Regulatory PathRegulatory requirements compared

Active substance

Leuprorelin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
ELIGARD 22.5 MG POWDER FOR SOLUTION FOR INJECTION22.5 mgPowder and solvent for solution for injection · Subcutaneous use1 VialSAR 796.80NCE · PrescriptionASTELLAS PHARMAValid
ELIGARD 45 MG POWDER FOR SOLUTION FOR INJECTION45 mgPowder and solvent for solution for injection · Subcutaneous use1 VialSAR 1750.85NCE · PrescriptionASTELLAS PHARMAValid
ELIGARD 7.5 MG POWDER FOR SOLUTION FOR INJECTION7.5 mgPowder and solvent for solution for injection · Subcutaneous use1 VialSAR 313.90NCE · PrescriptionASTELLAS PHARMAValid
LUPRON DEPOT 3.75MG-VIAL3.75 mgPowder and solvent for suspension for injection · Subcutaneous use1 Pre-filled syringeSAR 423.90NCE · PrescriptionAbbvie BV.Valid
LUPRON DEPOT 7.5MG -VIAL7.5 mgPowder and solvent for suspension for injection · Subcutaneous use1 VialSAR 574.75NCE · PrescriptionABBVIE Inc.Withdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

ENDOMETRIOSIS; PROSTATE CANCER

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

ProductStrengthForm · routeApplicantStatusFirst approved
LUPRON DEPOT7.5MGinjectable · injectionABBVIE ENDOCRINE INCPrescription26 Jan 1989
LUPRON DEPOT3.75MGinjectable · injectionABBVIE ENDOCRINE INCPrescription22 Oct 1990
LUPRON DEPOT-PED KIT7.5MG; 11.25MG; 15MG; 30MG; 45MGpowder · intramuscularABBVIE ENDOCRINE INCPrescription16 Apr 1993
LUPRON DEPOT3.75MGinjectable · injectionABBVIE ENDOCRINE INCPrescription30 Mar 1995
LUPRON DEPOT22.5MG; 30MG; 45MGinjectable · injectionABBVIE ENDOCRINE INCPrescription22 Dec 1995
LUPRON DEPOT11.25MGinjectable · injectionABBVIE ENDOCRINE INCPrescription7 Mar 1997
LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)solution · subcutaneousSANDOZPrescription4 Aug 1998
LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)solution · subcutaneousMEITHEALPrescription25 Oct 2000
ELIGARD KIT7.5MGpowder · subcutaneousTOLMARPrescription23 Jan 2002
ELIGARD KIT22.5MGpowder · subcutaneousTOLMARPrescription24 Jul 2002
ELIGARD KIT30MGpowder · subcutaneousTOLMARPrescription13 Feb 2003
ELIGARD KIT45MGpowder · subcutaneousTOLMARPrescription14 Dec 2004
LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)solution · subcutaneousSUN PHARMPrescription9 Mar 2009
LEUPROLIDE ACETATE FOR DEPOT SUSPENSION22.5MG/VIALfor suspension · intramuscularINVAGEN PHARMSPrescription28 Aug 2018
FENSOLVI KIT45MGpowder · subcutaneousTOLMARPrescription1 May 2020
CAMCEVI KITEQ 42MG BASEemulsion · subcutaneousACCORDPrescription25 May 2021
LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)solution · subcutaneousSOMERSET THERAPS LLCPrescription13 Aug 2021
LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)solution · subcutaneousEUGIA PHARMAPrescription6 Jun 2022
LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)solution · subcutaneousAMNEALPrescription28 Oct 2022
LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)solution · subcutaneousUBIPrescription17 Oct 2024
CAMCEVI ETMEQ 21MG BASEemulsion · subcutaneousACCORDPrescription25 Aug 2025
LEUPROLIDE ACETATE14MG/2.8ML (1MG/0.2ML)solution · subcutaneousZYDUS PHARMSPrescription13 Nov 2025
LUPRON14MG/2.8ML (1MG/0.2ML) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**solution · subcutaneousABBVIE ENDOCRINE INCDiscontinued9 Apr 1985
LUPRON DEPOT3.75MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**injectable · injectionABBVIE ENDOCRINE INCDiscontinued22 Oct 1990
LUPRON DEPOT-PED KIT3.75MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 7.5MG,7.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**powder · intramuscularABBVIE ENDOCRINE INCDiscontinued16 Apr 1993

4 more — full table

EMA European Union — centrally authorised medicines

Camcevi Accord Healthcare S.L.U. · Authorised · authorised 24 May 2022

Therapeutic indication (EMA)

Camcevi is indicated for the treatment of hormone dependent advanced prostate cancer and for the treatment of high-risk localised and locally advanced hormone dependent prostate cancer in combination with radiotherapy.

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
ELIGARD022482397.5 MG / SYRPOWDER FOR SUSPENSION (SUSTAINED-RELEASE · SUBCUTANEOUSTOLMAR INTERNATIONAL LTD.
ELIGARD0224824022.5 MG / SYRPOWDER FOR SUSPENSION (SUSTAINED-RELEASE · SUBCUTANEOUSTOLMAR INTERNATIONAL LTD.
ELIGARD0224899930 MG / SYRPOWDER FOR SUSPENSION (SUSTAINED-RELEASE · SUBCUTANEOUSTOLMAR INTERNATIONAL LTD.
ELIGARD0226889245 MG / SYRPOWDER FOR SUSPENSION (SUSTAINED-RELEASE · SUBCUTANEOUSTOLMAR INTERNATIONAL LTD.
LUPRON DEPOT008362737.5 MG / SYRPOWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULARABBVIE CORPORATION
LUPRON DEPOT008845023.75 MG / SYRPOWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULARABBVIE CORPORATION
LUPRON DEPOT0223024822.5 MG / SYRPOWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULARABBVIE CORPORATION
LUPRON DEPOT0223983330 MG / SYRPOWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULARABBVIE CORPORATION
LUPRON DEPOT0223983411.25 MG / SYRPOWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULARABBVIE CORPORATION
LUPRON DEPOT0256285545 MG / SYRPOWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULARABBVIE CORPORATION
ZEULIDE DEPOT024299773.75 MG / VIALKIT; POWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULARVERITY PHARMACEUTICALS INC.
ZEULIDE DEPOT0246269922.5 MG / VIALPOWDER FOR SUSPENSION (SUSTAINED-RELEASE; KIT · INTRAMUSCULARVERITY PHARMACEUTICALS INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACLEUPROLIDE 2WK 14 MG/2.8 ML KT$197.606per EA3 Jun 2026
US NADACLUPRON DEPOT 11.25 MG 3MO KIT$5437.39667per EA23 Sep 2026
US NADACLUPRON DEPOT 3.75 MG KIT$1822.07714per EA23 Sep 2026
US NADACLUPRON DEPOT 7.5 MG 1 MONTH KT$2174.1678per EA22 Jul 2026
NHS Drug TariffLeuprorelin 1.88mg powder and solvent for prolonged-release suspension for injection pre-filled syringes£60.001 pre-filled disposable injection1 Oct 2026
NHS Drug TariffLeuprorelin 11.25mg implant pre-filled syringes£75.001 pre-filled disposable injection1 Oct 2026
NHS Drug TariffLeuprorelin 11.25mg powder and solvent for prolonged-release suspension for injection pre-filled syringes£225.721 pre-filled disposable injection1 Oct 2026
NHS Drug TariffLeuprorelin 3.75mg powder and solvent for prolonged-release suspension for injection pre-filled syringes£75.241 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.

WHO WHO Model List of Essential Medicines (2025)

  • 8.2.4. Hormones and antihormones · complementary
    Malignant neoplasms of breast; Malignant neoplasms of prostate
    Parenteral > General injections > IM: 7.5 mg in prefilled syringe; 22.5 mg in prefilled syringe

Safety signals and safety-related labeling changes

All safety entries for leuprorelin →

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.