🇪🇺 Rituximab Injection in European Union

EMA authorised Rituximab Injection on 15 June 2017

Marketing authorisation

EMA — authorised 15 June 2017

  • Application: EMEA/H/C/003903
  • Marketing authorisation holder: Sandoz GmbH
  • Local brand name: Rixathon
  • Indication: Rixathon is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Rixathon is indicated for the treatment of previously untreated adult patients with stage III-IV follicular lymphoma in combination with chemotherapy. Rixathon maintenance therapy is indicated for the treatment of adult follicular lymphoma patients responding to induction therapy. Rixathon monotherapy is indicated for treatment of adult patients with stage III-IV follicular lymphoma who are chemoresistant or are in their second or subsequent relapse after chemotherapy. Rixathon is indicated for the trea
  • Pathway: biosimilar
  • Status: approved

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Rituximab 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 Rituximab Injection approved in European Union?

Yes. EMA authorised it on 15 June 2017.

Who is the marketing authorisation holder for Rituximab Injection in European Union?

Sandoz GmbH holds the EU marketing authorisation.