Regulatory PathRegulatory requirements compared

Active substance

Apomorphine

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Dacepton5 mg/mlSolution for infusion · Subcutaneous use5 VialSAR 890.20NCE · PrescriptionEVER Neuro Pharma GmbHValid
MOVAPO5 mg/mlSolution for infusion in cartridge · Subcutaneous use5 CartridgeSAR 876.95NCE · PrescriptionBritannia Pharmaceuticals LimitedValid
Movapo10 mg/mlSolution for injection · Subcutaneous use5 Pre-filled penSAR 764.55NCE · PrescriptionBritannia Pharmaceuticals LimitedValid
Indications — CHI Daman Drug Formulary

ENDOMETRIOSIS; PARKINSONISM

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

ProductStrengthForm · routeApplicantStatusFirst approved
APOKYN30MG/3ML (10MG/ML)injectable · subcutaneousMDD USPrescription20 Apr 2004
APOMORPHINE HYDROCHLORIDE30MG/3ML (10MG/ML)injectable · subcutaneousTP ANDA HOLDINGSPrescription23 Feb 2022
ONAPGO98MG/20ML (4.9MG/ML)solution · subcutaneousMDD USPrescription3 Feb 2025
APOKYN20MG/2ML (10MG/ML)injectable · subcutaneousMDD USDiscontinued20 Apr 2004
KYNMOBI10MG; 15MG; 20MG; 25MG; 30MGfilm · sublingualSUMITOMO PHARMA AMDiscontinued21 May 2020

EMA European Union — centrally authorised medicines

Uprima Abbott Laboratories Ltd. · Withdrawn · authorised 28 May 2001 · ATC G04BE

Therapeutic indication (EMA)

Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.In order for Uprima to be effective, sexual stimulation is required.

Ixense Takeda Europe R Centre Ltd. · Withdrawn · authorised 28 May 2001 · ATC G04BE

Therapeutic indication (EMA)

Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.In order for Ixense to be effective, sexual stimulation is required.

Taluvian Abbott S.r.l. · Withdrawn · authorised 28 May 2001 · ATC G04BE

Therapeutic indication (EMA)

Treatment of men with erectile dysfunction, which is the inability to achieve or maintain a penile erection sufficient for satisfactory sexual performance.In order for Taluvian to be effective, sexual stimulation is required.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffApomorphine 100mg/20ml solution for infusion vials£145.005 vial1 Oct 2026
NHS Drug TariffApomorphine 30mg/3ml solution for injection cartridges£123.005 cartridge1 Oct 2026
NHS Drug TariffApomorphine 30mg/3ml solution for injection pre-filled disposable devices£123.915 pre-filled disposable injection1 Oct 2026
NHS Drug TariffApomorphine 50mg/10ml solution for infusion pre-filled syringes£73.115 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.

Safety signals and safety-related labeling changes

  • US FDA 22 Sep 2022 KYNMOBI — safety-related labeling change
    Labeling sections changed: Warnings and Precautions; Adverse Reactions; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 22 Jun 2022 APOKYN — 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

All safety entries for apomorphine →

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.