Is Cetrorelix 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 Cetrorelix, including CETROTIDE 0.25MG POW. FOR SOLU. FOR INJ. (0.25 mg, Powder and solvent for solution for injection, SAR 156.50); Ovolv (0.25 mg, powder for solution for injection, SAR 109.55).

Is Cetrorelix approved by the US FDA?

Drugs@FDA lists 8 application product lines for Cetrorelix, including CETROTIDE (Prescription); CETRORELIX ACETATE (Prescription); CETRORELIX ACETATE (Prescription); CETRORELIX ACETATE (Prescription); CETRORELIX ACETATE (Prescription).

Is Cetrorelix authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Cetrorelix: Cetrotide.

Are there safety signals or safety updates for Cetrorelix?

US FDA: 1 entry (latest 2023-12-18).

Active substance

Cetrorelix

SFDA 4
US FDA 8
EMA 1
Health Canada 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
CETROTIDE 0.25MG POW. FOR SOLU. FOR INJ.	0.25 mg	Powder and solvent for solution for injection · Intravenous use	1 Vial	SAR 156.50	NCE · Prescription	Merck Europe BV	Valid
Ovolv	0.25 mg	powder for solution for injection · Subcutaneous use	1 Vial	SAR 109.55	Generic · Prescription	Boston Oncology Arabia	Valid
CETROTIDE 0.25MG POW. FOR SOLU. FOR INJ.	0.25 mg	Powder and solvent for solution for injection · Intravenous use	7 Vial	SAR 1047.95	NCE · Prescription	LABORATOIRES SERONO	Withdrawn by MAH · Not Marketed
CETROTIDE 3MG POW. FOR SOLU. FOR INJ.	3 mg	powder for solution for injection · Intravenous use	1 Vial	SAR 938.70	NCE · Prescription	LABORATOIRES SERONO	Invalid · Not Marketed

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

Product	Strength	Form · route	Applicant	Status	First approved
CETROTIDE	EQ 0.25MG BASE/VIAL	powder · subcutaneous	EMD SERONO INC	Prescription	11 Aug 2000
CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	powder · subcutaneous	QILU	Prescription	16 Apr 2024
CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	powder · subcutaneous	LIVZON GRP	Prescription	24 Apr 2024
CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	powder · subcutaneous	GLAND	Prescription	25 Apr 2024
CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	powder · subcutaneous	XIROMED	Prescription	3 Jun 2025
CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	powder · subcutaneous	EPIC PHARMA LLC	Prescription	29 Apr 2026
CETROTIDE	EQ 3MG BASE/VIAL	powder · subcutaneous	EMD SERONO INC	Discontinued	11 Aug 2000
CETRORELIX ACETATE	EQ 0.25MG BASE/VIAL	powder · subcutaneous	TEVA PHARMS INC	Discontinued	12 Aug 2022

EMA European Union — centrally authorised medicines

Cetrotide Merck Europe B.V. · Authorised · authorised 12 Apr 1999 · ATC H01CC02

Therapeutic indication (EMA)

Prevention of premature ovulation in patients undergoing a controlled ovarian stimulation, followed by oocyte-pick-up and assisted-reproductive techniques. In clinical trials, Cetrotide was used with human menopausal gonadotropin (HMG), however, limited experience with recombinant follicule-stimulating hormone (FSH) suggested similar efficacy.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CETROTIDE	02247766	0.25 MG / VIAL	POWDER FOR SOLUTION · SUBCUTANEOUS	EMD SERONO, A DIVISION OF EMD INC., CANADA

Safety signals and safety-related labeling changes

US FDA 18 Dec 2023 CETROTIDE — safety-related labeling change
Labeling sections changed: Adverse Reactions

All safety entries for cetrorelix →

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.