Regulatory PathRegulatory requirements compared

Active substance

Edoxaban tosilate

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
LIXIANA 15 mg film coted tablet15 mgFilm-coated tablet · Oral use14 BlisterSAR 120.00NCE · PrescriptionSAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL COValid
LIXIANA 30 mg film coted tablet30 mgFilm-coated tablet · Oral use28 BlisterSAR 240.00NCE · PrescriptionSAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL COValid
LIXIANA 60 mg film coted tablet60 mgFilm-coated tablet · Oral use28 BlisterSAR 240.00NCE · PrescriptionSAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL COValid
Indications — CHI Daman Drug Formulary

ANTIPHOSPHOLIPID SYNDROME; ATRIAL FIBRILLATION; CARDIOMYOPATHY; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; HODGKIN'S LYMPHOMA; ISCHEMIC STROKE; MANTLE CELL LYMPHOMA; MARGINAL ZONE LYMPHOMA; MULTIPLE MYELOMA; MYELOFIBROSIS-ADVERSE REACTION MANAGEMENT; POLYCYTHEMIA VERA - THROMBOSIS; PORTAL VEIN THROMBOSIS; PULMONARY ARTERIAL HYPERTENSION; PULMONARY EMBOLISM; T-CELL LYMPHOMA-RENAL TOXICITY; VENOUS THROMBOEMBOLISM DISEASE (VTE)-PROPHYLAXIS

EMA European Union — centrally authorised medicines

Lixiana Daiichi Sankyo Europe GmbH · Authorised · authorised 19 Jun 2015 · ATC B01

Therapeutic indication (EMA)

Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Roteas Berlin-Chemie AG · Authorised · authorised 19 Apr 2017 · ATC B01AF03

Therapeutic indication (EMA)

Prevention of stroke and systemic embolism in adult patients with nonvalvular atrial fibrillation (NVAF) with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack (TIA). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

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.