Regulatory PathRegulatory requirements compared

Active substance

Dosulepin

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
PROTHIADEN 25MG CAPS25 mgCapsule, hard · Oral use100 BlisterSAR 26.20NCE · PrescriptionRECKITT BENCKISER HEALTHCARE INTERNATIONALInvalid · Not Marketed
PROTHIADEN TAB 75MG75 mgTablet · Oral use28 BlisterSAR 22.05NCE · PrescriptionRECKITT BENCKISER HEALTHCARE INTERNATIONALInvalid · Not Marketed

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffDosulepin 25mg capsules£6.0228 capsule1 Oct 2026
NHS Drug TariffDosulepin 75mg tablets£5.8328 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

All safety entries for dosulepin →

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.