🇪🇺 Leukine in European Union

Leukine (SARGRAMOSTIM) regulatory status in European Union.

Marketing authorisation

EMA

  • Application: EMEA/H/C/006411
  • Local brand name: Imreplys
  • Status: approved

Leukine 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 Leukine approved in European Union?

Yes. EMA has authorised it.

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

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