🇪🇺 Nplate in European Union

EMA authorised Nplate on 4 February 2009

Marketing authorisation

EMA — authorised 4 February 2009

  • Application: EMEA/H/C/000942
  • Marketing authorisation holder: Amgen Europe B.V.
  • Local brand name: Nplate
  • Indication: Adults: Nplate is indicated for the treatment of primary immune thrombocytopenia  (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins). Paediatrics: Nplate is indicated for the treatment of chronic primary immune thrombocytopenia (ITP) in paediatric patients one year of age and older who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
  • Status: approved

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Nplate in other countries

Same drug, different regulators. Each page below lists the local marketing authorisation, HTA position, pricing, and adverse-event data.

Other Cardiovascular approved in European Union

Frequently asked questions

Is Nplate approved in European Union?

Yes. EMA authorised it on 4 February 2009.

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

Amgen Europe B.V. holds the EU marketing authorisation.