Regulatory PathRegulatory requirements compared

Active substance

Triptorelin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
DECAPEPTYL 0.1MG S.C. Injection*0.1 mgSolution for injection · Subcutaneous use7 Pre-filled syringeSAR 211.45NCE · PrescriptionFERRINGValid
DECAPEPTYL CR 3.75MG SYRINGE3.75 mgPowder and solvent for suspension for injection · Intramuscular use1 Pre-filled syringeSAR 527.05NCE · PrescriptionFERRINGValid
DIPHERELINE 0.1 MG POWDER FOR SOLUTION FOR INJECTION / INFUSION0.1 mgpowder for solution for injection · Subcutaneous use7 VialSAR 122.80NCE · PrescriptionIPSEN PHARMAValid
DIPHERELINE P.R. 11.25 mg Powder for Suspension for Injection11.25 mgPowder and solvent for suspension for injection · Intramuscular use1 VialSAR 1204.00NCE · PrescriptionIPSEN PHARMAValid
DIPHERELINE P.R. 3 mg Powder for Suspension for Injection3 mgPowder and solvent for suspension for injection · Intramuscular use1 VialSAR 458.35NCE · PrescriptionIPSEN PHARMAValid
Diphereline P.R.22.5 mgPowder and solvent for suspension for injection · Intramuscular use1 VialSAR 2350.20NCE · PrescriptionIPSEN PHARMAValid
DECAPEPTYL DEPOT NOVUM 3.75MG VIAL+SOLVT3.75 mgSolution · Intramuscular use1 VialSAR 699.65NCE · PrescriptionFERRINGInvalid · Not Marketed
Indications — CHI Daman Drug Formulary

MENSTRUAL DISORDERS

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

ProductStrengthForm · routeApplicantStatusFirst approved
TRELSTAREQ 3.75MG BASE/VIALinjectable · intramuscularVERITYPrescription15 Jun 2000
TRELSTAREQ 11.25MG BASE/VIALinjectable · intramuscularVERITYPrescription29 Jun 2001
TRELSTAREQ 22.5MG BASE/VIALinjectable · intramuscularVERITYPrescription10 Mar 2010
TRIPTODUR KITEQ 22.5MG BASE/VIALfor suspension, extended release · intramuscularAZURITYPrescription29 Jun 2017

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
DECAPEPTYL023892820.1 MG / MLSOLUTION · SUBCUTANEOUSFERRING INC
TRELSTAR022400003.75 MG / VIALPOWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULARKNIGHT THERAPEUTICS INC.
TRELSTAR0224385611.25 MG / VIALPOWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULARKNIGHT THERAPEUTICS INC.
TRELSTAR0241232222.5 MG / VIALPOWDER FOR SUSPENSION (SUSTAINED-RELEASE · INTRAMUSCULARKNIGHT THERAPEUTICS INC.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffTriptorelin 11.25mg powder and solvent for prolonged-release suspension for injection vials£207.001 vial1 Oct 2026
NHS Drug TariffTriptorelin acetate 3.75mg powder and solvent for prolonged-release suspension for injection pre-filled syringes£81.691 pre-filled disposable injection1 Oct 2026
NHS Drug TariffTriptorelin acetate 3mg powder and solvent for prolonged-release suspension for injection vials£69.001 vial1 Oct 2026
NHS Drug TariffTriptorelin embonate 22.5mg powder and solvent for prolonged-release suspension for injection vials£414.001 vial1 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
    Therapeutic equivalent to leuprorelin for Malignant neoplasms of breast; Therapeutic equivalent to leuprorelin for Malignant neoplasms of prostate

Safety signals and safety-related labeling changes

  • US FDA 26 Jun 2026 TRELSTAR — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 26 Jun 2026 TRELSTAR — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 26 Jun 2026 TRELSTAR — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 23 Sep 2025 TRIPTODUR KIT — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
  • EMA PRAC 29 Sep 2017 PRAC signal: Thromboembolic events
    Action for MAH: update of the product information: No

All safety entries for triptorelin →

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.