🇪🇺 Palbociclib in European Union

Palbociclib (palbociclib) regulatory status in European Union.

Marketing authorisations

EMA

  • Local brand name: Palbociclib
  • Status: approved

EMA

  • Application: EMEA/H/C/003853
  • Local brand name: Ibrance
  • Status: approved

Palbociclib 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 Palbociclib approved in European Union?

Yes. EMA has authorised it; EMA has authorised it.

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

Pfizer Inc. is the originator. The local marketing authorisation holder may differ — check the official source linked above.