🇪🇺 Recombinant Human Adenovirus Type 5 Injection in European Union

EMA authorised Recombinant Human Adenovirus Type 5 Injection on 20 February 2023

Marketing authorisation

EMA — authorised 20 February 2023

  • Application: EMEA/H/C/004650
  • Marketing authorisation holder: AstraZeneca AB
  • Local brand name: Tremelimumab AstraZeneca
  • Indication: Tremelimumab AstraZeneca in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.
  • Status: withdrawn

Read official source →

Recombinant Human Adenovirus Type 5 Injection 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 Recombinant Human Adenovirus Type 5 Injection approved in European Union?

Yes. EMA authorised it on 20 February 2023.

Who is the marketing authorisation holder for Recombinant Human Adenovirus Type 5 Injection in European Union?

AstraZeneca AB holds the EU marketing authorisation.