Is Avatrombopag registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Avatrombopag, including Doptelet (20 mg, Film-coated tablet, SAR 2979.95).

Is Avatrombopag approved by the US FDA?

Drugs@FDA lists 2 application product lines for Avatrombopag, including DOPTELET (Prescription); DOPTELET SPRINKLE (Prescription).

Is Avatrombopag authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Avatrombopag: Doptelet.

Are there safety signals or safety updates for Avatrombopag?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2025-07-24).

Active substance

Avatrombopag

SFDA 3
US FDA 2
EMA 1
Health Canada 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Doptelet	20 mg	Film-coated tablet · Oral use	10 Blister	SAR 2979.95	NCE · Prescription	SWEDISH ORPHAN BIOVITRUM INTERNATIONAL AB	Valid
Doptelet	20 mg	Film-coated tablet · Oral use	15 Blister	SAR 4470.25	NCE · Prescription	SWEDISH ORPHAN BIOVITRUM INTERNATIONAL AB	Valid
Doptelet	20 mg	Film-coated tablet · Oral use	30 Blister	SAR 8941.10	NCE · Prescription	SWEDISH ORPHAN BIOVITRUM INTERNATIONAL AB	Valid

Indications — CHI Daman Drug Formulary

IMMUNE THROMBOCYPTOPENIC PUPURA

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
DOPTELET	EQ 20MG BASE	tablet · oral	AKARX INC	Prescription	21 May 2018
DOPTELET SPRINKLE	EQ 10MG BASE	granule · oral	AKARX INC	Prescription	24 Jul 2025

EMA European Union — centrally authorised medicines

Doptelet Swedish Orphan Biovitrum AB (publ) · Authorised · authorised 20 Jun 2019 · ATC B02BX

Therapeutic indication (EMA)

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 Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
DOPTELET	02542706	20 MG	TABLET · ORAL	SWEDISH ORPHAN BIOVITRUM AB (PUBL)

Safety signals and safety-related labeling changes

US FDA 24 Jul 2025 DOPTELET — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 11 Jan 2024 PRAC signal: Antiphospholipid syndrome
Action for MAH: update of the product information: Yes
EMA PRAC 31 Aug 2023 PRAC signal: Antiphospholipid syndrome
Action for MAH: update of the product information: No

All safety entries for avatrombopag →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.