Regulatory PathRegulatory requirements compared

Active substance

Fondaparinux

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ARIXTRA 2.5MG-0.5ML PRE-FILLED SYRINGE5 mg/mlSolution for injection · Subcutaneous use10 Injection SyringeSAR 218.85NCE · PrescriptionASPEN PHARMACARE CANADA INCValid
Arixtra 7.5mg-0.6ml Pre-filled syringe12.5 mg/mlSolution for injection · Subcutaneous use10 Pre-filled syringeSAR 641.25NCE · PrescriptionASPEN PHARMACARE CANADA INCValid
FONDAPARINUX SPC 2.5MG/0.5ML INJECTION5 mg/mlInjection · Subcutaneous use2 Pre-filled syringeSAR 37.20Generic · PrescriptionSUDAIR PHARMA COMPANYValid
ARIXTRA 2.5MG-0.5ML PRE-FILLED SYRINGE5 mg/mlSolution for injection · Subcutaneous use10 Injection SyringeSAR 568.25NCE · PrescriptionGLAXOWELLCOMEWithdrawn by MAH · Not Marketed
ARIXTRA 2.5MG-0.5ML PRE-FILLED SYRINGE5 mg/mlSolution for injection · Subcutaneous use10 Injection SyringeSAR 568.25NCE · PrescriptionASPEN PHARMA TRADING LIMITED (APTL)Withdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

BARIATRIC SURGERY; CARDIOMYOPATHY; CHRONIC LYMPHOCYTIC LEUKEMIA (CLL); DIALYSIS; DIFFUSE LARGE B-CELL LYMPHOMA (DLBCL); FOLLICULAR LYMPHOMA; HIP AND KNEE REPLACEMENT SURGERY; HODGKIN'S LYMPHOMA; 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 EMBOLISM; ST-WAVE ELEVATED MYOCARDIAL INFARCTION (STEMI); T-CELL LYMPHOMA-RENAL TOXICITY; VENOUS THROMBOEMBOLISM DISEASE (VTE)-TREATMENT

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

ProductStrengthForm · routeApplicantStatusFirst approved
ARIXTRA2.5MG/0.5ML (2.5MG/0.5ML); 5MG/0.4ML (5MG/0.4ML); 7.5MG/0.6ML (7.5MG/0.6ML); 10MG/0.8ML (10MG/0.8ML)solution · subcutaneousMYLAN IRELAND LTDPrescription7 Dec 2001
FONDAPARINUX SODIUM2.5MG/0.5ML (2.5MG/0.5ML); 5MG/0.4ML (5MG/0.4ML); 7.5MG/0.6ML (7.5MG/0.6ML); 10MG/0.8ML (10MG/0.8ML)solution · subcutaneousDR REDDYS LABS LTDPrescription11 Jul 2011
FONDAPARINUX SODIUM2.5MG/0.5ML (2.5MG/0.5ML); 5MG/0.4ML (5MG/0.4ML); 7.5MG/0.6ML (7.5MG/0.6ML); 10MG/0.8ML (10MG/0.8ML)solution · subcutaneousEUGIA PHARMAPrescription26 Dec 2017
FONDAPARINUX SODIUM2.5MG/0.5ML (2.5MG/0.5ML); 5MG/0.4ML (5MG/0.4ML); 7.5MG/0.6ML (7.5MG/0.6ML); 10MG/0.8ML (10MG/0.8ML)solution · subcutaneousSCINOPHARM TAIWANPrescription14 Nov 2018
FONDAPARINUX SODIUM2.5MG/0.5ML (2.5MG/0.5ML); 5MG/0.4ML (5MG/0.4ML); 7.5MG/0.6ML (7.5MG/0.6ML); 10MG/0.8ML (10MG/0.8ML)solution · subcutaneousHENGRUI PHARMADiscontinued15 May 2018
FONDAPARINUX SODIUM2.5MG/0.5ML (2.5MG/0.5ML); 5MG/0.4ML (5MG/0.4ML); 7.5MG/0.6ML (7.5MG/0.6ML); 10MG/0.8ML (10MG/0.8ML)solution · subcutaneousHANGZHOU ZHONGMEIDiscontinued19 Aug 2024
FONDAPARINUX SODIUM2.5MG/0.5ML (2.5MG/0.5ML)solution · subcutaneousBRIGHTGENEDiscontinued18 Dec 2024

EMA European Union — centrally authorised medicines

Arixtra Viatris Healthcare Limited · Authorised · authorised 20 Mar 2002 · ATC B01AX05

Therapeutic indication (EMA)

1.5-mg/0.3-ml and 2.5-mg/0.5-ml solution for injection Prevention of venous thromboembolic events (VTE) in adults undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip-replacement surgery. Prevention of VTE in adults undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery. Prevention of VTE in adult medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and / or acute respiratory disorders, and / or acute infectious or inflammatory disease. Treatment of adults with acute symptomatic spontaneous superficial-vein thrombosis of the lower limbs without concomitant deep-vein thrombosis. 2.5-mg/0.5-ml solution for injection Treatment of unstable angina or non-ST-segment-elevation myocardial infarction (UA/NSTEMI) in adult patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated. infarction (STEMI) in adult patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy. 5-mg/0.4-ml, 7.5-mg/0.6-ml and 10-mg/0.8-ml solution for injection Treatment of adults with acute deep-vein thrombosis (DVT) and treatment of acute pulmonary embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

Quixidar Glaxo Group Ltd. · Withdrawn · authorised 21 Mar 2002 · ATC B01AX05

Therapeutic indication (EMA)

1.5 mg/0.3 ml and 2.5 mg/0.5 ml, solution for injection: Prevention of Venous Thromboembolic Events (VTE) in patients undergoing major orthopaedic surgery of the lower limbs such as hip fracture, major knee surgery or hip replacement surgery. Prevention of Venous Thromboembolic Events (VTE) in patients undergoing abdominal surgery who are judged to be at high risk of thromboembolic complications, such as patients undergoing abdominal cancer surgery (see section 5.1). Prevention of Venous Thromboembolic Events (VTE) in medical patients who are judged to be at high risk for VTE and who are immobilised due to acute illness such as cardiac insufficiency and/or acute respiratory disorders, and/or acute infectious or inflammatory disease. 2.5 mg/0.5 ml, solution for injection: Treatment of unstable angina or non-ST segment elevation myocardial infarction (UA/NSTEMI) in patients for whom urgent (< 120 mins) invasive management (PCI) is not indicated (see sections 4.4 and 5.1). Treatment of ST segment elevation myocardial infarction (STEMI) in patients who are managed with thrombolytics or who initially are to receive no other form of reperfusion therapy. 5 mg/0.4 ml, 7.5 mg/0.6 ml and 10 mg/0.8 ml solution for injection: Treatment of acute Deep Vein Thrombosis (DVT) and treatment of acute Pulmonary Embolism (PE), except in haemodynamically unstable patients or patients who require thrombolysis or pulmonary embolectomy.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ARIXTRA022455312.5 MG / 0.5 MLSOLUTION · INTRAVENOUS; SUBCUTANEOUSASPEN PHARMACARE CANADA INC.
ARIXTRA022580567.5 MG / 0.6 MLSOLUTION · SUBCUTANEOUSASPEN PHARMACARE CANADA INC.
FONDAPARINUX SODIUM INJECTION024068532.5 MG / 0.5 MLSOLUTION · INTRAVENOUS; SUBCUTANEOUSDR REDDY'S LABORATORIES LTD
FONDAPARINUX SODIUM INJECTION024068967.5 MG / 0.6 MLSOLUTION · SUBCUTANEOUSDR REDDY'S LABORATORIES LTD

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFONDAPARINUX 10 MG/0.8 ML SYR$44.81613per ML23 Sep 2026
US NADACFONDAPARINUX 2.5 MG/0.5 ML SYR$22.16233per ML19 Aug 2026
US NADACFONDAPARINUX 2.5 MG/0.5 ML SYR$12.12467per ML23 Sep 2026
US NADACFONDAPARINUX 7.5 MG/0.6 ML SYR$42.80893per ML23 Sep 2026
NHS Drug TariffFondaparinux sodium 10mg/0.8ml solution for injection pre-filled syringes£116.5310 pre-filled disposable injection1 Oct 2026
NHS Drug TariffFondaparinux sodium 2.5mg/0.5ml solution for injection pre-filled syringes£62.7910 pre-filled disposable injection1 Oct 2026
NHS Drug TariffFondaparinux sodium 5mg/0.4ml solution for injection pre-filled syringes£116.5310 pre-filled disposable injection1 Oct 2026
NHS Drug TariffFondaparinux sodium 7.5mg/0.6ml solution for injection pre-filled syringes£116.5310 pre-filled disposable injection1 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 fondaparinux →

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.