🇪🇺 Avatrombopag Oral Tablet in European Union

EMA authorised Avatrombopag Oral Tablet on 20 June 2019

Marketing authorisation

EMA — authorised 20 June 2019

  • Application: EMEA/H/C/004722
  • Marketing authorisation holder: Swedish Orphan Biovitrum AB (publ)
  • Local brand name: Doptelet
  • Indication: Doptelet is indicated for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure. Doptelet is indicated for the treatment of primary chronic immune thrombocytopenia (ITP) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).
  • Status: approved

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Other Hematology approved in European Union

Frequently asked questions

Is Avatrombopag Oral Tablet approved in European Union?

Yes. EMA authorised it on 20 June 2019.

Who is the marketing authorisation holder for Avatrombopag Oral Tablet in European Union?

Swedish Orphan Biovitrum AB (publ) holds the EU marketing authorisation.