Regulatory PathRegulatory requirements compared

Active substance

Pyrazinamide

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
PYRAZINAMIDE ANTIBIOTICE500 mgTablet · Oral use100 BlisterSAR 63.40Generic · PrescriptionANTIBIOTIC S.EValid
PZA 500 MG TAB.500 mgTablet · Oral use50 BlisterSAR 33.30NCE · PrescriptionSANDOZWithdrawn by MAH · Not Marketed
Indications — CHI Daman Drug Formulary

PERITONITIS, PERITONEAL DIALYSIS-RELATED PERITONITIS; TUBERCULOSIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
PYRAZINAMIDE500MGtablet · oralNOVITIUM PHARMAPrescription3 Jun 1971
PYRAZINAMIDE500MGtablet · oralHIKMA PHARMSPrescription30 Jun 1992
PYRAZINAMIDE500MGtablet · oralMACLEODS PHARMSPrescription27 Jul 2020

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
PDP-PYRAZINAMIDE00618810500 MGTABLET · ORALPENDOPHARM DIVISION OF PHARMASCIENCE INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPYRAZINAMIDE 500 MG TABLET$1.30807per EA23 Sep 2026
NHS Drug TariffPyrazinamide 500mg tablets£40.0630 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.

WHO WHO Model List of Essential Medicines (2025)

  • 6.2.5. Antituberculosis medicines · core
    Tuberculosis
    Oral > Solid > dispersible tablet: 150 mg | Oral > Solid > tablet: 400 mg; 500 mg

Safety signals and safety-related labeling changes

  • US FDA 5 Dec 2025 RIFATER — safety-related labeling change
    Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for pyrazinamide →

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.