Regulatory PathRegulatory requirements compared

Active substance

Choriogonadotropin alfa

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
OVITRELLE 250MCG-0.5ML PRE-FILLED SYRING0.5 mg/mlSolution for injection/infusion · Intramuscular use1 Pre-filled syringeSAR 146.37Biological · PrescriptionSERONOValid
OVITRELLE 250MCG POWDER & SOLVENT FOR INJ250 µgSolution for injection/infusion · Intramuscular use1 VialSAR 142.30Biological · PrescriptionSERONOInvalid · Not Marketed
PREGNYL +SOLVENT1500 IUpowder for solution for injection · Intramuscular use3 AmpouleSAR 41.25Biological · PrescriptionORGANONWithdrawn by MAH · Not Marketed
PREGNYL 5000 IU AMP+SOLVENT5000 IUSolution for injection · Intramuscular use3 AmpouleSAR 142.30Biological · PrescriptionORGANONWithdrawn by MAH · Not Marketed

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

ProductStrengthForm · routeApplicantStatusFirst approved
OVIDRELEQ 0.25MG /0.5MLinjectable · subcutaneousEMD SERONOPrescription20 Sep 2000
OVIDREL0.25MG/VIALinjectable · injectionEMD SERONODiscontinued20 Sep 2000

EMA European Union — centrally authorised medicines

Ovitrelle Merck Europe B.V. · Authorised · authorised 2 Feb 2001 · ATC G03GA08

Therapeutic indication (EMA)

Ovitrelle is indicated in the treatment of: women undergoing superovulation prior to assisted reproductive techniques such as in vitro fertilisation (IVF): Ovitrelle is administered to trigger final follicular maturation and luteinisation after stimulation of follicular growth; anovulatory or oligo-ovulatory women: Ovitrelle is administered to trigger ovulation and luteinisation in anovulatory or oligo-ovulatory patients after stimulation of follicular growth.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
OVIDREL02262088250 MCG / 0.5 MLSOLUTION · SUBCUTANEOUSEMD SERONO, A DIVISION OF EMD INC., CANADA
OVIDREL02371588250 MCG / 0.5 MLSOLUTION · SUBCUTANEOUSEMD SERONO, A DIVISION OF EMD INC., CANADA

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACOVIDREL 250 MCG/0.5 ML SYRG$485.432per ML23 Sep 2026
NHS Drug TariffChoriogonadotropin alfa 250micrograms/0.5ml solution for injection pre-filled syringes£37.661 pre-filled disposable injection1 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.

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.