🇪🇺 Drug: Osimertinib in European Union

EMA authorised Drug: Osimertinib on 1 February 2016

Marketing authorisation

EMA — authorised 1 February 2016

  • Application: EMEA/H/C/004124
  • Marketing authorisation holder: AstraZeneca AB
  • Local brand name: Tagrisso
  • Indication: TAGRISSO as monotherapy is indicated for: the adjuvant treatment after complete tumour resection in adult patients with stage IB-IIIA non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations (see section 5.1). the treatment of adult patients with locally advanced, unresectable NSCLC whose tumours have EGFR exon 19 deletions or exon 21 (L858R) substitution mutations and whose disease has not progressed during or following platinum‑based chemoradiation therapy. the first-line treatment of adult pati
  • Pathway: accelerated assessment
  • Status: approved

Read official source →

Drug: Osimertinib in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Frequently asked questions

Is Drug: Osimertinib approved in European Union?

Yes. EMA authorised it on 1 February 2016.

Who is the marketing authorisation holder for Drug: Osimertinib in European Union?

AstraZeneca AB holds the EU marketing authorisation.