Is Epoetin beta registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 4 valid registrations of Epoetin beta, including RECORMON 2000 I.U PREFILLED SYRINGE (2000 IU, Solution for injection, SAR 811.40); RECORMON PFS 10000IU-0.6ML SOLU. FOR INJ (10000 IU, Solution for injection, SAR 3012.90); RECORMON PFS 30000IU-0.6ML SOLU. FOR INJ (30000 IU, Solution for injection, SAR 7090.25); RECORMON PFS 4000IU-0.3ML SOLU. FOR INJ (4000 IU, Solution for injection, SAR 1205.15).

Is Epoetin beta authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Epoetin beta: NeoRecormon.

Is Epoetin beta 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 beta?

EMA PRAC: 2 entries; MHRA: 1 entry (latest 2017-07-06).

Active substance

Epoetin beta

SFDA 12
EMA 1
NHS prices 8
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
RECORMON 2000 I.U PREFILLED SYRINGE	2000 IU	Solution for injection · Intravenous use	6 Pre-filled syringe	SAR 811.40	Biological · Prescription	ROCHE DIAGNOSTICS	Valid
RECORMON PFS 10000IU-0.6ML SOLU. FOR INJ	10000 IU	Solution for injection · Intravenous use	6 Pre-filled syringe	SAR 3012.90	Biological · Prescription	SPIMACO ADDWAEIH	Valid
RECORMON PFS 30000IU-0.6ML SOLU. FOR INJ	30000 IU	Solution for injection · Intravenous use	4 Pre-filled syringe	SAR 7090.25	Biological · Prescription	SPIMACO ADDWAEIH	Valid
RECORMON PFS 4000IU-0.3ML SOLU. FOR INJ	4000 IU	Solution for injection · Intravenous use	6 Pre-filled syringe	SAR 1205.15	Biological · Prescription	SPIMACO ADDWAEIH	Valid
RECORMON 1000 I.U -ML VIAL	1000 IU	Solution for injection · Intravenous use	10 Vial	SAR 579.85	Biological · Prescription	SPIMACO ADDWAEIH	Invalid · Not Marketed
RECORMON 2000 I.U+1ML WATER FOR INJ VIAL	2000 IU	Solution for injection · Intravenous use	10 Vial	SAR 1465.30	Biological · Prescription	ROCHE DIAGNOSTICS	Invalid · Not Marketed
RECORMON 5000 I.U -ML VIAL	5000 IU	Solution for injection · Intravenous use	5 Vial	SAR 1416.25	Biological · Prescription	SPIMACO ADDWAEIH	Invalid · Not Marketed
RECORMON 5000 I.U PREFILLED SYRINGE	5000 IU	Solution for injection · Intravenous use	6 Pre-filled syringe	SAR 1952.65	Biological · Prescription	ROCHE DIAGNOSTICS	Invalid · Not Marketed
RECORMON 5000 I.U+1ML WATER FOR INJ VIAL	5000 IU	Solution for injection · Intravenous use	5 Vial	SAR 1790.80	Biological · Prescription	ROCHE DIAGNOSTICS	Invalid · Not Marketed
RECORMON PFS 20000IU-0.6ML SOLU. FOR INJ	20000 IU	Solution for injection · Intravenous use	6 Pre-filled syringe	SAR 7090.25	Biological · Prescription	SPIMACO ADDWAEIH	Invalid · Not Marketed
RECORMON PFS 3000IU-0.3ML SOLU. FOR INJ	3000 IU	Solution for injection · Intravenous use	6 Pre-filled syringe	SAR 1063.55	Biological · Prescription	SPIMACO ADDWAEIH	Invalid · Not Marketed
RECORMON PFS 6000IU-0.3ML SOLU. FOR INJ	6000 IU	Solution for injection · Intravenous use	6 Pre-filled syringe	SAR 2127.05	Biological · Prescription	SPIMACO ADDWAEIH	Invalid · Not Marketed

Indications — CHI Daman Drug Formulary

IRON DEFICIENCY ANEMIA, CHRONIC KIDNEY DISEASE ASSOCIATED ANEMIA

EMA European Union — centrally authorised medicines

NeoRecormon Roche Registration GmbH · Authorised · authorised 16 Jul 1997 · ATC B03XA01

Therapeutic indication (EMA)

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adult and paediatric patients; treatment of symptomatic anaemia in adult patients with non-myeloid malignancies receiving chemotherapy; increasing the yield of autologous blood from patients in a pre-donation programme. Its use in this indication must be balanced against the reported increased risk of thromboembolic events. Treatment should only be given to patients with moderate anaemia (Hb 10 - 13 g/dl [6.21 - 8.07 mmol/l], no iron deficiency) if blood conserving 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).

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Epoetin beta 10,000units/0.6ml solution for injection pre-filled syringes	£420.85	6 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Epoetin beta 2,000units/0.3ml solution for injection pre-filled syringes	£84.17	6 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Epoetin beta 3,000units/0.3ml solution for injection pre-filled syringes	£126.25	6 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Epoetin beta 30,000units/0.6ml solution for injection pre-filled syringes	£841.71	4 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Epoetin beta 4,000units/0.3ml solution for injection pre-filled syringes	£168.34	6 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Epoetin beta 5,000units/0.3ml solution for injection pre-filled syringes	£210.42	6 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Epoetin beta 500units/0.3ml solution for injection pre-filled syringes	£21.05	6 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Epoetin beta 6,000units/0.3ml solution for injection pre-filled syringes	£252.50	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

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
MHRA 20 May 2015 Epoetin beta (NeoRecormon): increased risk of retinopathy in preterm infants cannot be excluded
Possible increased risk of retinopathy with epoetin beta in premature infants calls for careful consideration of options for preventing anaemia of prematurity.

All safety entries for epoetin beta →

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.