmetko
  • Indication: Tepmetko 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

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Frequently asked questions

Is MSC2156119J approved in European Union?

Yes. EMA authorised it on 16 February 2022.

Who is the marketing authorisation holder for MSC2156119J in European Union?

Merck Europe B.V. holds the EU marketing authorisation.