Regulatory PathRegulatory requirements compared

Active substance

Pivmecillinam

Open in the medicines table

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

ProductStrengthForm · routeApplicantStatusFirst approved
PIVYAEQ 185MG BASEtablet · oralALEMBIC THERAPPrescription24 Apr 2024

UK MHRA United Kingdom — marketing authorisations

ProductAuthorisationHolderLegal status
PIVMECILLINAM HYDROCHLORIDE 200 MG FILM-COATED TABLETSPL 16363/0442MILPHARM LIMITEDPOM
SELEXID 200MG FILM-COATED TABLETSPL 50567/0003KARO HEALTHCARE ABPOM

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
NHS Drug TariffPivmecillinam 200mg tablets£5.4010 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.

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), MHRA category lists of UK marketing authorisations (Open Government Licence v3.0), 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.