Is Apixaban registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 37 valid registrations of Apixaban, including ATIQUIX (5 mg, Film-coated tablet, SAR 231.00); ATIQUIX (2.5 mg, Film-coated tablet, SAR 231.00); Apdx (5 mg, Film-coated tablet, SAR 115.50); Apdx (2.5 mg, Film-coated tablet, SAR 115.50); Apixaban BOS (2.5 mg, Film-coated tablet, SAR 80.85).

Is Apixaban approved by the US FDA?

Drugs@FDA lists 20 application product lines for Apixaban, including ELIQUIS (Prescription); ELIQUIS (Prescription); APIXABAN (Prescription); APIXABAN (Prescription); ELIQUIS SPRINKLE (Prescription).

Is Apixaban authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Apixaban: Eliquis, Apixaban Accord.

Is Apixaban on the WHO Model List of Essential Medicines?

Yes — 10.2. Medicines affecting coagulation (core list): Therapeutic equivalent to dabigatran for Other specified atrial fibrillation; Therapeutic equivalent to dabigatran for Venous thromboembolism.

Are there safety signals or safety updates for Apixaban?

EMA PRAC: 14 entries; US FDA: 1 entry (latest 2025-04-17).

Active substance

Apixaban

SFDA 37
US FDA 20
EMA 2
Health Canada 43
US price lines 2
NHS prices 2
WHO EML 1
Safety 15

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ATIQUIX	5 mg	Film-coated tablet · Oral use	60 Blister	SAR 231.00	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
ATIQUIX	2.5 mg	Film-coated tablet · Oral use	60 Blister	SAR 231.00	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Apdx	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 115.50	Generic · Prescription	Med City Pharma	Valid
Apdx	2.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 115.50	Generic · Prescription	Med City Pharma	Valid
Apdx	2.5 mg	Film-coated tablet · Oral use	60 Blister	SAR 231.00	Generic · Prescription	Med City Pharma	Valid
Apdx	5 mg	Film-coated tablet · Oral use	60 Blister	SAR 231.00	Generic · Prescription	Med City Pharma	Valid
Apixaban BOS	2.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 80.85	Generic · Prescription	Boston Oncology Arabia	Valid
Apixaban BOS	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 80.85	Generic · Prescription	Boston Oncology Arabia	Valid
Apixaban JPI	5 mg	Film-coated tablet · Oral use	60 Blister	SAR 231.00	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Apixaban JPI	2.5 mg	Film-coated tablet · Oral use	60 Blister	SAR 231.00	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
Apixaban JPI	2.5 mg	Film-coated tablet · Oral use	20 Blister	SAR 77.00	Generic · Prescription	Jazeera Pharmaceutical Industries (JPI)	Valid
ELIQUIS 2.5MG FILM COATED TABLET	2.5 mg	Film-coated tablet · Oral use	20 Blister	SAR 97.55	NCE · Prescription	Bristol-Myers Squibb / Pharma EEIG	Valid
ELIQUIS 2.5MG FILM COATED TABLET	2.5 mg	Film-coated tablet · Oral use	60 Blister	SAR 292.60	NCE · Prescription	Bristol-Myers Squibb / Pharma EEIG	Valid
ELIQUIS 5MG FILM COATED TABLET	5 mg	Film-coated tablet · Oral use	60 Blister	SAR 292.60	NCE · Prescription	Bristol-Myers Squibb / Pharma EEIG	Valid
Experta	2.5 mg	Film-coated tablet · Oral use	60 Blister	SAR 231.00	Generic · Prescription	Saudi Pharmaceutical Industries & Medical Appliances Corporation	Valid
Experta	5 mg	Film-coated tablet · Oral use	60 Blister	SAR 231.00	Generic · Prescription	Saudi Pharmaceutical Industries & Medical Appliances Corporation	Valid
Iksaront	5 mg	Film-coated tablet · Oral use	30 Blister	SAR 115.50	Generic · Prescription	Apex Pharma	Valid
Iksaront	2.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 115.50	Generic · Prescription	Apex Pharma	Valid
PAQUIX 2.5MG FILM COATED TABLET	2.5 mg	Film-coated tablet · Oral use	30 Blister	SAR 118.20	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
PAQUIX 2.5MG FILM COATED TABLET	2.5 mg	Film-coated tablet · Oral use	60 Blister	SAR 224.15	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
PAQUIX 5 MG FILM COATED TABLET	5 mg	Film-coated tablet · Oral use	60 Blister	SAR 224.15	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Paxas	5 mg	Film-coated tablet · Oral use	60 Blister	SAR 231.00	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Paxas	2.5 mg	Film-coated tablet · Oral use	60 Blister	SAR 231.00	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Paxas	2.5 mg	Film-coated tablet · Oral use	20 Blister	SAR 77.00	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
Pexapan	5 mg	Film-coated tablet · Oral use	60 Blister	SAR 231.00	Generic · Prescription	Jamjoom Pharmaceuticals Factory Company	Valid

12 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; POLYCYTHEMIA VERA - THROMBOSIS; PORTAL VEIN THROMBOSIS; PULMONARY ARTERIAL HYPERTENSION; PULMONARY EMBOLISM; T-CELL LYMPHOMA-RENAL TOXICITY; VENOUS THROMBOEMBOLISM DISEASE (VTE)-TREATMENT

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

Product	Strength	Form · route	Applicant	Status	First approved
ELIQUIS	2.5MG; 5MG	tablet · oral	BRISTOL MYERS SQUIBB	Prescription	28 Dec 2012
ELIQUIS	0.5MG	tablet, for suspension · oral	BRISTOL MYERS SQUIBB	Prescription	28 Dec 2012
APIXABAN	2.5MG; 5MG	tablet · oral	ACCORD HLTHCARE	Prescription	28 Jul 2020
APIXABAN	2.5MG; 5MG	tablet · oral	REGCON HOLDINGS	Prescription	11 Sep 2020
ELIQUIS SPRINKLE	0.15MG	for suspension · oral	BRISTOL	Prescription	17 Apr 2025
ELIQUIS	5MG; 0.5MG	tablet · oral	BRISTOL	Prescription	17 Apr 2025
ELIQUIS	0.15MG	suspension · oral	BRISTOL	Prescription	17 Apr 2025
APIXABAN	2.5MG; 5MG	tablet · oral	SUN PHARM INDUSTRIES	Prescription
APIXABAN	1.25MG/ML	suspension · oral	LUPIN	Prescription
APIXABAN	2.5MG; 5MG	tablet · oral	MICRO LABS	Discontinued	23 Dec 2019
APIXABAN	2.5MG; 5MG	tablet · oral	MYLAN	Discontinued	23 Dec 2019
APIXABAN	2.5MG; 5MG	tablet · oral	BIONPHARMA	Discontinued	8 Apr 2020
APIXABAN	2.5MG; 5MG	tablet · oral	BRECKENRIDGE	Discontinued	26 Jul 2021
APIXABAN	2.5MG; 5MG	tablet · oral	ZYDUS PHARMS	Discontinued	27 Feb 2023
APIXABAN	2.5MG; 5MG	tablet · oral	AUROBINDO PHARMA LTD	Discontinued	26 May 2023
APIXABAN	2.5MG; 5MG	tablet · oral	HETERO LABS LTD V	Discontinued	21 Nov 2023
APIXABAN	2.5MG; 5MG	tablet · oral	APOTEX	Discontinued	16 Feb 2024
APIXABAN	2.5MG; 5MG	tablet · oral	TORRENT	Discontinued	17 Dec 2024
APIXABAN	2.5MG; 5MG	tablet · oral	IMPAX	Discontinued	14 Feb 2025
APIXABAN	2.5MG; 5MG	tablet · oral	MACLEODS PHARMS	Discontinued	27 Feb 2025

EMA European Union — centrally authorised medicines

Eliquis Bristol-Myers Squibb / Pfizer EEIG · Authorised · authorised 18 May 2011 · ATC B01AF02

Therapeutic indication (EMA)

Treatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).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 recurrent VTE in paediatric patients from 28 days to less than 18 years of age. AdultsPrevention of stroke and systemic embolism in adult patients with non valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II).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 populationTreatment of venous thromboembolism (VTE) and prevention of recurrent VTE in paediatric patients from 28 days to less than 18 years of age.

Apixaban Accord Accord Healthcare S.L.U. · Authorised · authorised 23 Jul 2020 · ATC B01AF02

Therapeutic indication (EMA)

Adults Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). 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 recurrent VTE in paediatric patients from 28 days to less than 18 years of age. Adults Prevention of venous thromboembolic events (VTE) in adult patients who have undergone elective hip or knee replacement surgery. Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischaemic attack (TIA); age ≥ 75 years; hypertension; diabetes mellitus; symptomatic heart failure (NYHA Class ≥ II). 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 recurrent VTE in paediatric patients from 28 days to less than 18 years of age.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ACH-APIXABAN	02487713	2.5 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
ACH-APIXABAN	02487721	5 MG	TABLET · ORAL	ACCORD HEALTHCARE INC
AG-APIXABAN	02529912	2.5 MG	TABLET · ORAL	ANGITA PHARMA INC.
AG-APIXABAN	02529920	5 MG	TABLET · ORAL	ANGITA PHARMA INC.
APIXABAN	02530708	2.5 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
APIXABAN	02530716	5 MG	TABLET · ORAL	SIVEM PHARMACEUTICALS ULC
APIXABAN	02548879	2.5 MG	TABLET · ORAL	SANIS HEALTH INC
APIXABAN	02548887	5 MG	TABLET · ORAL	SANIS HEALTH INC
APO-APIXABAN	02487381	2.5 MG	TABLET · ORAL	APOTEX INC
APO-APIXABAN	02487403	5 MG	TABLET · ORAL	APOTEX INC
AURO-APIXABAN	02486806	2.5 MG	TABLET · ORAL	AURO PHARMA INC
AURO-APIXABAN	02486814	5 MG	TABLET · ORAL	AURO PHARMA INC
BIO-APIXABAN	02527979	2.5 MG	TABLET · ORAL	BIOMED PHARMA
BIO-APIXABAN	02527987	5 MG	TABLET · ORAL	BIOMED PHARMA
ELIQUIS	02377233	2.5 MG	TABLET · ORAL	BRISTOL-MYERS SQUIBB CANADA
ELIQUIS	02397714	5 MG	TABLET · ORAL	BRISTOL-MYERS SQUIBB CANADA
JAMP APIXABAN	02528924	2.5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP APIXABAN	02528932	5 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
M-APIXABAN	02529009	2.5 MG	TABLET · ORAL	MANTRA PHARMA INC
M-APIXABAN	02529017	5 MG	TABLET · ORAL	MANTRA PHARMA INC
MAR-APIXABAN	02492369	2.5 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MAR-APIXABAN	02492377	5 MG	TABLET · ORAL	MARCAN PHARMACEUTICALS INC
MINT-APIXABAN	02495430	2.5 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
MINT-APIXABAN	02495449	5 MG	TABLET · ORAL	MINT PHARMACEUTICALS INC
NAT-APIXABAN	02492814	2.5 MG	TABLET · ORAL	NATCO PHARMA (CANADA) INC

18 more — full table

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ELIQUIS 2.5 MG TABLET	$5.51282	per EA	23 Sep 2026
US NADAC	ELIQUIS 5 MG TABLET	$5.52114	per EA	23 Sep 2026
NHS Drug Tariff	Apixaban 2.5mg tablets	£1.82	60 tablet	1 Oct 2026
NHS Drug Tariff	Apixaban 5mg tablets	£2.08	56 tablet	1 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

US FDA 17 Apr 2025 ELIQUIS — 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
EMA PRAC 5 May 2022 PRAC signal: Masking of acquired haemophilia
Action for MAH: update of the product information: No
EMA PRAC 12 Mar 2020 PRAC signal: Erythema multiforme
Action for MAH: update of the product information: No
EMA PRAC 11 Apr 2019 PRAC signal: Recurrent thrombosis in patients with antiphospholipid syndrome
Action for MAH: update of the product information: Yes
EMA PRAC 15 Mar 2019 PRAC signal: Pancreatitis
Action for MAH: update of the product information: No
EMA PRAC 17 Jan 2019 PRAC signal: Pancreatitis
Action for MAH: update of the product information: No
EMA PRAC 31 Oct 2018 PRAC signal: Recurrent thrombosis in patients with antiphospholipid syndrome
Action for MAH: update of the product information: No
EMA PRAC 6 Sep 2018 PRAC signal: Pancreatitis
Action for MAH: update of the product information: No
EMA PRAC 17 May 2018 PRAC signal: Neutropenia
Action for MAH: update of the product information: No
EMA PRAC 17 May 2018 PRAC signal: Tubulointerstitial nephritis
Action for MAH: update of the product information: No
EMA PRAC 17 May 2018 PRAC signal: Drug interaction between apixaban or edoxaban and selective serotonin reuptake inhibitors and/or serotonin reuptake inhibitors leading to increased risk of bleeding
Action for MAH: update of the product information: Yes
EMA PRAC 8 Feb 2018 PRAC signal: Cholesterol embolisms
Action for MAH: update of the product information: No
EMA PRAC 11 Jan 2018 PRAC signal: Tubulointerstitial nephritis
Action for MAH: update of the product information: No
EMA PRAC 11 Jan 2018 PRAC signal: Drug interaction between apixaban or edoxaban and selective serotonin reuptake inhibitors and/or serotonin reuptake inhibitors leading to increased risk of bleeding
Action for MAH: update of the product information: No
EMA PRAC 29 Sep 2017 PRAC signal: Cholesterol embolisms
Action for MAH: update of the product information: No

All safety entries for apixaban →

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.