NIZORAL

This brand name is authorized in Austria, Australia, Brazil, Canada, Cyprus, Germany, Estonia, Finland, Hong Kong, Ireland, Israel, Japan, Lithuania, Malta, Mexico, Nigeria, Netherlands, New Zealand, Poland, Romania, Singapore, United Kingdom, United States

Active ingredients

The drug NIZORAL contains one active pharmaceutical ingredient (API):

1 Ketoconazole UNII R9400W927I - KETOCONAZOLE

Ketoconazole is an imidazole-dioxolane antimycotic, active against yeasts, including Malassezia and dermatophytes. Read about Ketoconazole

Medication package inserts

Below package inserts are available for further reading:

Title	Information Source	Document Type
NIZORAL Shampoo	Medicines & Healthcare Products Regulatory Agency (GB)	MPI, EU: SmPC

Medicine classification

This drug has been classified in the anatomical therapeutic chemical (ATC) classification system as follows:

ATC code	Group title	Classification
D01AC08	Ketoconazole	D Dermatologicals → D01 Antifungals for dermatological use → D01A Antifungals for topical use → D01AC Imidazole and triazole derivatives
Discover more medicines within D01AC08

Authorization and marketing

This drug has been assigned below unique identifiers within the countries it is being marketed:

Country	Identification scheme	Identifier(s)
Country: AU	Pharmaceutical Benefits Scheme	Identifier(s): 1574W, 9024Y
Country: BR	Câmara de Regulação do Mercado de Medicamentos	Identifier(s): 514502603161319
Country: CA	Health Products and Food Branch	Identifier(s): 02182920
Country: DE	Bundesinstitut für Arzneimittel und Medizinprodukte	Identifier(s): 03265207, 03265213, 09289628, 09289640, 13889819, 13889825
Country: EE	Ravimiamet	Identifier(s): 1018189, 1060940, 1060951, 1060984, 1821204, 1843736, 1850116
Country: FI	Lääkealan turvallisuus- ja kehittämiskeskus	Identifier(s): 393957, 454689, 522237
Country: GB	Medicines & Healthcare Products Regulatory Agency	Identifier(s): 27623, 27655, 27660, 377406, 381563, 80674
Country: HK	Department of Health Drug Office	Identifier(s): 31551
Country: IE	Health Products Regulatory Authority	Identifier(s): 46094, 76333, 76350
Country: IL	מִשְׂרַד הַבְּרִיאוּת	Identifier(s): 1397, 2491
Country: JP	医薬品医療機器総合機構	Identifier(s): 2655709N1053, 2655709Q1025
Country: LT	Valstybinė vaistų kontrolės tarnyba	Identifier(s): 1013162, 1014156, 1063038, 1066508, 1070167, 1075377, 1075481, 1082478, 1083391, 1089259, 1091909, 1092604, 1093129, 1093130
Country: MT	Medicines Authority	Identifier(s): MA830/00401, MA830/00402, PI1438/07301A, PI521/08402A, PI908/06601A
Country: MX	Comisión Federal para la Protección contra Riesgos Sanitarios	Identifier(s): 209M83, 295M89, 94M83
Country: NG	Registered Drug Product Database	Identifier(s): 04-1734
Country: NL	Z-Index G-Standaard	Identifier(s): 12811599
Country: NL	Z-Index G-Standaard, PRK	Identifier(s): 23264
Country: NZ	Medicines and Medical Devices Safety Authority	Identifier(s): 3393, 3394, 3395
Country: PL	Rejestru Produktów Leczniczych	Identifier(s): 100047790, 100047808, 100260710, 100260761, 100264687, 100266812, 100292318, 100327459, 100353630, 100356892, 100363202, 100366264, 100368122, 100413905, 100451660
Country: RO	Agenția Națională a Medicamentului și a Dispozitivelor Medicale	Identifier(s): W57514001, W57514002
Country: SG	Health Sciences Authority	Identifier(s): 01117P, 04926P
Country: US	FDA, National Drug Code	Identifier(s): 50458-680