Is Voriconazole registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 24 valid registrations of Voriconazole, including VECANZOL (200 mg, Powder for solution for infusion, SAR 283.10); VFEND 200MG POWDER FOR SOLU.FOR INFUSION (200 mg, Powder for solution for infusion, SAR 311.45); VFEND 200MG TABLET (200 mg, Film-coated tablet, SAR 2463.95); VFEND 40MG/ML POWDER FOR SUSPENSION (40 mg/ml, Powder for oral suspension, SAR 1470.25); VFEND 50MG TABLET (50 mg, Film-coated tablet, SAR 616.00).

Is Voriconazole approved by the US FDA?

Drugs@FDA lists 37 application product lines for Voriconazole, including VFEND (Prescription); VFEND (Prescription); VFEND (Prescription); VFEND (Prescription); VFEND (Prescription).

Is Voriconazole authorised in the European Union?

EMA lists 3 centrally authorised medicines containing Voriconazole: Vfend, Voriconazole Accord, Voriconazole Hikma (previously Voriconazole Hospira).

Is Voriconazole on the WHO Model List of Essential Medicines?

Yes — 6.3. Antifungal medicines (core list): Chronic pulmonary aspergillosis; Invasive aspergillosis.

Are there safety signals or safety updates for Voriconazole?

EMA PRAC: 3 entries; US FDA: 4 entries; MHRA: 1 entry (latest 2026-02-19).

Active substance

Voriconazole

SFDA 29
US FDA 37
EMA 3
Health Canada 11
US price lines 3
NHS prices 4
WHO EML 1
Safety 8

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
VECANZOL	200 mg	Powder for solution for infusion · Intravenous use	1 Vial	SAR 283.10	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
VFEND 200MG POWDER FOR SOLU.FOR INFUSION	200 mg	Powder for solution for infusion · Parenteral use	1 Vial	SAR 311.45	NCE · Prescription	Pfizer Europe MA EEIG	Valid
VFEND 200MG TABLET	200 mg	Film-coated tablet · Oral use	30 Blister	SAR 2463.95	NCE · Prescription	Pfizer Europe MA EEIG	Valid
VFEND 40MG/ML POWDER FOR SUSPENSION	40 mg/ml	Powder for oral suspension · Oral use	1 Bottle	SAR 1470.25	NCE · Prescription	Pfizer Europe MA EEIG	Valid
VFEND 50MG TABLET	50 mg	Film-coated tablet · Oral use	30 Blister	SAR 616.00	NCE · Prescription	Pfizer Europe MA EEIG	Valid
VFONAZ 200 mg film-coated tablet	200 mg	Film-coated tablet · Oral use	30 Blister	SAR 2334.30	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
VFONAZ 200 mg powder for solution for infusion	200 mg	Solution · Intravenous use	1 Vial	SAR 295.00	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
VFONAZ 50 mg film-coated tablet	50 mg	Film-coated tablet · Oral use	30 Blister	SAR 583.56	Generic · Prescription	Tabuk Pharmaceutical Manufacturing Company	Valid
VOCONZA 40MG/ML ORAL SUSPENSION	40 mg/ml	Oral suspension · Oral use	1 Bottle	SAR 1396.75	Generic · Prescription	Saudi Amarox	Valid
VOLCON 200 mg film-coated tablet	200 mg	Film-coated tablet · Oral use	30 Blister	SAR 2334.30	Generic · Prescription	Pharma International Co.	Valid
VORIC	200 mg	Powder for solution for infusion · Intravenous use	1 Vial	SAR 295.00	Generic · Prescription	AJA PHARMACEUTICAL INDUSTRIES	Valid
VULTERA 200 mg Film Coated Tablet	200 mg	Film-coated tablet · Oral use	30 Blister	SAR 2334.30	Generic · Prescription	SPIMACO ADDWAEIH	Valid
VULTERA 50 mg Film Coated Tablet	50 mg	Film-coated tablet · Oral use	30 Blister	SAR 583.55	Generic · Prescription	SPIMACO ADDWAEIH	Valid
Vecanzol	40 mg/ml	Powder for oral solution · Oral use	1 Bottle	SAR 1269.45	Generic · Prescription	MS Pharma Saudi (MSPS)	Valid
Voconza	200 mg	Injection · Intravenous use	10 Vial	SAR 2831.00	Generic · Prescription	Saudi Amarox	Valid
Vodar	50 mg	Film-coated tablet · Oral use	30 Blister	SAR 583.55	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Vodar	200 mg	Film-coated tablet · Oral use	30 Blister	SAR 2334.30	Generic · Prescription	Pharma Pharmaceutical Industries (PPI)	Valid
Vorican	200 mg	Powder for solution for infusion · Intravenous use	1 Vial	SAR 283.10	Generic · Prescription	SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO	Valid
Voricet	200 mg	Powder for solution for infusion · Parenteral use	1 Vial	SAR 289.05	Generic · Prescription	HEXAL AG	Valid
Voricet	200 mg	Film-coated tablet · Oral use	30 Blister	SAR 1858.85	Generic · Prescription	Sandoz GmbH	Valid
Voriconazole MCP	200 mg	Film-coated tablet · Oral use	30 Blister	SAR 2334.30	Generic · Prescription	Med City Pharma	Valid
Voriole	200 mg	Powder for solution for infusion · Intravenous use	1 Vial	SAR 198.15	Generic · Prescription	Boston Oncology Arabia	Valid
Vostifaz	200 mg	Film-coated tablet · Oral use	30 Blister	SAR 1634.00	Generic · Prescription	ALPHA PHARMA INDUSTRY	Valid
Vresq	200 mg	powder for solution for injection · Intravenous use	1 Vial	SAR 283.10	Generic · Prescription	ADEL AHMED AL-SHAEIR PHARMACEUTICAL COMPANY	Valid
VFEND 200MG POWDER FOR SOLU.FOR INFUSION	200 mg	Powder for solution for infusion · Parenteral use	1 Vial	SAR 483.90	NCE · Prescription	PFIZER	Withdrawn by MAH · Not Marketed

4 more — full table

Indications — CHI Daman Drug Formulary

ANTIMICROBIAL PROPHYLAXIS IN CANCER PATIENTS; CYSTIC FIBROSIS; ESOPHAGEAL CANDIDIASIS; FUNGAL GIT - ASPERGILLOSIS; FUNGAL SKIN INFECTION - ASPERGILLOSIS; INTRA-ABDOMINAL INFECTIONS; Invasive Candidiasis and Candidemia; PERITONITIS, PERITONEAL DIALYSIS-RELATED PERITONITIS; Pyogenic Arthritis

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

Product	Strength	Form · route	Applicant	Status	First approved
VFEND	50MG; 200MG	tablet · oral	PF PRISM CV	Prescription	24 May 2002
VFEND	200MG/VIAL	powder · intravenous	PF PRISM CV	Prescription	24 May 2002
VFEND	50MG; 200MG	tablet · oral	PFIZER	Prescription	14 Nov 2003
VFEND	200MG	injectable · injection	PFIZER	Prescription	14 Nov 2003
VFEND	50MG; 200MG	tablet · oral	PFIZER	Prescription	14 Nov 2003
VFEND	200MG/VIAL	injectable · iv (infusion)	PFIZER	Prescription	14 Nov 2003
VFEND	200MG/5ML	for suspension · oral	PF PRISM CV	Prescription	19 Dec 2003
VORICONAZOLE	50MG; 200MG	tablet · oral	MYLAN PHARMS INC	Prescription	22 Apr 2010
VORICONAZOLE	50MG; 200MG	tablet · oral	SANDOZ INC	Prescription	12 Dec 2011
VORICONAZOLE	200MG/VIAL	powder · intravenous	SANDOZ INC	Prescription	30 May 2012
VORICONAZOLE	50MG; 200MG	tablet · oral	GLENMARK PHARMS LTD	Prescription	2 Sep 2015
VORICONAZOLE	50MG; 200MG	tablet · oral	AUROBINDO PHARMA LTD	Prescription	22 Jan 2016
VORICONAZOLE	200MG/5ML	for suspension · oral	AMNEAL PHARMS	Prescription	13 Apr 2016
VORICONAZOLE	50MG; 200MG	tablet · oral	AJANTA PHARMA LTD	Prescription	24 May 2016
VORICONAZOLE	50MG; 200MG	tablet · oral	CADILA	Prescription	24 May 2016
VORICONAZOLE	50MG; 200MG	tablet · oral	RISING	Prescription	24 May 2016
VORICONAZOLE	50MG; 200MG	tablet · oral	CHARTWELL RX	Prescription	24 May 2016
VORICONAZOLE	200MG/5ML	for suspension · oral	NOVEL LABS INC	Prescription	31 May 2016
VORICONAZOLE	50MG; 200MG	tablet · oral	PRINSTON INC	Prescription	8 Aug 2016
VORICONAZOLE	50MG; 200MG	tablet · oral	EPIC PHARMA LLC	Prescription	7 Sep 2016
VORICONAZOLE	200MG/VIAL	powder · intravenous	HIKMA PHARMS	Prescription	9 Mar 2017
VORICONAZOLE	200MG	injectable · injection	HIKMA PHARMS	Prescription	9 Mar 2017
VORICONAZOLE	200MG/VIAL	powder · intravenous	ZYDUS PHARMS	Prescription	16 Jul 2018
VORICONAZOLE	200MG/VIAL	powder · intravenous	HAINAN POLY	Prescription	30 Nov 2018
VORICONAZOLE	200MG/VIAL	powder · intravenous	GLAND	Prescription	31 Mar 2020

12 more — full table

EMA European Union — centrally authorised medicines

Vfend Pfizer Europe MA EEIG · Authorised · authorised 19 Mar 2002 · ATC J02AC03

Therapeutic indication (EMA)

Voriconazole, is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis; treatment of in candidaemianon-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Vfend should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT) recipients.

Voriconazole Accord Accord Healthcare S.L.U. · Authorised · authorised 16 May 2013 · ATC J02AC03

Therapeutic indication (EMA)

Voriconazole is a broad-spectrum, triazole antifungal agent and is indicated in adults and children aged two years and above as follows: treatment of invasive aspergillosis; treatment of candidaemia in non-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); Treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Voriconazole Accord should be administered primarily to patients with progressive, possibly life-threatening infections.

Voriconazole Hikma (previously Voriconazole Hospira) Hikma Farmaceutica (Portugal) S.A. · Authorised · authorised 27 May 2015 · ATC J02AC03

Therapeutic indication (EMA)

Voriconazole is a broad spectrum, triazole antifungal agent and is indicated in adults and children aged 2 years and above as follows: treatment of invasive aspergillosis; treatment of candidaemia in non-neutropenic patients; treatment of fluconazole-resistant serious invasive Candida infections (including C. krusei); treatment of serious fungal infections caused by Scedosporium spp. and Fusarium spp. Voriconazole should be administered primarily to patients with progressive, possibly life-threatening infections. Prophylaxis of invasive fungal infections in high risk allogeneic hematopoietic stem cell transplant (HSCT)recipients.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
JAMP VORICONAZOLE	02525771	50 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
JAMP VORICONAZOLE	02525798	200 MG	TABLET · ORAL	JAMP PHARMA CORPORATION
SANDOZ VORICONAZOLE	02399245	50 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
SANDOZ VORICONAZOLE	02399253	200 MG	TABLET · ORAL	SANDOZ CANADA INCORPORATED
VFEND	02256460	50 MG	TABLET · ORAL	PFIZER CANADA ULC
VFEND	02256479	200 MG	TABLET · ORAL	PFIZER CANADA ULC
VFEND	02256487	200 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	PFIZER CANADA ULC
VFEND	02279991	200 MG / 5 ML	POWDER FOR SUSPENSION · ORAL	PFIZER CANADA ULC
VORICONAZOLE FOR INJECTION	02381966	200 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	SANDOZ CANADA INCORPORATED
VORICONAZOLE FOR INJECTION	02477696	200 MG / VIAL	POWDER FOR SOLUTION · INTRAVENOUS	JAMP PHARMA CORPORATION
VORICONAZOLE FOR INJECTION	02493829	200 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	VORICONAZOLE 200 MG TABLET	$1.88461	per EA	30 Sep 2026
US NADAC	VORICONAZOLE 40 MG/ML SUSP	$5.49395	per ML	19 Aug 2026
US NADAC	VORICONAZOLE 50 MG TABLET	$0.82746	per EA	30 Sep 2026
NHS Drug Tariff	Voriconazole 100mg tablets	£275.68	28 tablet	1 Oct 2026
NHS Drug Tariff	Voriconazole 200mg tablets	£1102.74	28 tablet	1 Oct 2026
NHS Drug Tariff	Voriconazole 200mg/5ml oral suspension	£551.37	70 ml	1 Oct 2026
NHS Drug Tariff	Voriconazole 50mg tablets	£275.68	28 tablet	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.

WHO WHO Model List of Essential Medicines (2025)

6.3. Antifungal medicines · core
Chronic pulmonary aspergillosis; Invasive aspergillosis
Parenteral > General injections > IV: 200 mg in vial powder for injection | Oral > Liquid: 40 mg per mL powder for oral liquid | Oral > Solid: 50 mg tablet; 200 mg tablet

Safety signals and safety-related labeling changes

US FDA 19 Feb 2026 VFEND — 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
US FDA 19 Feb 2026 VFEND — 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
US FDA 19 Feb 2026 VFEND — 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
US FDA 18 Apr 2025 VORICONAZOLE — 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
EMA PRAC 16 Mar 2023 PRAC signal: Drug interaction with flucloxacillin leading to subtherapeutic voriconazole levels
Action for MAH: update of the product information: Yes
EMA PRAC 27 Oct 2022 PRAC signal: Drug interaction with flucloxacillin leading to subtherapeutic voriconazole levels
Action for MAH: update of the product information: No
EMA PRAC 6 Sep 2018 PRAC signal: Drug reaction with eosinophilia and systemic symptoms (DRESS)
Action for MAH: update of the product information: No
MHRA 11 Dec 2014 Voriconazole: reminder of risk of liver toxicity, phototoxicity, and squamous cell carcinoma
Test liver function before and during treatment and tell patients to avoid sunlight exposure.

All safety entries for voriconazole →

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.