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EMA Product

Doptelet

Product approved by European Medicines Agency (EU)

Basic Information

Doptelet

Regulatory Information

EMEA/H/C/004722

Authorised

June 20, 2019

April 26, 2019

9

November 22, 2024

Company Information

Sweden

SE-112 76 Stockholm

Swedish Orphan Biovitrum AB (Publ)

Active Substances Detail

Detailed Information

Therapeutic Indication

### Therapeutic 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).

Overview Summary

Doptelet is a medicine used to prevent excessive bleeding in adults with thrombocytopenia due to long-standing liver disease. Patients with thrombocytopenia have reduced number of platelets (components in the blood that help it to clot), which can cause excessive bleeding. The medicine is for use in patients having an invasive procedure (a medical procedure that involves cutting into or puncturing the skin or inserting instruments into the body). Doptelet contains the active substance avatrombopag.

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