🇪🇺 Zydelig in European Union

EMA authorised Zydelig on 18 September 2014

Marketing authorisation

EMA — authorised 18 September 2014

  • Application: EMEA/H/C/003843
  • Marketing authorisation holder: Gilead Sciences Ireland UC
  • Local brand name: Zydelig
  • Indication: Zydelig is indicated in combination with an anti?CD20 monoclonal antibody (rituximab or ofatumumab) for the treatment of adult patients with chronic lymphocytic leukaemia (CLL): who have received at least one prior therapy, or as first line treatment in the presence of 17p deletion or TP53 mutation in patients who are not eligible for any other therapies. Zydelig is indicated as monotherapy for the treatment of adult patients with follicular lymphoma (FL) that is refractory to two prior lines of treatment.
  • Status: approved

Read official source →

Zydelig 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 Zydelig approved in European Union?

Yes. EMA authorised it on 18 September 2014.

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

Gilead Sciences Ireland UC holds the EU marketing authorisation.