Regulatory PathRegulatory requirements compared

Active substance

Lutropin alfa

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
LUVERIS 75 I.U. POWDER FOR SOLU. FOR INJ75 IUPowder and solvent for solution for injection · Intravenous use3 VialSAR 302.55Biological · PrescriptionSERONOValid
LUVERIS 75 I.U. POWDER FOR SOLU. FOR INJ75 IUPowder and solvent for solution for injection · Subcutaneous use10 VialSAR 1397.10Biological · PrescriptionSERONOWithdrawn by MAH · Not Marketed
LUVERIS 75 I.U. POWDER FOR SOLU. FOR INJ75 IUPowder and solvent for solution for injection · Intravenous use1 VialSAR 146.05Biological · PrescriptionSERONOWithdrawn by MAH · Not Marketed

EMA European Union — centrally authorised medicines

Luveris Merck Europe B.V. · Authorised · authorised 29 Nov 2000 · ATC G03GA07

Therapeutic indication (EMA)

Luveris in association with a follicle-stimulating-hormone (FSH) preparation is recommended for the stimulation of follicular development in women with severe luteinising-hormone (LH) and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH level <1.2 IU/l.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
LUVERIS0226906675 UNIT / VIALPOWDER FOR SOLUTION · SUBCUTANEOUSEMD SERONO, A DIVISION OF EMD INC., CANADA

Combinations containing Lutropin alfa

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.