🇪🇺 Balversa in European Union

EMA authorised Balversa on 22 August 2024

Marketing authorisation

EMA — authorised 22 August 2024

  • Application: EMEA/H/C/006050
  • Marketing authorisation holder: Janssen-Cilag International N.V.
  • Local brand name: Balversa
  • Indication: Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting (see section 5.1).
  • Status: approved

The European Medicines Agency (EMA) approved Balversa, a treatment for unresectable or metastatic urothelial carcinoma (UC) in adults. This approval is for patients with UC harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor. Balversa is indicated as monotherapy for these patients.

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Balversa 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 Balversa approved in European Union?

Yes. EMA authorised it on 22 August 2024.

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

Janssen-Cilag International N.V. holds the EU marketing authorisation.