🇪🇺 COLUMVI in European Union

EMA authorised COLUMVI on 7 July 2023

Marketing authorisation

EMA — authorised 7 July 2023

  • Application: EMEA/H/C/005751
  • Marketing authorisation holder: Roche Registration GmbH
  • Local brand name: Columvi
  • Indication: Columvi in combination with gemcitabine and oxaliplatin is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma not otherwise specified (DLBCL NOS) who are ineligible for autologous stem cell transplant (ASCT).Columvi as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B cell lymphoma (DLBCL), after two or more lines of systemic therapy.
  • Status: approved

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COLUMVI 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 COLUMVI approved in European Union?

Yes. EMA authorised it on 7 July 2023.

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

Roche Registration GmbH holds the EU marketing authorisation.