Is Darbepoetin alfa registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 11 valid registrations of Darbepoetin alfa, including ARANESP 100MCG-0.5ML PRE-FILLED SYRINGE (100 µ/ml, Solution for injection, SAR 3096.30); ARANESP 10MCG-0.4ML PRE-FILLED SYRINGE (10 µ/ml, Solution for injection, SAR 373.55); ARANESP 150MCG-0.3ML PRE-FILLED SYRINGE (150 µ/ml, Solution for injection, SAR 5496.60); ARANESP 20MCG-0.5ML PRE-FILLED SYRINGE (20 µ/ml, Solution for injection, SAR 630.55); ARANESP 300MCG-0.6ML PRE-FILLED SYRINGE (300 µ/ml, Solution for injection, SAR 2160.35).

Is Darbepoetin alfa approved by the US FDA?

Drugs@FDA lists 2 application product lines for Darbepoetin alfa, including ARANESP (Prescription); ARANESP (Prescription).

Is Darbepoetin alfa authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Darbepoetin alfa: Aranesp.

Is Darbepoetin 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 Darbepoetin alfa?

EMA PRAC: 4 entries; US FDA: 1 entry (latest 2019-01-30).

Active substance

Darbepoetin alfa

SFDA 12
US FDA 2
EMA 2
Health Canada 13
US price lines 3
NHS prices 18
WHO EML 1
Safety 5

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ARANESP 100MCG-0.5ML PRE-FILLED SYRINGE	100 µ/ml	Solution for injection · Subcutaneous use	4 Pre-filled syringe	SAR 3096.30	Biological · Prescription	AMGEN EUROPE B.V.	Valid
ARANESP 10MCG-0.4ML PRE-FILLED SYRINGE	10 µ/ml	Solution for injection · Subcutaneous use	4 Pre-filled syringe	SAR 373.55	Biological · Prescription	AMGEN EUROPE B.V.	Valid
ARANESP 150MCG-0.3ML PRE-FILLED SYRINGE	150 µ/ml	Solution for injection · Subcutaneous use	4 Pre-filled syringe	SAR 5496.60	Biological · Prescription	AMGEN EUROPE B.V.	Valid
ARANESP 20MCG-0.5ML PRE-FILLED SYRINGE	20 µ/ml	Solution for injection · Subcutaneous use	4 Pre-filled syringe	SAR 630.55	Biological · Prescription	AMGEN EUROPE B.V.	Valid
ARANESP 300MCG-0.6ML PRE-FILLED SYRINGE	300 µ/ml	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 2160.35	Biological · Prescription	AMGEN EUROPE B.V.	Valid
ARANESP 30MCG-0.3ML PRE-FILLED SYRINGE	30 µ/ml	Solution for injection · Subcutaneous use	4 Pre-filled syringe	SAR 936.80	Biological · Prescription	AMGEN EUROPE B.V.	Valid
ARANESP 40MCG-0.4ML PRE-FILLED SYRINGE	40 µ/ml	Solution for injection · Subcutaneous use	4 Pre-filled syringe	SAR 1292.45	Biological · Prescription	AMGEN EUROPE B.V.	Valid
ARANESP 500MCG-1ML PRE-FILLED SYRINGE	500 µ/ml	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 3600.55	Biological · Prescription	AMGEN EUROPE B.V.	Valid
ARANESP 50MCG-0.5ML PRE-FILLED SYRINGE	50 µ/ml	Solution for injection · Subcutaneous use	4 Pre-filled syringe	SAR 1552.95	Biological · Prescription	AMGEN EUROPE B.V.	Valid
ARANESP 60MCG-0.3ML PRE-FILLED SYRINGE	60 µ/ml	Solution for injection · Subcutaneous use	4 Pre-filled syringe	SAR 1909.35	Biological · Prescription	AMGEN EUROPE B.V.	Valid
ARANESP 80MCG-0.4ML PRE-FILLED SYRINGE	80 µ/ml	Solution for injection · Subcutaneous use	4 Pre-filled syringe	SAR 2573.40	Biological · Prescription	AMGEN EUROPE B.V.	Valid
ARANESP 15MCG-0.375ML PRE-FILLED SYRINGE	15 µ/ml	Solution for injection · Subcutaneous use	4 Pre-filled syringe	SAR 719.55	Biological · Prescription	AMGEN EUROPE B.V.	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
ARANESP	25UG/ML; 40UG/ML; 60UG/ML; 100UG/ML; 200UG/ML	vial · intravenous	AMGEN	Prescription	17 Sep 2001
ARANESP	25UG/ML; 40UG/ML; 60UG/ML; 100UG/ML; 200UG/ML	vial · subcutaneous	AMGEN	Prescription	17 Sep 2001

EMA European Union — centrally authorised medicines

Aranesp Amgen Europe B.V. · Authorised · authorised 8 Jun 2001 · ATC B03XA02

Therapeutic indication (EMA)

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients. Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Nespo Dompé Biotec S.p.A. · Withdrawn · authorised 8 Jun 2001 · ATC B03XA02

Therapeutic indication (EMA)

Treatment of symptomatic anaemia associated with chronic renal failure (CRF) in adults and paediatric patients.Treatment of symptomatic anaemia in adult cancer patients with non-myeloid malignancies receiving chemotherapy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ARANESP	02391740	100 MCG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	AMGEN CANADA INC
ARANESP	02391759	100 MCG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	AMGEN CANADA INC
ARANESP	02391767	200 MCG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	AMGEN CANADA INC
ARANESP	02391775	200 MCG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	AMGEN CANADA INC
ARANESP	02391783	200 MCG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	AMGEN CANADA INC
ARANESP	02391791	500 MCG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	AMGEN CANADA INC
ARANESP	02391805	500 MCG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	AMGEN CANADA INC
ARANESP	02391821	500 MCG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	AMGEN CANADA INC
ARANESP	02392313	25 MCG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	AMGEN CANADA INC
ARANESP	02392321	40 MCG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	AMGEN CANADA INC
ARANESP	02392348	100 MCG / ML	SOLUTION · INTRAVENOUS; SUBCUTANEOUS	AMGEN CANADA INC
ARANESP	02392356	200 MCG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	AMGEN CANADA INC
ARANESP	02392364	500 MCG / ML	SOLUTION · SUBCUTANEOUS; INTRAVENOUS	AMGEN CANADA INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ARANESP 25 MCG/0.42 ML SYRING	$446.57738	per ML	23 Sep 2026
US NADAC	ARANESP 40 MCG/0.4 ML SYRINGE	$752.43625	per ML	20 May 2026
US NADAC	ARANESP 60 MCG/0.3 ML SYRINGE	$1500.14688	per ML	23 Sep 2026
NHS Drug Tariff	Darbepoetin alfa 100micrograms/0.5ml solution for injection pre-filled disposable devices	£146.81	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Darbepoetin alfa 100micrograms/0.5ml solution for injection pre-filled syringes	£587.24	4 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Darbepoetin alfa 10micrograms/0.4ml solution for injection pre-filled syringes	£58.72	4 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Darbepoetin alfa 150micrograms/0.3ml solution for injection pre-filled disposable devices	£220.22	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Darbepoetin alfa 150micrograms/0.3ml solution for injection pre-filled syringes	£880.86	4 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Darbepoetin alfa 20micrograms/0.5ml solution for injection pre-filled disposable devices	£29.36	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Darbepoetin alfa 20micrograms/0.5ml solution for injection pre-filled syringes	£117.45	4 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Darbepoetin alfa 300micrograms/0.6ml solution for injection pre-filled disposable devices	£440.43	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Darbepoetin alfa 300micrograms/0.6ml solution for injection pre-filled syringes	£440.43	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Darbepoetin alfa 30micrograms/0.3ml solution for injection pre-filled syringes	£176.17	4 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Darbepoetin alfa 40micrograms/0.4ml solution for injection pre-filled disposable devices	£58.72	1 pre-filled disposable injection	1 Oct 2026
NHS Drug Tariff	Darbepoetin alfa 40micrograms/0.4ml solution for injection pre-filled syringes	£234.90	4 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 30 Jan 2019 ARANESP — safety-related labeling change
Labeling sections changed: 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
EMA PRAC 12 Jan 2017 PRAC signal: Incorrect use of device associated with adverse reactions including underdose, drug dose omission, accidental exposure to product and injection site reactions
Action for MAH: update of the product information: Yes
EMA PRAC 2 Sep 2016 PRAC signal: Incorrect use of device associated with adverse reactions including underdose, drug dose omission, accidental exposure to product and injection site reactions
Action for MAH: update of the product information: No

All safety entries for darbepoetin 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.