Australia - English - Department of Health (Therapeutic Goods Administration)

swedish orphan biovitrum pty ltd - avatrombopag maleate, quantity: 23.6 mg - tablet, film coated - excipient ingredients: colloidal anhydrous silica; lactose monohydrate; microcrystalline cellulose; magnesium stearate; crospovidone; titanium dioxide; purified talc; iron oxide yellow; polyvinyl alcohol; macrogol 3350 - doptelet is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.,doptelet is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (itp) who have had an insufficient response to a previous treatment.

Israel - English - Ministry of Health

truemed ltd, israel - avatrombopag as maleate - film coated tablets - avatrombopag as maleate 20 mg - avatrombopag - for the treatment of severe thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo an invasive procedure.for the treatment of primary chronic immune thrombocytopenia (itp) in adult patients who are refractory to other treatments (e.g. corticosteroids, immunoglobulins)

European Union - English - EMA (European Medicines Agency)

swedish orphan biovitrum ab (publ) - avatrombopag maleate - thrombocytopenia - antihemorrhagics - 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).

Canada - English - Health Canada

swedish orphan biovitrum ab (publ) - avatrombopag (avatrombopag maleate) - tablet - 20mg - avatrombopag (avatrombopag maleate) 20mg

United States - English - NLM (National Library of Medicine)

akarx, inc. - avatrombopag maleate (unii: gdw7m2p1is) (avatrombopag - unii:3h8gsz4sql) - doptelet is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure. doptelet is indicated for the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment. none. risk summary based on findings from animal reproduction studies, doptelet may cause fetal harm when administered to a pregnant woman (see data ). the available data on doptelet in pregnant women are insufficient to inform a drug-associated risk of adverse developmental outcomes. in animal reproduction studies, oral administration of avatrombopag resulted in adverse developmental outcomes when administered during organogenesis in rabbits and during organogenesis and the lactation period in rats. however, these findings were observed at exposures based on an auc substantially higher than the auc observed in patients at the maximum recommended dose of 60 mg once daily. advise pregnant w

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

swedish orphan biovitrum international ab, sweden - avatrombopag - film-coated tablet - 20 mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

swedish orphan biovitrum international ab, sweden - avatrombopag - film-coated tablet - 20 mg

Saudi Arabia - English - SFDA (Saudi Food and Drug Authority)- الهيئة العامة للغذاء والدواء

swedish orphan biovitrum international ab, sweden - avatrombopag - film-coated tablet - 20 mg

Bangladesh - English - DGDA (Directorate General of Drug Administration)

jenphar bangladesh ltd. - avatrombopag - tablet - 20 mg

Japan - English - すりの適正使用協議会 RAD-AR Council, Japan

swedish orphan biovitrum japan - avatrombopag maleate - pale light yellow tablet, diameter 7.6 mm, thickness 3.8 mm