Is Ganciclovir registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 3 valid registrations of Ganciclovir, including Cytomag (500 mg, Powder for concentrate for solution for infusion, SAR 158.10); Gavomeg (500 mg, Powder for concentrate for solution for infusion, SAR 166.45); VIRGAN (1.5 mg/g, eye gel, SAR 50.90).

Is Ganciclovir approved by the US FDA?

Drugs@FDA lists 14 application product lines for Ganciclovir, including GANCICLOVIR SODIUM (Prescription); ZIRGAN (Prescription); GANCICLOVIR SODIUM (Prescription); GANCICLOVIR SODIUM (Prescription); GANCICLOVIR SODIUM (Prescription).

Is Ganciclovir authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Ganciclovir.

Are there safety signals or safety updates for Ganciclovir?

US FDA: 3 entries (latest 2026-01-20).

Active substance

Ganciclovir

SFDA 3
US FDA 14
EMA 1
Health Canada 5
US price lines 1
NHS prices 1
Safety 3

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
Cytomag	500 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 158.10	Generic · Prescription	Hainan Poly Pharm. Co., Ltd.	Valid
Gavomeg	500 mg	Powder for concentrate for solution for infusion · Intravenous use	1 Vial	SAR 166.45	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
VIRGAN	1.5 mg/g	eye gel · Ocular use	1 Tube	SAR 50.90	NCE · Prescription	LABORATORIES THEA S.I.S	Valid

Indications — CHI Daman Drug Formulary

CASTLEMAN DISEASE; HERPESVIRAL KERATITIS,ZOSTER KERATITIS, KERATITIS,OTHER CYTOMEGALOVIRAL DISEASES; INFECTIOUS UVEITIS

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

Product	Strength	Form · route	Applicant	Status	First approved
GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	injectable · injection	HIKMA PHARMS	Prescription	16 Jul 2003
ZIRGAN	0.15%	gel · ophthalmic	BAUSCH AND LOMB	Prescription	15 Sep 2009
GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	injectable · injection	FRESENIUS KABI USA	Prescription	21 Jun 2010
GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	injectable · injection	PH HEALTH	Prescription	6 Dec 2016
GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	injectable · injection	PHARMASCIENCE INC	Prescription	8 Dec 2017
GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	injectable · injection	HAINAN POLY	Prescription	8 Nov 2018
CYTOVENE	EQ 500MG BASE/VIAL Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	injectable · injection	CHEPLAPHARM	Discontinued	23 Jun 1989
CYTOVENE	250MG 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	capsule · oral	ROCHE PALO	Discontinued	22 Dec 1994
VITRASERT	4.5MG	implant · implantation	BAUSCH AND LOMB	Discontinued	4 Mar 1996
GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	injectable · injection	AM REGENT	Discontinued	18 Sep 2013
GANZYK-RTU	500MG/250ML (2MG/ML)	solution · intravenous	EXELA PHARMA	Discontinued	17 Feb 2017
GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	injectable · injection	ONESOURCE SPECIALTY	Discontinued	17 Nov 2017
GANCICLOVIR SODIUM	EQ 500MG BASE/VIAL	injectable · injection	CUSTOPHARM INC	Discontinued	20 Jun 2019
GANCICLOVIR	250MG; 500MG	capsule · oral	RANBAXY LABS LTD	Discontinued

EMA European Union — centrally authorised medicines

Vitrasert Implant Dr. Gerhard Mann, Chem.-Pharm. Fabrik GmbH.. · Withdrawn · authorised 18 Mar 1997 · ATC J05AB06

Therapeutic indication (EMA)

The Vitrasert implant is indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) (See 4.4. Special warnings and special precautions for use).

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
CYTOVENE	02162695	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	CHEPLAPHARM ARZNEIMITTEL GMBH
EYEZIRGAN	02530546	0.15 % / W/W	GEL · OPHTHALMIC	LABORATOIRES THEA
GANCICLOVIR FOR INJECTION	02537168	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	FORMATIVE PHARMA INC.
GANCICLOVIR FOR INJECTION USP	02475391	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	STERIMAX INC
GANCICLOVIR FOR INJECTION, USP	02404761	500 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	FRESENIUS KABI CANADA LTD

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	ZIRGAN 0.15% OPHTHALMIC GEL	$91.24108	per GM	23 Sep 2026
NHS Drug Tariff	Ganciclovir 0.15% eye gel	£19.99	5 gram	1 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 20 Jan 2026 ZIRGAN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 6 Aug 2018 CYTOVENE — safety-related labeling change
Labeling sections changed: Boxed Warning; Warnings and Precautions; Use in Specific Populations
US FDA 20 Sep 2017 GANCICLOVIR — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ganciclovir →

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.