Is Etelcalcetide registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Etelcalcetide, including PARSABIV (10 mg, Solution for injection, SAR 1288.90); PARSABIV (2.5 mg, Solution for injection, SAR 322.20); PARSABIV (5 mg, Solution for injection, SAR 644.45).

Is Etelcalcetide approved by the US FDA?

Drugs@FDA lists 1 application product line for Etelcalcetide, including PARSABIV (Prescription).

Is Etelcalcetide authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Etelcalcetide: Parsabiv.

Are there safety signals or safety updates for Etelcalcetide?

US FDA: 1 entry (latest 2019-03-08).

Active substance

Etelcalcetide

SFDA 3
US FDA 1
EMA 1
Safety 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
PARSABIV	10 mg	Solution for injection · Intravenous use	6 Vial	SAR 1288.90	NCE · Prescription	AMGEN EUROPE B.V.	Valid
PARSABIV	2.5 mg	Solution for injection · Intravenous use	6 Vial	SAR 322.20	NCE · Prescription	AMGEN EUROPE B.V.	Valid
PARSABIV	5 mg	Solution for injection · Intravenous use	6 Vial	SAR 644.45	NCE · Prescription	AMGEN EUROPE B.V.	Valid

Indications — CHI Daman Drug Formulary

HYPERPARATHYRODISM

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

Product	Strength	Form · route	Applicant	Status	First approved
PARSABIV	2.5MG/0.5ML (2.5MG/0.5ML); 5MG/ML (5MG/ML); 10MG/2ML (5MG/ML)	solution · intravenous	KAI PHARMS INC	Prescription	7 Feb 2017

EMA European Union — centrally authorised medicines

Parsabiv Amgen Europe B.V. · Authorised · authorised 11 Nov 2016 · ATC H05BX04

Therapeutic indication (EMA)

Parsabiv is indicated for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with chronic kidney disease (CKD) on haemodialysis therapy.

Safety signals and safety-related labeling changes

US FDA 8 Mar 2019 PARSABIV — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions

All safety entries for etelcalcetide →

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.