Regulatory PathRegulatory requirements compared

Active substance

Praziquantel

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
BILTRICIDE 600MG TABS600 mgFilm-coated tablet · Oral use4 BlisterSAR 65.90NCE · PrescriptionBAYER AGValid
Indications — CHI Daman Drug Formulary

RENAL TRANSPLANT; SCHISTOSOMIASIS; TAENIASIS; TRAVEL RELATED INFECTIONS-TREATMENT

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

ProductStrengthForm · routeApplicantStatusFirst approved
PRAZIQUANTEL600MGtablet · oralPH HEALTHPrescription27 Nov 2017
BILTRICIDE600MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralBAYER HLTHCAREDiscontinued29 Dec 1982

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACPRAZIQUANTEL 600 MG TABLET$53.24776per EA23 Sep 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)

  • 6.1.4. Cysticidal medicines · complementary
    Cysticercosis of central nervous system
    Oral > Solid > tablet: 600 mg (scored); 500 mg; 150 mg
  • 6.1.3. Antischistosomals and other antitrematode medicines · core
    Paragonimiasis; Clonorchiasis; Opisthorchiasis; Schistosomiasis
    Oral > Solid > tablet: 600 mg (scored); 500 mg; 150 mg
  • 6.1.1. Intestinal anthelminthics · core
    Diphyllobothriasis; Taeniasis due to Taenia saginata; Hymenolepiasis; Taeniasis due to Taenia solium
    Oral > Solid > tablet: 600 mg (scored); 500 mg; 150 mg

Safety signals and safety-related labeling changes

  • US FDA 19 Dec 2023 BILTRICIDE — 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 praziquantel →

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.