Is Imiquimod registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Imiquimod, including ALDARA 5% CREAM (5 %, Cream, SAR 242.85); KOZAMOD 5% CREAM (5 %, Cream, SAR 140.50).

Is Imiquimod approved by the US FDA?

Drugs@FDA lists 12 application product lines for Imiquimod, including IMIQUIMOD (Prescription); ZYCLARA (Prescription); IMIQUIMOD (Prescription); ZYCLARA (Prescription); IMIQUIMOD (Prescription).

Is Imiquimod authorised in the European Union?

EMA lists 2 centrally authorised medicines containing Imiquimod: Aldara, Zyclara.

Are there safety signals or safety updates for Imiquimod?

EMA PRAC: 2 entries; US FDA: 2 entries (latest 2024-09-25).

Active substance

Imiquimod

SFDA 3
US FDA 12
EMA 3
Health Canada 4
US price lines 4
NHS prices 2
Safety 4

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ALDARA 5% CREAM	5 %	Cream · Topical	12 Sachet	SAR 242.85	NCE · Prescription	MEDA PHARMA GmbH & Co KG	Valid
KOZAMOD 5% CREAM	5 %	Cream · Topical	12 Sachet	SAR 140.50	Generic · Prescription	Glenmark Pharmaceuticals Limited	Valid
Jedara	5 %	Cream · Cutaneous use	12 Sachet	SAR 140.50	Generic · Prescription	JERASH PHARMACEUTICAL L.T.D	Suspended · Not Marketed

Indications — CHI Daman Drug Formulary

ANOGENITAL WARTS; MOLLUSCUM CONTAGIOSUM

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

Product	Strength	Form · route	Applicant	Status	First approved
IMIQUIMOD	5%	cream · topical	FOUGERA PHARMS	Prescription	25 Feb 2010
ZYCLARA	3.75%; 2.5%	cream · topical	BAUSCH	Prescription	25 Mar 2010
IMIQUIMOD	5%	cream · topical	PADAGIS ISRAEL	Prescription	7 Sep 2010
ZYCLARA	3.75%	cream · topical	GRACEWAY	Prescription	24 Mar 2011
IMIQUIMOD	5%	cream · topical	TARO	Prescription	15 Apr 2011
IMIQUIMOD	5%	cream · topical	GLENMARK PHARMS	Prescription	6 Mar 2012
IMIQUIMOD	3.75%	cream · topical	TARO	Prescription	26 Jan 2021
ALDARA	5% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	cream · topical	BAUSCH	Discontinued	27 Feb 1997
IMIQUIMOD	5%	cream · topical	ENCUBE	Discontinued	28 Feb 2011
IMIQUIMOD	5%	cream · topical	COSETTE PHARMS NC	Discontinued	18 Apr 2011
IMIQUIMOD	5%	cream · topical	APOTEX INC	Discontinued	6 Apr 2012
IMIQUIMOD	5%	cream · topical	STRIDES PHARMA	Discontinued	24 Jun 2014

EMA European Union — centrally authorised medicines

Aldara Viatris Healthcare Limited · Authorised · authorised 18 Sep 1998 · ATC D06BB10

Therapeutic indication (EMA)

Imiquimod cream is indicated for the topical treatment of : External genital and perianal warts (condylomata acuminata) in adults. Small superficial basal cell carcinomas (sBCCs) in adults. Clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when size or number of lesions limit the efficacy and/or acceptability of cryotherapy and other topical treatment options are contraindicated or less appropriate.

Zyclara Viatris Healthcare Limited · Authorised · authorised 23 Aug 2012 · ATC D06BB10

Therapeutic indication (EMA)

Zyclara is indicated for the topical treatment of clinically typical, non-hyperkeratotic, non-hypertrophic, visible or palpable actinic keratosis of the full face or balding scalp in immunocompetent adults when other topical treatment options are contraindicated or less appropriate.

Zartra Laboratoires 3M Santé · Withdrawn · authorised 18 Sep 1998 · ATC L03AX

Therapeutic indication (EMA)

Imiquimod cream is indicated for the topical treatment of external genital and perianal warts (condyloma acuminata) in adult patients.

Canada Canada — marketed products (Health Canada)

Brand	DIN	Strength	Form · route	Company
ALDARA P	02239505	5 %	CREAM · TOPICAL	BAUSCH HEALTH, CANADA INC.
TARO-IMIQUIMOD PUMP	02482983	5 % / W/W	CREAM · TOPICAL	TARO PHARMACEUTICALS INC
VYLOMA	02365561	3.75 % / W/W	CREAM · TOPICAL	BAUSCH HEALTH, CANADA INC.
ZYCLARA	02340445	3.75 % / W/W	CREAM · TOPICAL	BAUSCH HEALTH, CANADA INC.

Prices — United States and England

Source	Product as listed	Price	Unit / pack	Date
US NADAC	IMIQUIMOD 3.75% CREAM	$36.22845	per EA	23 Sep 2026
US NADAC	IMIQUIMOD 3.75% CREAM PUMP	$113.12147	per GM	23 Sep 2026
US NADAC	IMIQUIMOD 5% CREAM PACKET	$12.16546	per EA	23 Sep 2026
US NADAC	IMIQUIMOD 5% CREAM PACKET	$0.60994	per EA	23 Sep 2026
NHS Drug Tariff	Imiquimod 3.75% cream 250mg sachets	£54.75	28 sachet	1 Oct 2026
NHS Drug Tariff	Imiquimod 5% cream 250mg sachets	£48.60	12 sachet	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 25 Sep 2024 ALDARA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
US FDA 16 Sep 2024 ZYCLARA — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide
EMA PRAC 31 Oct 2019 PRAC signal: Pemphigus
Action for MAH: update of the product information: No
EMA PRAC 11 Jul 2019 PRAC signal: Pemphigus
Action for MAH: update of the product information: No

All safety entries for imiquimod →

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.