Human medicines European public assessment report (EPAR): Doptelet, avatrombopag, Date of authorisation: 20/06/2019, Revision: 11, Status: Authorised

Doptelet RSS Authorised This medicine is authorised for use in the European Union avatrombopag Medicine Human Authorised Application under evaluation CHMP opinion European Commission decision 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. Expand section Collapse section How is Doptelet used? Doptelet can only be obtained with a prescription. It is available as 20-mg tablets. Treatment with Doptelet should start at least 10 days before the procedure. The dose is 2 or 3 tablets (depending on the platelet count at the start of treatment), daily for 5 days. A blood test on the day of the procedure is necessary to ensure that the platelet count is adequate and not unexpectedly high. For more information about using Doptelet, see the package leaflet or contact your doctor or pharmacist. How does Doptelet work? In the body, a hormone called thrombopoietin stimulates the production of platelets by attaching to receptors (targets) in the bone marrow. The active substance in Doptelet, avatrombopag, attaches to the same receptors as thrombopoietin, helping to increase the platelet count. What benefits of Doptelet have been shown in studies? Two main studies in 435 patients with low levels of platelets due to long-standing liver disease found Doptelet effective at increasing platelet levels before an invasive procedure. The main measure of effectiveness was the number of patients who did not require a transfusion of platelets or other treatment ('rescue procedure') to prevent excessive bleeding after starting Doptelet treatment and for up to 7 days after their invasive procedure. In these studies, 88% of patients who received Doptelet 40 mg daily did not require a transfusion or rescue procedure compared with 36% of patients who were given placebo (a dummy treatment). Among patients with more severe thrombocytopenia, 67% of those given Doptelet 60 mg daily did not require a transfusion or rescue procedure compared with 29% of those who received placebo. What are the risks associated with Doptelet? The most common side effect with Doptelet (which may affect up to 1 in 10 people) is tiredness. For the full list of side effects and restrictions with Doptelet, see the package leaflet. Why is Doptelet authorised in the EU? Studies have found that Doptelet reduced the need for platelet transfusions or other rescue treatments to prevent excessive bleeding before an invasive procedure and for up to 7 days afterward. The platelet count increased in patients treated with Doptelet. Any unwanted effects during treatment with Doptelet were thought to result from patients’ medical condition and the nature of the invasive procedure for which it was used. The European Medicines Agency decided that Doptelet’s benefits are greater than its risks and it can be authorised for use in the EU. What measures are being taken to ensure the safe and effective use of Doptelet? Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Doptelet have been included in the summary of product characteristics and the package leaflet. As for all medicines, data on the use of Doptelet are continuously monitored. Side effects reported with Doptelet are carefully evaluated and any necessary action taken to protect patients. Other information about Doptelet Doptelet received a marketing authorisation valid throughout the EU on 20 June 2019. Doptelet : EPAR - Medicine overview Reference Number: EMA/243810/2019 English (EN) (104.1 KB - PDF) First published: 25/06/2019 View Other languages (22) български (BG) (169.05 KB - PDF) First published: 25/06/2019 View español (ES) (145 KB - PDF) First published: 25/06/2019 View čeština (CS) (167.7 KB - PDF) First published: 25/06/2019 View dansk (DA) (142.64 KB - PDF) First published: 25/06/2019 View Deutsch (DE) (146.37 KB - PDF) First published: 25/06/2019 View eesti keel (ET) (132.67 KB - PDF) First published: 25/06/2019 View ελληνικά (EL) (170.53 KB - PDF) First published: 25/06/2019 View français (FR) (146 KB - PDF) First published: 25/06/2019 View hrvatski (HR) (166.15 KB - PDF) First published: 25/06/2019 View italiano (IT) (142.96 KB - PDF) First published: 25/06/2019 View latviešu valoda (LV) (174.69 KB - PDF) First published: 25/06/2019 View lietuvių kalba (LT) (166.18 KB - PDF) First published: 25/06/2019 View magyar (HU) (166.99 KB - PDF) First published: 25/06/2019 View Malti (MT) (169.54 KB - PDF) First published: 25/06/2019 View Nederlands (NL) (144.45 KB - PDF) First published: 25/06/2019 View polski (PL) (171.38 KB - PDF) First published: 25/06/2019 View português (PT) (145.48 KB - PDF) First published: 25/06/2019 View română (RO) (164.96 KB - PDF) First published: 25/06/2019 View slovenčina (SK) (167.13 KB - PDF) First published: 25/06/2019 View slovenščina (SL) (163.94 KB - PDF) First published: 25/06/2019 View Suomi (FI) (142.78 KB - PDF) First published: 25/06/2019 View svenska (SV) (143.17 KB - PDF) First published: 25/06/2019 View Doptelet : EPAR - Risk-management-plan summary English (EN) (293.18 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View Product information Doptelet : EPAR - Product information English (EN) (322.06 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View Other languages (24) български (BG) (459.11 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View español (ES) (321.92 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View čeština (CS) (407.65 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View dansk (DA) (304.43 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View Deutsch (DE) (330.38 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View eesti keel (ET) (308.38 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View ελληνικά (EL) (545.72 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View français (FR) (320.22 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View hrvatski (HR) (392.07 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View íslenska (IS) (304.54 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View italiano (IT) (317.62 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View latviešu valoda (LV) (410.63 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View lietuvių kalba (LT) (425.35 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View magyar (HU) (413.19 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View Malti (MT) (498.55 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View Nederlands (NL) (314 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View norsk (NO) (328.96 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View polski (PL) (421.85 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View português (PT) (347.52 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View română (RO) (420.91 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View slovenčina (SK) (426.22 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View slovenščina (SL) (389.44 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View Suomi (FI) (306 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View svenska (SV) (327.44 KB - PDF) First published: 25/06/2019 Last updated: 18/06/2025 View Latest procedure affecting product information: VR/0000255149 22/05/2025 This medicine’s product information is available in all official EU languages . Select 'available languages' to access the language you need. Product information documents contain: summary of product characteristics (annex I); manufacturing authorisation holder responsible for batch release (annex IIA); conditions of the marketing authorisation (annex IIB); labelling (annex IIIA); package leaflet (annex IIIB). Doptelet : EPAR - All authorised presentations English (EN) (17.2 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View Other languages (24) български (BG) (40.22 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View español (ES) (17.33 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View čeština (CS) (41.16 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View dansk (DA) (22.04 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View Deutsch (DE) (17.07 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View eesti keel (ET) (17.15 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View ελληνικά (EL) (40.1 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View français (FR) (17.12 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View hrvatski (HR) (26.21 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View íslenska (IS) (16.95 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View italiano (IT) (17.21 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View latviešu valoda (LV) (39.09 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View lietuvių kalba (LT) (39.28 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View magyar (HU) (25.48 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View Malti (MT) (35.47 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View Nederlands (NL) (17.1 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View norsk (NO) (17.17 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View polski (PL) (28.14 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View português (PT) (17.17 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View română (RO) (37.28 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View slovenčina (SK) (27.04 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View slovenščina (SL) (25.6 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View Suomi (FI) (17.13 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View svenska (SV) (17.01 KB - PDF) First published: 25/06/2019 Last updated: 28/01/2021 View Product details Name of medicine Doptelet Active substance avatrombopag maleate International non-proprietary name (INN) or common name avatrombopag Therapeutic area (MeSH) Thrombocytopenia Anatomical therapeutic chemical (ATC) code B02BX 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). Authorisation details EMA product number EMEA/H/C/004722 Marketing authorisation holder Swedish Orphan Biovitrum AB (publ) SE-112 76 Stockholm Sweden Opinion adopted 26/04/2019 Marketing authorisation issued 20/06/2019 Revision 11 Assessment history Expand section Collapse section Changes since initial authorisation of medicine Doptelet : EPAR - Procedural steps taken and scientific information after the authorisation English (EN) (175.23 KB - PDF) First published: 18/06/2025 Last updated: 08/04/2026 View Doptelet : EPAR - Procedural steps taken and scientific information after the authorisation (archive) English (EN) (126.55 KB - PDF) First published: 27/01/2020 Last updated: 18/06/2025 View Doptelet : EPAR - Statement indicating compliance with the agreed completed paediatric investigation plan Reference Number: EMADOC-1700519818-3014602 English (EN) (143.5 KB - PDF) First published: 08/04/2026 View Doptelet-H-C-004722-P46-007 : EPAR - Assessment report - Variation Reference Number: EMA/369609/2024 English (EN) (1.25 MB - PDF) First published: 13/08/2024 View Doptelet-H-C-PSUSA-00010779-202005 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation Reference Number: EMA/CHMP/197652/2021 English (EN) (126.76 KB - PDF) First published: 07/04/2021 View Doptelet-H-C-004722-II-0004-G : EPAR - Assessment report - Variation Adopted Reference Number: EMA/CHMP/7081/2021 English (EN) (11.37 MB - PDF) First published: 28/01/2021 View CHMP post-authorisation summary of positive opinion for Doptelet (II-04-G) Adopted Reference Number: EMA/CHMP/659983/2020 English (EN) (100.12 KB - PDF) First published: 11/12/2020 View Initial marketing authorisation documents Doptelet : EPAR - Public assessment report Adopted Reference Number: EMA/CHMP/322871/2019 English (EN) (5.43 MB - PDF) First published: 25/06/2019 View CHMP summary of positive opinion for Doptelet Adopted Reference Number: EMA/CHMP/208938/2019 English (EN) (113.92 KB - PDF) First published: 26/04/2019 View News on Doptelet Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 7-10 December 2020 11/12/2020 Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 23-26 April 2019 26/04/2019 More information on Doptelet EMEA-001136-PIP01-11-M03 - paediatric investigation plan EMEA-001136-PIP02-19-M01 - paediatric investigation plan Postauthorisation Safety Study (PASS) of Avatrombopag in Patients With Severe Chronic Liver Disease (CLD) - post-authorisation study Postauthorisation Safety Study (PASS) of Avatrombopag and Haematological Malignancies in Patients With Primary Immune Thrombocytopaenia - post-authorisation study Topics Medicines This page was last updated on 08/04/2026 Share this page