Is Ganirelix registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 1 valid registration of Ganirelix, including ORGALUTRAN 0.25MG\0.5ML SYRINGE (0.25 mg, Solution for injection, SAR 142.15).

Is Ganirelix approved by the US FDA?

Drugs@FDA lists 8 application product lines for Ganirelix, including GANIRELIX ACETATE (Prescription); FYREMADEL (Prescription); GANIRELIX ACETATE (Prescription); GANIRELIX ACETATE (Prescription); GANIRELIX ACETATE (Prescription).

Is Ganirelix authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Ganirelix: Orgalutran, Ganirelix Gedeon Richter.

Are there safety signals or safety updates for Ganirelix?

US FDA: 1 entry (latest 2024-09-23).

Active substance

Ganirelix

SFDA 2
US FDA 8
EMA 2
Health Canada 1
US price lines 2
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
ORGALUTRAN 0.25MG\0.5ML SYRINGE	0.25 mg	Solution for injection · Subcutaneous use	1 Pre-filled syringe	SAR 142.15	NCE · Prescription	ORGANON	Valid
ORGALUTRAN 0.25MG\0.5ML SYRINGE	0.25 mg	Solution for injection · Subcutaneous use	5 Pre-filled syringe	SAR 710.75	NCE · Prescription	ORGANON	Withdrawn by MAH · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
GANIRELIX ACETATE	250MCG/0.5ML	injectable · injection	ORGANON USA ORGANON	Prescription	29 Jul 1999
FYREMADEL	250MCG/0.5ML	injectable · injection	SUN PHARM	Prescription	30 Nov 2018
GANIRELIX ACETATE	250MCG/0.5ML	injectable · injection	AMPHASTAR PHARMS INC	Prescription	7 Apr 2022
GANIRELIX ACETATE	250MCG/0.5ML	injectable · injection	MEITHEAL	Prescription	6 Jun 2022
GANIRELIX ACETATE	250MCG/0.5ML	injectable · injection	GLAND	Prescription	28 Feb 2023
GANIRELIX ACETATE	250MCG/0.5ML	injectable · injection	LUPIN	Prescription	16 Nov 2023
GANIRELIX ACETATE	250MCG/0.5ML	injectable · injection	QILU	Prescription	23 Apr 2025
GANIRELIX ACETATE	250MCG/0.5ML	injectable · injection	TRIS PHARMA INC	Discontinued	27 Jun 2025

EMA European Union — centrally authorised medicines

Orgalutran Organon N.V. · Authorised · authorised 16 May 2000 · ATC H01CC01

Therapeutic indication (EMA)

The prevention of premature luteinising-hormone surges in women undergoing controlled ovarian hyperstimulation for assisted reproduction techniques. In clinical studies, Orgalutran was used with recombinant human follicle-stimulating hormone or corifollitropin alfa, the sustained follicle stimulant.

Ganirelix Gedeon Richter Chemical Works of Gedeon Richter Plc. (Gedeon Richter Plc.) · Authorised · authorised 15 Jul 2022 · ATC H01CC01

Therapeutic indication (EMA)

Prevention of premature luteinising hormone (LH) surges in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproduction techniques (ART).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ORGALUTRAN	02245641	250 MCG / 0.5 ML	SOLUTION · SUBCUTANEOUS	ORGANON CANADA INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	FYREMADEL 250 MCG/0.5 ML SYR	$62.34667	per ML	17 Dec 2025
US NADAC	GANIRELIX ACET 250 MCG/0.5 ML	$62.34667	per ML	25 Feb 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 23 Sep 2024 GANIRELIX ACETATE — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions

All safety entries for ganirelix →

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.