🇪🇺 Rubraca in European Union

EMA authorised Rubraca on 23 May 2018

Marketing authorisations

EMA — authorised 23 May 2018

  • Application: EMEA/H/C/004272
  • Marketing authorisation holder: pharmaand GmbH
  • Local brand name: Rubraca
  • Indication: Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with advanced (FIGO Stages III and IV) high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy. Rubraca is indicated as monotherapy for the maintenance treatment of adult patients with platinum-sensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum-based chemotherapy.
  • Status: approved

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EMA

  • Status: approved

Rubraca 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 Rubraca approved in European Union?

Yes. EMA authorised it on 23 May 2018; EMA has authorised it.

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

pharmaand GmbH holds the EU marketing authorisation.