Is Gonadorelin approved by the US FDA?

Drugs@FDA lists 2 application product lines for Gonadorelin, including FACTREL (Discontinued); LUTREPULSE KIT (Discontinued).

Is Gonadorelin authorised in the United Kingdom?

The MHRA category lists of UK marketing authorisations include 2 products containing Gonadorelin, including GONADORELIN 100 MICROGRAMS POWDER FOR SOLUTION FOR INJECTION; HRF 100MCG (POWDER FOR RECONSTITUTION FOR INJECTION).

Active substance

Gonadorelin

US FDA 2
UK MHRA 2

Open in the medicines table

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

Product	Strength	Form · route	Applicant	Status	First approved
FACTREL	EQ 0.1MG BASE/VIAL; EQ 0.2MG BASE/VIAL; EQ 0.5MG BASE/VIAL	injectable · injection	HIKMA PHARMS	Discontinued	30 Sep 1982
LUTREPULSE KIT	0.8MG/VIAL; 3.2MG/VIAL	injectable · injection	FERRING	Discontinued	10 Oct 1989

UK MHRA United Kingdom — marketing authorisations

Product	Authorisation	Holder	Legal status
GONADORELIN 100 MICROGRAMS POWDER FOR SOLUTION FOR INJECTION	PL 17509/0005	ESTEVE PHARMACEUTICALS LTD	POM
HRF 100MCG (POWDER FOR RECONSTITUTION FOR INJECTION)	PL 17509/0005	ESTEVE PHARMACEUTICALS LTD	POM

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.