Regulatory PathRegulatory requirements compared

Active substance

Famciclovir

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
FAMVIR 125MGTAB125 mgFilm-coated tablet · Oral use10 BlisterSAR 96.25NCE · PrescriptionAtnahs Pharma UK LimitedValid
FAMVIR 250MG TAB250 mgFilm-coated tablet · Oral use21 BlisterSAR 414.75NCE · PrescriptionAtnahs Pharma UK LimitedValid
Zostivr500 mgFilm-coated tablet · Oral use30 BlisterSAR 1100.00Generic · PrescriptionSaudi AmaroxValid
Zostivr250 mgFilm-coated tablet · Oral use30 BlisterSAR 550.00Generic · PrescriptionSaudi AmaroxValid
Indications — CHI Daman Drug Formulary

CHICKENPOX (VARICELLA); HERPES SIMPLEX VIRUS (HERPES LABIALIS); HERPES ZOSTER (SHINGLES); HERPESVIRAL KERATITIS, ZOSTER KERATITIS, KERATITIS, VARICELLA KERATITIS; MULTIPLE MYELOMA

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

ProductStrengthForm · routeApplicantStatusFirst approved
FAMCICLOVIR125MG; 250MG; 500MGtablet · oralTEVA PHARMSPrescription24 Aug 2007
FAMCICLOVIR125MG; 250MG; 500MGtablet · oralAUROBINDO PHARMA LTDPrescription21 Mar 2011
FAMCICLOVIR125MG; 250MG; 500MGtablet · oralMACLEODS PHARMS LTDPrescription12 Jan 2012
FAMCICLOVIR125MG; 250MG; 500MGtablet · oralHETERO LABS LTD VPrescription10 Sep 2014
FAMVIR250MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 500MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**; 125MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**tablet · oralNOVARTISDiscontinued29 Jun 1994
FAMCICLOVIR125MG; 250MG; 500MGtablet · oralCIPLADiscontinued21 Mar 2011
FAMCICLOVIR125MG; 250MG; 500MGtablet · oralHIKMA PHARMSDiscontinued21 Mar 2011
FAMCICLOVIR125MG; 250MG; 500MGtablet · oralNATCO PHARMADiscontinued24 Mar 2011
FAMCICLOVIR125MG; 250MG; 500MGtablet · oralAPOTEXDiscontinued22 Jul 2011

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
APO-FAMCICLOVIR02292025125 MGTABLET · ORALAPOTEX INC
APO-FAMCICLOVIR02292041250 MGTABLET · ORALAPOTEX INC
APO-FAMCICLOVIR02292068500 MGTABLET · ORALAPOTEX INC
FAMVIR02177102500 MGTABLET · ORALSEARCHLIGHT PHARMA INC
FAMVIR02229110125 MGTABLET · ORALSEARCHLIGHT PHARMA INC
FAMVIR02229129250 MGTABLET · ORALSEARCHLIGHT PHARMA INC

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACFAMCICLOVIR 125 MG TABLET$0.21439per EA23 Sep 2026
US NADACFAMCICLOVIR 250 MG TABLET$0.44249per EA23 Sep 2026
US NADACFAMCICLOVIR 500 MG TABLET$0.7878per EA23 Sep 2026
NHS Drug TariffFamciclovir 125mg tablets£53.4510 tablet1 Oct 2026
NHS Drug TariffFamciclovir 250mg tablets£148.2515 tablet1 Oct 2026
NHS Drug TariffFamciclovir 250mg tablets£207.5521 tablet1 Oct 2026
NHS Drug TariffFamciclovir 250mg tablets£553.4656 tablet1 Oct 2026
NHS Drug TariffFamciclovir 500mg tablets£269.0714 tablet1 Oct 2026
NHS Drug TariffFamciclovir 500mg tablets£641.2130 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 Dec 2018 FAMVIR — safety-related labeling change
    Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for famciclovir →

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.