Doptelet

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avatrombopag

Authorised
This medicine is authorised for use in the European Union.

Overview

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.

This EPAR was last updated on 28/01/2021

Authorisation details

Product details
Name
Doptelet
Agency product number
EMEA/H/C/004722
Active substance
avatrombopag maleate
International non-proprietary name (INN) or common name
avatrombopag
Therapeutic area (MeSH)
Thrombocytopenia
Anatomical therapeutic chemical (ATC) code
B02BX
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Publication details
Marketing-authorisation holder
Swedish Orphan Biovitrum AB (publ)
Revision
3
Date of issue of marketing authorisation valid throughout the European Union
20/06/2019
Contact address

SE-112 76 Stockholm
Sweden

Product information

18/01/2021 Doptelet - EMEA/H/C/004722 - II/0004/G

Contents

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Pharmacotherapeutic group

Antihemorrhagics

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).

Assessment history

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