Is Eltrombopag olamine registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 8 valid registrations of Eltrombopag olamine, including Elbag (50 mg, Film-coated tablet, SAR 4610.35); Elbag (25 mg, Film-coated tablet, SAR 2305.15); REVOLADE 25MG FILM COATED TABLET (25 mg, Film-coated tablet, SAR 2469.80); REVOLADE 50MG FILM COATED TABLET (50 mg, Film-coated tablet, SAR 4939.70); Ropirage (25 mg, Film-coated tablet, SAR 1975.85).

Is Eltrombopag olamine approved by the US FDA?

Drugs@FDA lists 14 application product lines for Eltrombopag olamine, including PROMACTA (Prescription); PROMACTA KIT (Prescription); ELTROMBOPAG OLAMINE (Prescription); ELTROMBOPAG OLAMINE (Prescription); ELTROMBOPAG OLAMINE (Prescription).

Is Eltrombopag olamine authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Eltrombopag olamine: Eltrombopag Viatris, Eltrombopag Accord.

Are there safety signals or safety updates for Eltrombopag olamine?

US FDA: 3 entries (latest 2025-06-06).

Active substance

Eltrombopag olamine

SFDA 10
US FDA 14
EMA 2
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
Elbag	50 mg	Film-coated tablet · Oral use	28 Blister	SAR 4610.35	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Elbag	25 mg	Film-coated tablet · Oral use	28 Blister	SAR 2305.15	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
REVOLADE 25MG FILM COATED TABLET	25 mg	Film-coated tablet · Oral use	28 Blister	SAR 2469.80	NCE · Prescription	NOVARTIS PHARMA AG	Valid
REVOLADE 50MG FILM COATED TABLET	50 mg	Film-coated tablet · Oral use	28 Blister	SAR 4939.70	NCE · Prescription	NOVARTIS PHARMA AG	Valid
Ropirage	25 mg	Film-coated tablet · Oral use	28 Blister	SAR 1975.85	Generic · Prescription	APOTEX INC. (SIGNET SITE)	Valid
Ropirage	50 mg	Film-coated tablet · Oral use	28 Blister	SAR 3951.75	Generic · Prescription	APOTEX INC. (SIGNET SITE)	Valid
Trompolate	50 mg	Film-coated tablet · Oral use	30 Blister	SAR 4586.85	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
Trompolate	25 mg	Film-coated tablet · Oral use	30 Blister	SAR 2293.40	Generic · Prescription	SUDAIR PHARMA COMPANY	Valid
REVOLADE 25MG FILM COATED TABLET	25 mg	Film-coated tablet · Oral use	28 Blister	SAR 5527.00	NCE · Prescription	GLAXO	Withdrawn by MAH · Not Marketed
REVOLADE 50MG FILM COATED TABLET	50 mg	Film-coated tablet · Oral use	28 Blister	SAR 11054.05	NCE · Prescription	GLAXO	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

APLASTIC ANEMIA; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); IMMUNE THROMBOCYPTOPENIC PUPURA; MYELODYSPLASTIC SYNDROMES- ANEMIA

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

Product	Strength	Form · route	Applicant	Status	First approved
PROMACTA	EQ 25MG ACID; EQ 50MG ACID; EQ 75MG ACID; EQ 12.5MG ACID	tablet · oral	NOVARTIS	Prescription	20 Nov 2008
PROMACTA KIT	EQ 25MG ACID/PACKET; EQ 12.5MG ACID/PACKET	for suspension · oral	NOVARTIS	Prescription	24 Aug 2015
ELTROMBOPAG OLAMINE	EQ 12.5MG ACID/PACKET; EQ 25MG ACID/PACKET	for suspension · oral	ANNORA PHARMA	Prescription	18 Apr 2024
ELTROMBOPAG OLAMINE	EQ 12.5MG ACID; EQ 25MG ACID; EQ 50MG ACID; EQ 75MG ACID	tablet · oral	HETERO LABS LTD V	Prescription	17 Jan 2025
ELTROMBOPAG OLAMINE	EQ 12.5MG ACID; EQ 50MG ACID; EQ 25MG ACID; EQ 75MG ACID	tablet · oral	AMNEAL	Prescription	14 Jan 2026
ELTROMBOPAG OLAMINE	EQ 12.5MG ACID; EQ 25MG ACID; EQ 50MG ACID; EQ 75MG ACID	tablet · oral	ZYDUS PHARMS	Prescription	14 Jan 2026
ELTROMBOPAG OLAMINE	EQ 12.5MG ACID; EQ 25MG ACID; EQ 50MG ACID; EQ 75MG ACID	tablet · oral	SOMERSET THERAPS LLC	Prescription	14 Jan 2026
ELTROMBOPAG OLAMINE	EQ 12.5MG ACID; EQ 25MG ACID; EQ 50MG ACID; EQ 75MG ACID	tablet · oral	MSN	Prescription	14 Jan 2026
ELTROMBOPAG OLAMINE	EQ 12.5MG ACID; EQ 25MG ACID; EQ 50MG ACID; EQ 75MG ACID	tablet · oral	DR REDDYS	Prescription	16 Mar 2026
ELTROMBOPAG OLAMINE	EQ 12.5MG ACID; EQ 25MG ACID; EQ 50MG ACID; EQ 75MG ACID	tablet · oral	HIKMA PHARMS	Prescription	8 Apr 2026
ELTROMBOPAG OLAMINE	EQ 12.5MG ACID; EQ 25MG ACID; EQ 50MG ACID; EQ 75MG ACID	tablet · oral	BIOCON PHARMA	Prescription	28 Apr 2026
ELTROMBOPAG OLAMINE	EQ 50MG ACID	tablet · oral	ACTAVIS LABS FL	Prescription	17 Jun 2026
ELTROMBOPAG OLAMINE	EQ 12.5MG ACID; EQ 25MG ACID; EQ 75MG ACID	tablet · oral	TEVA PHARMS USA	Prescription	13 Jul 2026
PROMACTA	EQ 100MG ACID Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	tablet · oral	NOVARTIS	Discontinued	20 Nov 2008

EMA European Union — centrally authorised medicines

Eltrombopag Viatris Viatris Limited · Authorised · authorised 12 Dec 2024 · ATC B02BX05

Therapeutic indication (EMA)

Eltrombopag Viatris is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).Eltrombopag Viatris is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1).Eltrombopag Viatris is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy (see sections 4.2 and 5.1).

Eltrombopag Accord Accord Healthcare S.L.U. · Authorised · authorised 28 Mar 2025 · ATC B02BX05

Therapeutic indication (EMA)

Eltrombopag Accord is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).Eltrombopag Accord is indicated for the treatment of paediatric patients aged 1 year and above with primary immune thrombocytopenia (ITP) lasting 6 months or longer from diagnosis and who are refractory to other treatments (e.g. corticosteroids, immunoglobulins).Eltrombopag Accord is indicated in adult patients with chronic hepatitis C virus (HCV) infection for the treatment of thrombocytopenia, where the degree of thrombocytopenia is the main factor preventing the initiation or limiting the ability to maintain optimal interferon-based therapy.

Safety signals and safety-related labeling changes

US FDA 6 Jun 2025 PROMACTA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 6 Jun 2025 PROMACTA KIT — 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
US FDA 24 Jul 2018 PROMACTA — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for eltrombopag olamine →

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.