Regulatory PathRegulatory requirements compared

Active substance

Penciclovir

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
Penovar1 % (W/W)Cream · Topical1 TubeSAR 25.35Generic · PrescriptionBATTERJEE PHARMACETICAL FACTORYValid

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

ProductStrengthForm · routeApplicantStatusFirst approved
DENAVIR1%cream · topicalMYLANPrescription24 Sep 1996
PENCICLOVIR1%cream · topicalTEVA PHARMS USAPrescription9 Nov 2022
PENCICLOVIR1%cream · topicalTORRENTPrescription7 Aug 2023
PENCICLOVIR1%cream · topicalPADAGIS ISRAELPrescription27 Sep 2024
PENCICLOVIR1%cream · topicalAMNEALPrescription22 Aug 2025

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACDENAVIR 1% CREAM$155.076per GM23 Sep 2026
US NADACPENCICLOVIR 1% CREAM$52.1538per GM23 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.

Safety signals and safety-related labeling changes

All safety entries for penciclovir →

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.