Regulatory PathRegulatory requirements compared

Active substance

Valganciclovir

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade nameStrengthForm · routePackPublic priceTypeCompanyStatus
VALCYTE 450MG FILM - COATED TABLETS450 mgFilm-coated tablet · Oral use60 BlisterSAR 3791.75NCE · PrescriptionCHEPLAPHARM Arzneimittel GmbHValid
VALGAN450 mgFilm-coated tablet · Oral use60 BlisterSAR 2499.85Generic · PrescriptionSaudi AmaroxValid
VALGAN 50MG/ML POWDER FOR ORAL SOLUTION50 mg/mlPowder for oral solution · Oral use1 BottleSAR 1270.50Generic · PrescriptionSaudi AmaroxValid
VERCANZA 450 MG FILM COATED TABLET450 mgFilm-coated tablet · Oral use60 BottleSAR 3686.50Generic · PrescriptionSPIMACO ADDWAEIHValid
Valgaset450 mgTablet · Oral use60 BlisterSAR 2499.85Generic · PrescriptionALTAIF PHARMACEUTICALS COMPANYValid
Valgiver450 mgFilm-coated tablet · Oral use60 BottleSAR 2499.85Generic · PrescriptionADEL AHMED AL-SHAEIR PHARMACEUTICAL COMPANYValid
Indications — CHI Daman Drug Formulary

CASTLEMAN DISEASE; HERPESVIRAL KERATITIS,ZOSTER KERATITIS, KERATITIS,OTHER CYTOMEGALOVIRAL DISEASES; HUMAN IMMUNODEFICIENCY VIRUS; RENAL TRANSPLANT; VIRAL GASTROENTERITIS

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

ProductStrengthForm · routeApplicantStatusFirst approved
VALCYTE50MG/MLfor solution · oralCHEPLAPHARMPrescription28 Aug 2009
VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASEtablet · oralSTRIDES PHARMA INTLPrescription4 Nov 2014
VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASEtablet · oralDR REDDYSPrescription4 Nov 2014
VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASEtablet · oralHETERO LABS LTD VPrescription18 Mar 2016
VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASEtablet · oralAUROBINDO PHARMA LTDPrescription31 Mar 2016
VALGANCICLOVIR HYDROCHLORIDE50MG/MLfor solution · oralACTAVIS LABS FL INCPrescription18 Jul 2016
VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASEtablet · oralDR REDDYSPrescription12 Dec 2017
VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASEtablet · oralAJANTA PHARMA LTDPrescription26 Dec 2019
VALGANCICLOVIR HYDROCHLORIDE50MG/MLfor solution · oralAJANTA PHARMA LTDPrescription13 Jan 2020
VALGANCICLOVIR HYDROCHLORIDE50MG/MLfor solution · oralGRANULESPrescription31 Jan 2020
VALGANCICLOVIR HYDROCHLORIDE50MG/MLfor solution · oralMSNPrescription17 Feb 2022
VALGANCICLOVIR HYDROCHLORIDE50MG/MLfor solution · oralHETERO LABS LTD VPrescription4 Oct 2022
VALGANCICLOVIR HYDROCHLORIDE50MG/MLfor solution · oralAUROBINDO PHARMAPrescription17 Nov 2022
VALGANCICLOVIR HYDROCHLORIDE50MG/MLfor solution · oralAPPCOPrescription11 Apr 2023
VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASEtablet · oralSOMERSET THERAPS LLCPrescription11 Jun 2024
VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASEtablet · oralSPH ZHONGXI PHARMPrescription16 Apr 2025
VALGANCICLOVIR HYDROCHLORIDE50MG/MLfor solution · oralMICRO LABSPrescription19 Mar 2026
VALCYTEEQ 450MG BASEtablet · oralCHEPLAPHARMDiscontinued29 Mar 2001
VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASEtablet · oralCIPLADiscontinued9 Nov 2018
VALGANCICLOVIR HYDROCHLORIDEEQ 450MG BASEtablet · oralPHARMOBEDIENTDiscontinued3 Mar 2021

Canada Canada — marketed products (Health Canada)

BrandDINStrengthForm · routeCompany
AURO-VALGANCICLOVIR02435179450 MGTABLET · ORALAURO PHARMA INC
AURO-VALGANCICLOVIR0253548350 MG / MLPOWDER FOR SOLUTION · ORALAURO PHARMA INC
MINT-VALGANCICLOVIR02495457450 MGTABLET · ORALMINT PHARMACEUTICALS INC
TEVA-VALGANCICLOVIR02413825450 MGTABLET · ORALTEVA CANADA LIMITED
VALCYTE02245777450 MGTABLET · ORALCHEPLAPHARM ARZNEIMITTEL GMBH
VALCYTE0230608550 MG / MLPOWDER FOR SOLUTION · ORALCHEPLAPHARM ARZNEIMITTEL GMBH

Prices — United States and England

SourceProduct as listedPriceUnit / packDate
US NADACVALGANCICLOVIR 450 MG TABLET$1.91499per EA23 Sep 2026
US NADACVALGANCICLOVIR HCL 50 MG/ML$1.00585per ML23 Sep 2026
NHS Drug TariffValganciclovir 450mg tablets£1081.4660 tablet1 Oct 2026
NHS Drug TariffValganciclovir 50mg/ml oral solution sugar free£230.3288 ml1 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)

  • 6.4.3. Other antivirals · core (EML); complementary (EMLc)
    Cytomegaloviral retinitis
    Oral > Liquid: 50 mg per mL (as hydrochloride) powder for oral solution (EMLc) | Oral > Solid > tablet: 450 mg (as hydrochloride)

Safety signals and safety-related labeling changes

  • US FDA 2 Aug 2018 VALCYTE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
  • US FDA 2 Aug 2018 VALCYTE — safety-related labeling change
    Labeling sections changed: Boxed Warning; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for valganciclovir →

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.