🇪🇺 Rituximab (R) in European Union

EMA authorised Rituximab (R) on 17 February 2017

Marketing authorisation

EMA — authorised 17 February 2017

  • Application: EMEA/H/C/004112
  • Marketing authorisation holder: Celltrion Healthcare Hungary Kft.
  • Local brand name: Truxima
  • Indication: Truxima is indicated in adults for the following indications: Non-Hodgkin’s lymphoma (NHL) Truxima is indicated for the treatment of previously untreated patients with stage III IV follicular lymphoma in combination with chemotherapy. Truxima maintenance therapy is indicated for the treatment of follicular lymphoma patients responding to induction therapy. Truxima monotherapy is indicated for treatment of patients with stage III IV follicular lymphoma who are chemo resistant or are in their second or subsequent relapse after chemotherapy. Truxima is indicated for the treatment of patients with
  • Pathway: biosimilar
  • Status: approved

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Frequently asked questions

Is Rituximab (R) approved in European Union?

Yes. EMA authorised it on 17 February 2017.

Who is the marketing authorisation holder for Rituximab (R) in European Union?

Celltrion Healthcare Hungary Kft. holds the EU marketing authorisation.