Regulatory PathRegulatory requirements compared

Active substance

Rivaroxaban

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
BANORIV 10 mg Film Coated Tablet10 mgFilm-coated tablet · Oral use10 BlisterSAR 71.30Generic · PrescriptionSPIMACO ADDWAEIHValid
BANORIV 15MG F.C.TABLET15 mgFilm-coated tablet · Oral use28 BlisterSAR 186.30Generic · PrescriptionSPIMACO ADDWAEIHValid
BANORIV 2.5 mg Film Coated Tablet2.5 mgFilm-coated tablet · Oral use10 BlisterSAR 31.70Generic · PrescriptionSPIMACO ADDWAEIHValid
BANORIV 2.5MG F.C.TABLET2.5 mgFilm-coated tablet · Oral use60 BlisterSAR 190.20Generic · PrescriptionSPIMACO ADDWAEIHValid
BANORIV 20 mg Film Coated Tablet20 mgFilm-coated tablet · Oral use28 BlisterSAR 199.60Generic · PrescriptionSPIMACO ADDWAEIHValid
Extaq10 mgFilm-coated tablet · Oral use10 BlisterSAR 39.75Generic · PrescriptionAl-Taqaddom pharmaceutical IndustriesValid
Extaq10 mgFilm-coated tablet · Oral use30 BlisterSAR 103.10Generic · PrescriptionAl-Taqaddom pharmaceutical IndustriesValid
Extaq15 mgFilm-coated tablet · Oral use28 BlisterSAR 142.75Generic · PrescriptionAl-Taqaddom pharmaceutical IndustriesValid
Extaq20 mgFilm-coated tablet · Oral use28 BlisterSAR 142.75Generic · PrescriptionAl-Taqaddom pharmaceutical IndustriesValid
Harfib10 mgTablet · Oral use30 BlisterSAR 179.70Generic · PrescriptionPharma Pharmaceutical Industries (PPI)Valid
Harfib15 mgTablet · Oral use30 BlisterSAR 179.70Generic · PrescriptionPharma Pharmaceutical Industries (PPI)Valid
Harfib20 mgTablet · Oral use30 BlisterSAR 179.70Generic · PrescriptionPharma Pharmaceutical Industries (PPI)Valid
LIBSA20 mgFilm-coated tablet · Oral use30 BlisterSAR 179.70Generic · PrescriptionALPHA PHARMA INDUSTRYValid
Libsa15 mgFilm-coated tablet · Oral use30 BlisterSAR 179.70Generic · PrescriptionALPHA PHARMA INDUSTRYValid
Libsa10 mgFilm-coated tablet · Oral use30 BlisterSAR 192.45Generic · PrescriptionALPHA PHARMA INDUSTRYValid
Libsa10 mgFilm-coated tablet · Oral use10 BlisterSAR 64.15Generic · PrescriptionALPHA PHARMA INDUSTRYValid
Rivaroxaban MCP20 mgFilm-coated tablet · Oral use28 BlisterSAR 167.70Generic · PrescriptionMed City PharmaValid
Rivaroxaban MCP10 mgFilm-coated tablet · Oral use10 BlisterSAR 64.15Generic · PrescriptionMed City PharmaValid
Rivaroxaban MCP15 mgFilm-coated tablet · Oral use28 BlisterSAR 167.70Generic · PrescriptionMed City PharmaValid
Rivaroxaban SPC10 mgFilm-coated tablet · Oral use10 BlisterSAR 44.90Generic · PrescriptionSUDAIR PHARMA COMPANYValid
Rivaroxaban SPC15 mgFilm-coated tablet · Oral use42 BlisterSAR 176.10Generic · PrescriptionSUDAIR PHARMA COMPANYValid
Rivaroxaban SPC20 mgFilm-coated tablet · Oral use28 BlisterSAR 125.70Generic · PrescriptionSUDAIR PHARMA COMPANYValid
Rivaroxo10 mgFilm-coated tablet · Oral use30 BlisterSAR 179.70Generic · PrescriptionSAUDI PHARMACEUTICAL INDUSTRIESValid
Rivax20 mgFilm-coated tablet · Oral use30 BlisterSAR 192.45Generic · PrescriptionSaudi AmaroxValid
Rivax15 mgFilm-coated tablet · Oral use30 BlisterSAR 179.70Generic · PrescriptionSaudi AmaroxValid

24 more — full table

Indications — CHI Daman Drug Formulary

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

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

ProductStrengthForm · routeApplicantStatusFirst approved
XARELTO10MG; 15MG; 20MG; 2.5MGtablet · oralJANSSEN PHARMSPrescription1 Jul 2011
XARELTO10MG; 15MG; 20MG; 2.5MGtablet · oralJANSSEN PHARMSPrescription4 Nov 2011
XARELTO1MG/MLfor suspension · oralJANSSEN PHARMSPrescription20 Dec 2021
RIVAROXABAN2.5MG; 10MG; 15MG; 20MGtablet · oralLUPINPrescription3 Mar 2025
RIVAROXABAN2.5MG; 10MG; 15MG; 20MGtablet · oralTAROPrescription3 Mar 2025
RIVAROXABAN2.5MG; 10MG; 15MG; 20MGtablet · oralAUROBINDO PHARMA LTDPrescription10 Apr 2025
RIVAROXABAN2.5MGtablet · oralAPOTEXPrescription2 May 2025
RIVAROXABAN2.5MG; 10MG; 15MG; 20MGtablet · oralDR REDDYSPrescription14 May 2025
RIVAROXABAN2.5MG; 10MG; 15MG; 20MGtablet · oralALEMBICPrescription14 May 2025
RIVAROXABAN2.5MG; 10MG; 15MG; 20MGtablet · oralMACLEODS PHARMSPrescription14 May 2025
RIVAROXABAN10MG; 15MG; 20MGtablet · oralSUNSHINEPrescription14 May 2025
RIVAROXABAN10MG; 15MG; 20MGtablet · oralAIPING PHARM INCPrescription14 May 2025
RIVAROXABAN2.5MG; 10MG; 15MG; 20MGtablet · oralBIOCON PHARMAPrescription14 May 2025
RIVAROXABAN2.5MG; 10MG; 15MG; 20MGtablet · oralASCENT PHARMS INCPrescription14 May 2025
RIVAROXABAN10MG; 15MG; 20MGtablet · oralBRECKENRIDGEPrescription15 May 2025
RIVAROXABAN1MG/MLfor suspension · oralALKEM LABS LTDPrescription26 Jun 2025
RIVAROXABAN2.5MG; 10MG; 15MG; 20MGtablet · oralSCIEGEN PHARMSPrescription31 Jul 2025
RIVAROXABAN2.5MG; 10MG; 15MG; 20MGtablet · oralREGCON HOLDINGSPrescription11 Aug 2025
RIVAROXABAN1MG/MLfor suspension · oralLUPINPrescription25 Sep 2025
RIVAROXABAN2.5MGtablet · oralMSNPrescription24 Oct 2025
RIVAROXABAN2.5MGtablet · oralINVAGEN PHARMSPrescription20 Feb 2026
RIVAROXABAN2.5MG; 10MG; 15MG; 20MGtablet · oralMICRO LABSPrescription30 Jun 2026
RIVAROXABAN2.5MG; 10MG; 15MG; 20MGtablet · oralMANKIND PHARMAPrescription1 Jul 2026
RIVAROXABAN2.5MG; 10MG; 15MG; 20MGtablet · oralEPIC PHARMA LLCPrescription19 Aug 2026
RIVAROXABAN10MG; 15MG; 20MGtablet · oralINVAGEN PHARMSDiscontinued14 May 2025

3 more — full table

EMA European Union — centrally authorised medicines

Xarelto Bayer AG · Authorised · authorised 30 Sep 2008 · ATC B01AF01

Therapeutic indication (EMA)

Xarelto, co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. Xarelto, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Rivaroxaban Accord Accord Healthcare S.L.U. · Authorised · authorised 16 Nov 2020 · ATC B01AF01

Therapeutic indication (EMA)

Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients). Adults Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA) alone or with ASA plus ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers (see sections 4.3, 4.4 and 5.1). Rivaroxaban Accord, co administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Rivaroxaban Viatris (previously Rivaroxaban Mylan) Viatris Limited · Authorised · authorised 12 Nov 2021 · ATC B01AF01

Therapeutic indication (EMA)

Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine, is indicated for the prevention of atherothrombotic events in adult patients after an acute coronary syndrome (ACS) with elevated cardiac biomarkers. Rivaroxaban Mylan co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in adult patients with coronary artery disease (CAD) or symptomatic peripheral artery disease (PAD) at high risk of ischaemic events. ------ Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. ------- Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ? 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment.

Svariya (previously Rivaroxaban Koanaa) PGF Pharma International d.o.o. · Authorised · authorised 21 Nov 2025 · ATC B01AF01

Therapeutic indication (EMA)

Prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients). Prevention of atherothrombotic events Adults prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients.) Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing more than 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Adults prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation with one or more risk factors, such as congestive heart failure, hypertension, age ≥ 75 years, diabetes mellitus, prior stroke or transient ischaemic attack. Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults. (See section 4.4 for haemodynamically unstable PE patients). Paediatric population Treatment of venous thromboembolism (VTE) and prevention of VTE recurrence in children and adolescents aged less than 18 years and weighing from 30 kg to 50 kg after at least 5 days of initial parenteral anticoagulation treatment. Svariya films should not be prescribed for patients with body weight less than 30 kg.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AG-RIVAROXABAN0252799510 MGTABLET · ORALANGITA PHARMA INC.
AG-RIVAROXABAN0252800215 MGTABLET · ORALANGITA PHARMA INC.
AG-RIVAROXABAN0252801020 MGTABLET · ORALANGITA PHARMA INC.
AG-RIVAROXABAN025552552.5 MGTABLET · ORALANGITA PHARMA INC.
APO-RIVAROXABAN0247049710 MGTABLET · ORALAPOTEX INC
APO-RIVAROXABAN0247050015 MGTABLET · ORALAPOTEX INC
APO-RIVAROXABAN0247051920 MGTABLET · ORALAPOTEX INC
APO-RIVAROXABAN025417342.5 MGTABLET · ORALAPOTEX INC
AURO-RIVAROXABAN0256035610 MGTABLET · ORALAURO PHARMA INC
AURO-RIVAROXABAN0256036415 MGTABLET · ORALAURO PHARMA INC
BIO-RIVAROXABAN025493282.5 MGTABLET · ORALBIOMED PHARMA
BIO-RIVAROXABAN0254933610 MGTABLET · ORALBIOMED PHARMA
BIO-RIVAROXABAN0254934415 MGTABLET · ORALBIOMED PHARMA
BIO-RIVAROXABAN0254935220 MGTABLET · ORALBIOMED PHARMA
JAMP RIVAROXABAN0251629210 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP RIVAROXABAN0251630615 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP RIVAROXABAN0251631420 MGTABLET · ORALJAMP PHARMA CORPORATION
JAMP RIVAROXABAN025533682.5 MGTABLET · ORALJAMP PHARMA CORPORATION
M-RIVAROXABAN025516082.5 MGTABLET · ORALMANTRA PHARMA INC
M-RIVAROXABAN0255161610 MGTABLET · ORALMANTRA PHARMA INC
M-RIVAROXABAN0255162415 MGTABLET · ORALMANTRA PHARMA INC
M-RIVAROXABAN0255163220 MGTABLET · ORALMANTRA PHARMA INC
NB-RIVAROXABAN025551072.5 MGTABLET · ORALNB PHARMA INC.
NB-RIVAROXABAN0255511510 MGTABLET · ORALNB PHARMA INC.
NB-RIVAROXABAN0255512315 MGTABLET · ORALNB PHARMA INC.

43 more — full table

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACRIVAROXABAN 1 MG/ML SUSPENSION$1.78883per ML23 Sep 2026
US NADACRIVAROXABAN 2.5 MG TABLET$0.64963per EA7 Oct 2026
US NADACXARELTO 1 MG/ML SUSPENSION$3.77426per ML23 Sep 2026
US NADACXARELTO 10 MG TABLET$19.52226per EA23 Sep 2026
US NADACXARELTO 15 MG TABLET$19.53519per EA23 Sep 2026
US NADACXARELTO 2.5 MG TABLET$9.77474per EA23 Sep 2026
US NADACXARELTO 20 MG TABLET$19.54187per EA23 Sep 2026
NHS Drug TariffRivaroxaban 10mg capsules£45.3628 capsule1 Oct 2026
NHS Drug TariffRivaroxaban 10mg tablets£1.1530 tablet1 Oct 2026
NHS Drug TariffRivaroxaban 15mg capsules£45.3628 capsule1 Oct 2026
NHS Drug TariffRivaroxaban 15mg tablets£0.9728 tablet1 Oct 2026
NHS Drug TariffRivaroxaban 15mg tablets and Rivaroxaban 20mg tablets£88.2049 tablet1 Oct 2026
NHS Drug TariffRivaroxaban 1mg/ml granules for oral suspension sugar free£18.00103.4 ml1 Oct 2026
NHS Drug TariffRivaroxaban 2.5mg tablets£0.8356 tablet1 Oct 2026
NHS Drug TariffRivaroxaban 20mg capsules£45.3628 capsule1 Oct 2026
NHS Drug TariffRivaroxaban 20mg tablets£0.9628 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.

WHO WHO Model List of Essential Medicines (2025)

  • 10.2. Medicines affecting coagulation · core
    Therapeutic equivalent to dabigatran for Other specified atrial fibrillation; Therapeutic equivalent to dabigatran for Venous thromboembolism

Safety signals and safety-related labeling changes

All safety entries for rivaroxaban →

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.