Is Degarelix registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Degarelix, including FIRMAGON 120 MG POWDER FOR SOLUTION FOR INJECTION (120 mg, Powder and solvent for solution for injection, SAR 1097.80); FIRMAGON 80MG POWDER FOR SOLUTION FOR INJECTION (80 mg, Powder and solvent for solution for injection, SAR 605.45).

Is Degarelix approved by the US FDA?

Drugs@FDA lists 1 application product line for Degarelix, including FIRMAGON (Prescription).

Is Degarelix authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Degarelix: Firmagon, Degarelix Accord.

Are there safety signals or safety updates for Degarelix?

US FDA: 1 entry (latest 2020-02-24).

Active substance

Degarelix

SFDA 2
US FDA 1
EMA 2
Health Canada 2
NHS prices 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
FIRMAGON 120 MG POWDER FOR SOLUTION FOR INJECTION	120 mg	Powder and solvent for solution for injection · Subcutaneous use	2 Vial	SAR 1097.80	NCE · Prescription	FERRING	Valid
FIRMAGON 80MG POWDER FOR SOLUTION FOR INJECTION	80 mg	Powder and solvent for solution for injection · Subcutaneous use	1 Vial	SAR 605.45	NCE · Prescription	FERRING	Valid

Indications — CHI Daman Drug Formulary

PROSTATE CANCER

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

Product	Strength	Form · route	Applicant	Status	First approved
FIRMAGON	EQ 80MG BASE/VIAL; EQ 120MG BASE/VIAL	powder · subcutaneous	FERRING	Prescription	24 Dec 2008

EMA European Union — centrally authorised medicines

Firmagon Ferring Pharmaceuticals A/S · Authorised · authorised 17 Feb 2009 · ATC L02BX02

Therapeutic indication (EMA)

FIRMAGON is a gonadotrophin releasing hormone (GnRH) antagonist indicated: - for treatment of adult male patients with advanced hormone-dependent prostate cancer. - for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. - as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Degarelix Accord Accord Healthcare S.L.U. · Authorised · authorised 29 Sep 2023 · ATC L02BX02

Therapeutic indication (EMA)

Degarelix Accord is a gonadotrophin releasing hormone (GnRH) antagonist indicated: for treatment of adult male patients with advanced hormone-dependent prostate cancer. for treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy. as neo-adjuvant treatment prior to radiotherapy in patients with high-risk localised or locally advanced hormone dependent prostate cancer.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
FIRMAGON	02337029	80 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS	FERRING INC
FIRMAGON	02337037	120 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS	FERRING INC

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
NHS Drug Tariff	Degarelix 80mg powder and solvent for solution for injection vials	£79.90	1 vial	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.

Safety signals and safety-related labeling changes

US FDA 24 Feb 2020 FIRMAGON — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for degarelix →

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.