🇪🇺 Polatuzumab, bendamustin und rituximab in European Union

EMA authorised Polatuzumab, bendamustin und rituximab on 16 January 2020

Marketing authorisation

EMA — authorised 16 January 2020

  • Application: EMEA/H/C/004870
  • Marketing authorisation holder: Roche Registration GmbH
  • Local brand name: Polivy
  • Indication: Polivy in combination with bendamustine and rituximab is indicated for the treatment of adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for haematopoietic stem cell transplant. Polivy in combination with rituximab, cyclophosphamide, doxorubicin, and prednisone (R-CHP) is indicated for the treatment of adult patients with previously untreated diffuse large B-cell lymphoma (DLBCL).
  • Pathway: orphan, PRIME
  • Status: approved

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Polatuzumab, bendamustin und rituximab 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 Polatuzumab, bendamustin und rituximab approved in European Union?

Yes. EMA authorised it on 16 January 2020.

Who is the marketing authorisation holder for Polatuzumab, bendamustin und rituximab in European Union?

Roche Registration GmbH holds the EU marketing authorisation.