Regulatory PathRegulatory requirements compared

Active substance

Eltrombopag

Open in the medicines table

EMA European Union — centrally authorised medicines

Revolade Novartis Europharm Limited · Authorised · authorised 11 Mar 2010 · ATC B02BX05

Therapeutic indication (EMA)

Revolade is indicated for the treatment of adult patients with primary immune thrombocytopenia (ITP) who are refractory to other treatments (e.g. corticosteroids, immunoglobulins) (see sections 4.2 and 5.1). Revolade 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). Revolade 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 4.4 and 5.1). Revolade is indicated in adult patients with acquired severe aplastic anaemia (SAA) who were either refractory to prior immunosuppressive therapy or heavily pretreated and are unsuitable for haematopoietic stem cell transplantation (see section 5.1).

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-ELTROMBOPAG0250674225 MGTABLET · ORALAPOTEX INC
APO-ELTROMBOPAG0250676950 MGTABLET · ORALAPOTEX INC
REVOLADE0236182525 MGTABLET · ORALNOVARTIS PHARMACEUTICALS CANADA INC
REVOLADE0236183350 MGTABLET · ORALNOVARTIS PHARMACEUTICALS CANADA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACELTROMBOPAG 50 MG TABLET$25.849per EA23 Sep 2026
NHS Drug TariffEltrombopag 25mg tablets£770.0028 tablet1 Oct 2026
NHS Drug TariffEltrombopag 50mg tablets£1540.0028 tablet1 Oct 2026
NHS Drug TariffEltrombopag 75mg tablets£2310.0028 tablet1 Oct 2026

NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.

Safety signals and safety-related labeling changes

All safety entries for eltrombopag →

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.