🇪🇺 Mabthera in European Union

EMA authorised Mabthera on 2 June 1998

Marketing authorisation

EMA — authorised 2 June 1998

  • Marketing authorisation holder: Roche Registration GmbH
  • Status: approved

Mabthera 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 Mabthera approved in European Union?

Yes. EMA authorised it on 2 June 1998.

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

Roche Registration GmbH holds the EU marketing authorisation.