Is Epoetin alfa registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 13 valid registrations of Epoetin alfa, including BINOCRIT 1000 I.U/0.5 ml Solution For Injection (1000 IU, Solution for injection in pre-filled syringe, SAR 163.75); BINOCRIT 10000 I.U/1.0 ml Solution For Injection (10000 IU, Solution for injection in pre-filled syringe, SAR 261.00); BINOCRIT 2000 I.U/1.0 ml Solution For Injection (2000 IU, Solution for injection in pre-filled syringe, SAR 329.70); BINOCRIT 30000 I.U/0.75 ml Solution For Injection (30000 IU, Solution for injection in pre-filled syringe, SAR 783.00); BINOCRIT 4000 I.U/0.4 ml Solution For Injection (4000 IU, Solution for injection in pre-filled syringe, SAR 659.40).

Is Epoetin alfa approved by the US FDA?

Drugs@FDA lists 2 application product lines for Epoetin alfa, including EPOGEN/PROCRIT (Prescription); EPOGEN/PROCRIT (Prescription).

Is Epoetin alfa authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Epoetin alfa: Epoetin Alfa Hexal, Abseamed, Binocrit.

Is Epoetin alfa on the WHO Model List of Essential Medicines?

Yes — 10.1. Antianaemia medicines (complementary list): Therapeutic equivalent to erythropoiesis-stimulating agents for Anaemia due to chronic disease.

Are there safety signals or safety updates for Epoetin alfa?

EMA PRAC: 2 entries; US FDA: 1 entry (latest 2018-07-25).

Active substance

Epoetin alfa

SFDA 20
US FDA 2
EMA 4
Health Canada 11
NHS prices 6
WHO EML 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
BINOCRIT 1000 I.U/0.5 ml Solution For Injection	1000 IU	Solution for injection in pre-filled syringe · Intravenous use	6 Pre-filled syringe	SAR 163.75	Biological · Prescription	SANDOZ	Valid
BINOCRIT 10000 I.U/1.0 ml Solution For Injection	10000 IU	Solution for injection in pre-filled syringe · Intravenous use	1 Pre-filled syringe	SAR 261.00	Biological · Prescription	SANDOZ	Valid
BINOCRIT 2000 I.U/1.0 ml Solution For Injection	2000 IU	Solution for injection in pre-filled syringe · Intravenous use	6 Pre-filled syringe	SAR 329.70	Biological · Prescription	SANDOZ	Valid
BINOCRIT 30000 I.U/0.75 ml Solution For Injection	30000 IU	Solution for injection in pre-filled syringe · Intravenous use	1 Pre-filled syringe	SAR 783.00	Biological · Prescription	SANDOZ	Valid
BINOCRIT 4000 I.U/0.4 ml Solution For Injection	4000 IU	Solution for injection in pre-filled syringe · Intravenous use	6 Pre-filled syringe	SAR 659.40	Biological · Prescription	SANDOZ	Valid
BINOCRIT 40000 I.U/1.0 ml Solution For Injection	40000 IU	Solution for injection in pre-filled syringe · Intravenous use	1 Pre-filled syringe	SAR 1044.00	Biological · Prescription	SANDOZ	Valid
EPREX 1000 U-0.5ML PREFILLED SYRING	1000 IU	Solution for injection · Intravenous use	6 Pre-filled syringe	SAR 135.40	Biological · Prescription	Janssen-Cilag International NV	Valid
EPREX 10000 U -ML PREFILLED SYRING	10000 IU	Solution for injection · Intravenous use	6 Pre-filled syringe	SAR 1354.00	Biological · Prescription	Janssen-Cilag International NV	Valid
EPREX 2000 U-0.5ML PREFILLED SYRING	2000 IU	Solution for injection · Intravenous use	6 Pre-filled syringe	SAR 270.80	Biological · Prescription	Janssen-Cilag International NV	Valid
EPREX 40000 IU\ML PRE-FILLED SYRINGE	40000 IU	Solution for injection · Intravenous use	1 Pre-filled syringe	SAR 902.65	Biological · Prescription	Janssen-Cilag International NV	Valid
EPREX 4000IU-0.4ML PROFILLED SYRING	4000 IU	Solution for injection · Intravenous use	6 Pre-filled syringe	SAR 541.60	Biological · Prescription	Janssen-Cilag International NV	Valid
Panpotin	2000 IU	Solution for injection in pre-filled syringe · Intravenous use	6 Pre-filled syringe	SAR 222.60	Biological · Prescription	Saudi Vax	Valid
Panpotin	4000 IU	Solution for injection in pre-filled syringe · Intravenous use	6 Pre-filled syringe	SAR 425.95	Biological · Prescription	Saudi Vax	Valid
BINOCRIT 20000 I.U/0.5 ml Solution For Injection	20000 IU	Solution for injection in pre-filled syringe · Intravenous use	1 Pre-filled syringe	SAR 549.50	Biological · Prescription	SANDOZ	Withdrawn by MAH · Not Marketed
EPREX 3000IU-0.3ML PREFILLED SYRINGE	3000 IU	Solution for injection · Intravenous use	6 Pre-filled syringe	SAR 406.20	Biological · Prescription	Janssen-Cilag International NV	Withdrawn by MAH · Not Marketed
EPREX 40000IU\ML	40000 IU	Solution for injection · Intravenous use	1 Vial	SAR 1481.75	Biological · Prescription	Janssen-Cilag International NV	Withdrawn by MAH · Not Marketed
EPREX NEW STABILIZER 4000IU-ML VIAL	4000 IU	Solution for injection · Intravenous use	6 Vial	SAR 1183.15	Biological · Prescription	Janssen-Cilag International NV	Withdrawn by MAH · Not Marketed
RECORMON 1000 I.U PREFILLED SYRINGE	1000 IU	Solution for injection · Intravenous use	6 Pre-filled syringe	SAR 416.25	Biological · Prescription	ROCHE DIAGNOSTICS	Withdrawn by MAH · Not Marketed
RECORMON 1000 I.U+1ML WARET FOR INJ VIAL	1000 IU	Solution for injection · Intravenous use	10 Vial	SAR 733.20	Biological · Prescription	ROCHE DIAGNOSTICS	Withdrawn by MAH · Not Marketed
RECORMON 2000 I.U-ML VIAL	2000 IU	Solution for injection · Intravenous use	10 Vial	SAR 1158.80	Biological · Prescription	SPIMACO ADDWAEIH	Withdrawn by MAH · Not Marketed

Indications — CHI Daman Drug Formulary

ADULT ACUTE MYELOID LEUKAEMIA (AML); ANEMIA IN CHRONIC KIDNEY DISEASE; IRON DEFICIENCY ANEMIA, CHRONIC KIDNEY DISEASE ASSOCIATED ANEMIA; MYELODYSPLASTIC SYNDROMES- ANEMIA; MYELOFIBROSIS-SYMPTOMATIC, LOW-RISK

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

Product	Strength	Form · route	Applicant	Status	First approved
EPOGEN/PROCRIT	10,000U/ML; 2,000U/ML; 3,000U/ML; 40,000U/ML; 4,000U/ML	vial · single-use	AMGEN	Prescription	1 Jun 1989
EPOGEN/PROCRIT	20,000U/2ML; 20,000/ML	vial · multidose	AMGEN	Prescription	1 Jun 1989

EMA European Union — centrally authorised medicines

Epoetin Alfa Hexal Hexal AG · Authorised · authorised 27 Aug 2007 · ATC B03XA01

Therapeutic indication (EMA)

Abseamed Medice Arzneimittel Pütter GmbH Co. KG · Authorised · authorised 27 Aug 2007 · ATC B03XA01

Therapeutic indication (EMA)

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients: treatment of anaemia associated with chronic renal failure in paediatric and adult patients on haemodialysis and adult patients on peritoneal dialysis; treatment of severe anaemia of renal origin accompanied by clinical symptoms in adult patients with renal insufficiency not yet undergoing dialysis. Treatment of anaemia and reduction of transfusion requirements in adult patients receiving chemotherapy for solid tumours, malignant lymphoma or multiple myeloma, and at risk of transfusion as assessed by the patient's general status (e.g. cardiovascular status, pre existing anaemia at the start of chemotherapy). Abseamed can be used to increase the yield of autologous blood from patients in a predonation programme. Its use in this indication must be balanced against the reported risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (haemoglobin (Hb) 10-13 g/dl [6.2-8.1 mmol/l], no iron deficiency), if blood saving procedures are not available or insufficient when the scheduled major elective surgery requires a large volume of blood (4 or more units of blood for females or 5 or more units for males). Abseamed can be used to reduce exposure to allogeneic blood transfusions in adult non iron deficient patients prior to major elective orthopaedic surgery, having a high perceived risk for transfusion complications. Use should be restricted to patients with moderate anaemia (e.g. Hb 10-13 g/dl) who do not have an autologous predonation programme available and with an expected blood loss of 900 to 1800 ml.

Binocrit Sandoz GmbH · Authorised · authorised 28 Aug 2007 · ATC B03XA01

Therapeutic indication (EMA)

Epostim Reliance GeneMedix Plc · Application withdrawn

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
EPREX STERILE SOLUTION	02243239	20000 UNIT / 0.5 ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	JANSSEN INC
EPREX STERILE SOLUTION	02288680	30000 UNIT / 0.75 ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	JANSSEN INC
EPREX STERILE SOLUTION 10000IU/1.0ML	02231587	10000 UNIT / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	JANSSEN INC
EPREX STERILE SOLUTION 1000IU/0.5ML	02231583	1000 UNIT / 0.5 ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	JANSSEN INC
EPREX STERILE SOLUTION 2000IU/0.5ML	02231584	2000 UNIT / 0.5 ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	JANSSEN INC
EPREX STERILE SOLUTION 3000IU/0.3ML	02231585	3000 UNIT / 0.3 ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	JANSSEN INC
EPREX STERILE SOLUTION 40000IU/ML	02240722	40000 UNIT / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	JANSSEN INC
EPREX STERILE SOLUTION 4000IU/0.4ML	02231586	4000 UNIT / 0.4 ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	JANSSEN INC
EPREX STERILE SOLUTION 5000IU/0.5ML	02243400	5000 UNIT / 0.5 ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	JANSSEN INC
EPREX STERILE SOLUTION 6000 IU/0.6 ML	02243401	6000 UNIT / 0.6 ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	JANSSEN INC
EPREX STERILE SOLUTION 8000 IU/0.8 ML	02243403	8000 UNIT / 0.8 ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	JANSSEN INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Epoetin alfa 10,000units/1ml solution for injection pre-filled syringes	£331.85	6 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Epoetin alfa 2,000units/0.5ml solution for injection pre-filled syringes	£66.37	6 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Epoetin alfa 20,000units/0.5ml solution for injection pre-filled syringes	£110.62	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Epoetin alfa 4,000units/0.4ml solution for injection pre-filled syringes	£132.74	6 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Epoetin alfa 40,000units/1ml solution for injection pre-filled syringes	£265.48	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Epoetin alfa 6,000units/0.6ml solution for injection pre-filled syringes	£199.11	6 pre-filled disposable injection	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)

10.1. Antianaemia medicines · complementary
Therapeutic equivalent to erythropoiesis-stimulating agents for Anaemia due to chronic disease

Safety signals and safety-related labeling changes

US FDA 25 Jul 2018 EPOGEN/PROCRIT — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 6 Jul 2017 PRAC signal: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
Action for MAH: update of the product information: Yes
EMA PRAC 9 Feb 2017 PRAC signal: Severe cutaneous adverse reactions (SCARs) including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN)
Action for MAH: update of the product information: No

All safety entries for epoetin alfa →

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.