Regulatory PathRegulatory requirements compared

Active substance

Avanafil

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
SPEDRA 100 mg Tablet100 mgTablet · Oral use4 BlisterSAR 59.00NCE · PrescriptionSANOFI WINTHROP INDUSTRIEValid
SPEDRA 200 mg Tablet200 mgTablet · Oral use4 BlisterSAR 59.00NCE · PrescriptionSANOFI WINTHROP INDUSTRIEValid
SPEDRA 50 mg Tablet50 mgTablet · Oral use4 BlisterSAR 54.50NCE · PrescriptionSANOFI WINTHROP INDUSTRIEValid
Vantra100 mgTablet · Oral use4 BlisterSAR 55.05Generic · PrescriptionSPIMACO ADDWAEIHValid
Vantra200 mgTablet · Oral use4 BlisterSAR 55.05Generic · PrescriptionSPIMACO ADDWAEIHValid
Vantra50 mgTablet · Oral use4 BlisterSAR 44.25Generic · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
Vantra50 mgTablet · Oral use12 BlisterSAR 132.75Generic · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
Vantra50 mgTablet · Oral use30 BlisterSAR 331.85Generic · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
Vantra100 mgTablet · Oral use12 BlisterSAR 143.85Generic · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
Vantra200 mgTablet · Oral use12 BlisterSAR 143.85Generic · PrescriptionSPIMACO ADDWAEIHWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

BENIGN PROSTATIC HYPERTROPHY

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

ProductStrengthForm · routeApplicantStatusFirst approved
STENDRA50MG; 100MG; 200MGtablet · oralVIVUS LLCPrescription27 Apr 2012
AVANAFIL50MG; 100MG; 200MGtablet · oralHETERO LABS LTD VPrescription14 Jun 2024

EMA European Union — centrally authorised medicines

Spedra Phoenix Labs Unlimited Company · Authorised · authorised 21 Jun 2013 · ATC G04BE10

Therapeutic indication (EMA)

Treatment of erectile dysfunction in adult men. In order for Spedra to be effective, sexual stimulation is required.

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACAVANAFIL 200 MG TABLET$49.99744per EA23 Sep 2026
NHS Drug TariffAvanafil 100mg tablets£14.084 tablet1 Oct 2026
NHS Drug TariffAvanafil 100mg tablets£26.268 tablet1 Oct 2026
NHS Drug TariffAvanafil 200mg tablets£21.904 tablet1 Oct 2026
NHS Drug TariffAvanafil 200mg tablets£39.408 tablet1 Oct 2026
NHS Drug TariffAvanafil 50mg tablets£10.944 tablet1 Oct 2026
NHS Drug TariffAvanafil 50mg tablets£19.708 tablet1 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 18 Oct 2022 STENDRA — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for avanafil →

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.